Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

• ClinicalTrials.gov Identifier: NCT02032433
• Recruitment Status: Completed
• First Posted: January 10, 2014
• Results First Posted: January 19, 2018
• Last Update Posted: August 13, 2020
• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC
• Information provided by (Responsible Party): NYU Langone Health

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Opioid Use Disorder
• Interventions: Drug: Extended-Release Naltrexone; Drug: Buprenorphine-Naloxone
• Enrollment: 570

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Period Title: Overall Study
Started	283	287
Completed	205	225
Not Completed	78	62

Baseline Characteristics

Arm/Group Title		Extended-Release Naltrexone	Buprenorphine-Naloxone	Total
Arm/Group Description		Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)	Total of all reporting groups
Overall Number of Baseline Participants		283	287	570
Baseline Analysis Population Description		Adults with DSM-5 OUD with non prescribed opioid use in the past 30 days.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	283 participants	287 participants	570 participants
		34.0 (9.5)	33.7 (9.8)	33.9 (9.63)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	283 participants	287 participants	570 participants
	Female	88	81	169
	Male	195	206	401
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	283 participants	287 participants	570 participants
	Hispanic or Latino	45 15.9%	54 18.8%	99 17.4%
	Not Hispanic or Latino	238 84.1%	233 81.2%	471 82.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	283 participants	287 participants	570 participants
	American Indian or Alaska Native	2 0.7%	2 0.7%	4 0.7%
	Asian	8 2.8%	1 0.3%	9 1.6%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	29 10.2%	28 9.8%	57 10.0%
	White	206 72.8%	215 74.9%	421 73.9%
	More than one race	18 6.4%	14 4.9%	32 5.6%
	Unknown or Not Reported	20 7.1%	27 9.4%	47 8.2%
Randomization status; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	283 participants	287 participants	570 participants
Early randomization		107 37.8%	110 38.3%	217 38.1%
Late randomization		176 62.2%	177 61.7%	353 61.9%

Outcome Measures

1. Primary Outcome

Title	Time to Relapse (Intent to Treat Population)
Description	Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Time Frame	Weeks 3-24

Outcome Measure Data

Analysis Population Description

Intention to treat.

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Median (95% Confidence Interval); Unit of Measure: weeks
	8.4; (3.0 to 23.4)	14.4; (5.1 to 23.4)

2. Primary Outcome

Title	Time to Relapse (Per Protocol Population)
Description	Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Time Frame	Weeks 3-24

Outcome Measure Data

Analysis Population Description

Per protocol population (those successfully inducted onto medication)

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	204	270
Median (95% Confidence Interval); Unit of Measure: weeks
	20.4; (5.4 to 23.4)	15.2; (5.7 to 23.4)

3. Secondary Outcome

Title	Number Successfully Inducted Onto Assigned Study Medication
Description	Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.
Time Frame	Weeks 0-24

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Number; Unit of Measure: participants
	204	270

4. Secondary Outcome

Title	Adverse Events Related to Study Medications
Description	Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.
Time Frame	Weeks 0-36

Outcome Measure Data

Analysis Population Description

These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication.

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	204	270
Measure Type: Number; Unit of Measure: events
	115	113

5. Secondary Outcome

Title	Opioid Abstinence Over Time While on Study Medication (Subjective)
Description	Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.
Time Frame	Weeks 0-24

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	204	270
Median (Inter-Quartile Range); Unit of Measure: days
	123; (18 to 144)	87; (20 to 144)

6. Secondary Outcome

Title	Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0
Description	Alcohol use over time, drinks per day, past 30 days, at week 0
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: drinks per day
	.8 (2.41)	1.2 (3.75)

7. Secondary Outcome

Title	Cigarette Smoking, W0, 10 or Less
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	112 39.6%	109 38.0%

8. Secondary Outcome

Title	Opioid Craving Over Time W0
Description	Opioid craving over time via VAS at week 0
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	68.7 (30.55)	68.8 (30.05)

9. Secondary Outcome

Title	Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
Description	The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	8.6 (6.45)	9.3 (6.63)

10. Secondary Outcome

Title	Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
Description	The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.1 (.2)	.1 (.23)

11. Secondary Outcome

Title	Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Description	The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	5.5 (8.85)	5.9 (10.46)

12. Secondary Outcome

Title	Score on Trail Making Test Part A
Description	Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	26.8 (11.09)	25.8 (10.07)

13. Secondary Outcome

Title	Opioid Abstinence Over Time While on Study Medication (Objective)
Description	A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.
Time Frame	Weeks 0-24

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	204	270
Median (Inter-Quartile Range); Unit of Measure: Weeks
	13; (3 to 21)	11; (3 to 20)

14. Secondary Outcome

Title	Cigarette Smoking, W0 0
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals none
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	17 6.0%	18 6.3%

15. Secondary Outcome

Title	Cigarette Smoking, W0 11-20
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	106 37.5%	112 39.0%

16. Secondary Outcome

Title	Cigarette Smoking, W0 21-30
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	18 6.4%	21 7.3%

17. Secondary Outcome

Title	Cigarette Smoking, W0 31 or More
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	3 1.1%	8 2.8%

18. Secondary Outcome

Title	Cigarette Smoking, W24 0
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals none
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	32 11.3%	29 10.1%

19. Secondary Outcome

Title	Cigarette Smoking
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	70 24.7%	78 27.2%

20. Secondary Outcome

Title	Cigarette Smoking, W24 11-20
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	57 20.1%	71 24.7%

21. Secondary Outcome

Title	Cigarette Smoking, W24 21-30
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	2 0.7%	11 3.8%

22. Secondary Outcome

Title	Cigarette Smoking, W24 31 or More
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	1 0.4%	5 1.7%

23. Secondary Outcome

Title	Score on Opioid Craving Scale (OCS)
Description	OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	9.9 (21.54)	9.4 (17.67)

24. Secondary Outcome

Title	Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
Description	The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	5.2 (6.53)	4.8 (5.48)

25. Secondary Outcome

Title	Score on Subjective Opiate Withdrawal Scale (SOWS)
Description	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	15.6 (13.38)	15.6 (13.15)

26. Secondary Outcome

Title	Score on Subjective Opiate Withdrawal Scale (SOWS)
Description	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	4.5 (7.53)	5.3 (7.49)

27. Secondary Outcome

Title	Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Description	The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	7.3 (9.37)	6.0 (10.63)

28. Secondary Outcome

Title	Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Description	The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	3.6 (7.34)	4.3 (10.07)

29. Secondary Outcome

Title	Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Description	The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	4.8 (8.4)	4.3 (10.34)

30. Secondary Outcome

Title	Score on Trail Making Test Part A
Description	Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	21.6 (9.81)	20.3 (7.03)

31. Secondary Outcome

Title	Score on Trail Making Test Part B
Description	Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	79.1 (40.19)	78.3 (40.73)

32. Secondary Outcome

Title	Score on Trail Making Test Part B
Description	Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	61.2 (39.32)	58.1 (33.37)

33. Secondary Outcome

Title	Score on Word Card of Stoop Test
Description	The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	95.8 (16.6)	96.4 (16.03)

34. Secondary Outcome

Title	Score on Word Card of Stoop Test
Description	The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	103.2 (18.02)	102.9 (19.7)

35. Secondary Outcome

Title	Score on Color Card of Stoop Test
Description	The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	69.3 (13.63)	70.5 (12.46)

36. Secondary Outcome

Title	Score on Color Card of Stoop Test
Description	The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	75.3 (15.31)	76.1 (14.84)

37. Secondary Outcome

Title	Score on Color Word Card of Stoop Test
Description	The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	41.1 (10.33)	42.2 (9.85)

38. Secondary Outcome

Title	Score on Color Word Card of Stoop Test
Description	The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: seconds
	47.6 (12.07)	48.8 (12.35)

39. Secondary Outcome

Title	Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
Description	The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.1 (.11)	0.0 (0.11)

40. Secondary Outcome

Title	Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
Description	The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	0.3 (0.08)	.3 (0.09)

41. Secondary Outcome

Title	Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
Description	The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.1 (.13)	.1 (.12)

42. Secondary Outcome

Title	Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
Description	The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.3 (.25)	.3 (.24)

43. Secondary Outcome

Title	Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
Description	The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.1 (.18)	.1 (.19)

44. Secondary Outcome

Title	Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.2 (.21)	.2 (.21)

45. Secondary Outcome

Title	Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.1 (.17)	.1 (.17)

46. Secondary Outcome

Title	Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.2 (.25)	.2 (.27)

47. Secondary Outcome

Title	Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.1 (.24)	.2 (.25)

48. Secondary Outcome

Title	Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.3 (.22)	.3 (.22)

49. Secondary Outcome

Title	Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	.2 (.21)	.2 (.21)

50. Secondary Outcome

Title	Score on EuroQOL EQ-5D Questionnaire
Description	Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	6.8 (1.44)	6.8 (1.31)

51. Secondary Outcome

Title	Score on EuroQOL EQ-5D Questionnaire
Description	Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: score on a scale
	5.8 (1.15)	6.1 (1.28)

52. Secondary Outcome

Title	Alcohol Use Over Time, Drinks Per Day
Description	Alcohol use over time, drinks per day
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Mean (Standard Deviation); Unit of Measure: drinks per day
	.1 (.82)	.4 (1.57)

53. Secondary Outcome

Title	Other Drug Use Over Time, Cannabis, W0
Description	Other drug use over time measuring cannabis at week 0
Time Frame	week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	123 43.5%	135 47.0%

54. Secondary Outcome

Title	Other Drug Use Over Time, Cannabis, W24
Description	Other drug use over time measuring cannabis at week 24
Time Frame	week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	20 7.1%	20 7.0%

55. Secondary Outcome

Title	Other Drug Use Over Time, Cocaine, W0
Description	Other drug use over time measuring cocaine at week 0
Time Frame	week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	61 21.6%	80 27.9%

56. Secondary Outcome

Title	Other Drug Use Over Time, Cocaine, W24
Description	Other drug use over time measuring cocaine at week 0
Time Frame	week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	5 1.8%	2 0.7%

57. Secondary Outcome

Title	Other Drug Use Over Time, Stimulant, W0
Description	Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0
Time Frame	week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	132 46.6%	166 57.8%

58. Secondary Outcome

Title	Other Drug Use Over Time, Stimulant, W24
Description	Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24
Time Frame	week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description:	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Overall Number of Participants Analyzed	283	287
Measure Type: Count of Participants; Unit of Measure: Participants
	5 1.8%	3 1.0%

Adverse Events

Time Frame	Weeks 0-36
Adverse Event Reporting Description	Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
All-Cause Mortality
	Extended-Release Naltrexone	Buprenorphine-Naloxone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/283 (1.06%)	4/287 (1.39%)
Serious Adverse Events
	Extended-Release Naltrexone	Buprenorphine-Naloxone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	41/283 (14.49%)	31/287 (10.80%)
Eye disorders
Eye disorders † 1	1/283 (0.35%)	0/270 (0.00%)
Gastrointestinal disorders
Gastrointestinal disorders † 1	1/283 (0.35%)	2/270 (0.74%)
General disorders
General disorders and administration site conditions † 1	2/283 (0.71%)	2/270 (0.74%)
Hepatobiliary disorders
Hepatobiliary disorders † 1	0/283 (0.00%)	1/270 (0.37%)
Infections and infestations
Infections and infestations † 1	7/283 (2.47%)	6/287 (2.09%)
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications † 1	17/283 (6.01%)	8/270 (2.96%)
Metabolism and nutrition disorders
Metabolism and nutrition disorders † 1	1/283 (0.35%)	0/270 (0.00%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders † 1	0/283 (0.00%)	1/270 (0.37%)
Nervous system disorders
Nervous system disorders † 1	2/283 (0.71%)	2/270 (0.74%)
Pregnancy, puerperium and perinatal conditions
Pregnancy † 1	0/283 (0.00%)	1/270 (0.37%)
Psychiatric disorders
Psychiatric † 1	10/283 (3.53%)	12/287 (4.18%)
Reproductive system and breast disorders
Reproductive system and breast disorders † 1	1/283 (0.35%)	0/270 (0.00%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders † 1	5/283 (1.77%)	0/270 (0.00%)
1 Term from vocabulary, MedDRA (19.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Extended-Release Naltrexone	Buprenorphine-Naloxone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	118/283 (41.70%)	135/287 (47.04%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders † 1	1/283 (0.35%)	0/287 (0.00%)
Cardiac disorders
Cardiac disorders † 1	1/283 (0.35%)	0/287 (0.00%)
Ear and labyrinth disorders
Ear and labyrinth disorders † 1	1/283 (0.35%)	1/287 (0.35%)
Eye disorders
Eye disorders † 1	6/283 (2.12%)	3/287 (1.05%)
Gastrointestinal disorders
Gastrointestinal † 1	36/283 (12.72%)	58/287 (20.21%)
General disorders
General Disorders and Administration Site Conditions † 1	10/283 (3.53%)	21/287 (7.32%)
Hepatobiliary disorders
Hepatbiliary disorders † 1	1/283 (0.35%)	1/287 (0.35%)
Immune system disorders
Immune system disorders † 1	0/283 (0.00%)	1/287 (0.35%)
Infections and infestations
Infections and infestations † 2	22/283 (7.77%)	22/287 (7.67%)
Injury, poisoning and procedural complications
Injury poisoning and procedural complications † 1	18/283 (6.36%)	22/287 (7.67%)
Investigations
Investigations † 1	10/283 (3.53%)	11/287 (3.83%)
Metabolism and nutrition disorders
Metabolism and nutrition † 1	6/283 (2.12%)	4/287 (1.39%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders † 1	16/283 (5.65%)	15/287 (5.23%)
Nervous system disorders
Nervous system disorders † 2	29/283 (10.25%)	27/287 (9.41%)
Product Issues
Product issues † 1	0/283 (0.00%)	1/287 (0.35%)
Psychiatric disorders
Psychiatric † 1	29/283 (10.25%)	22/287 (7.67%)
Renal and urinary disorders
Renal and urinary disorders † 1	4/283 (1.41%)	5/287 (1.74%)
Reproductive system and breast disorders
Reproductive system and breast disorders † 1	2/283 (0.71%)	3/287 (1.05%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders † 1	7/283 (2.47%)	7/287 (2.44%)
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders † 1	9/283 (3.18%)	7/287 (2.44%)
Social circumstances
Social circumstances † 1	1/283 (0.35%)	0/287 (0.00%)
Surgical and medical procedures
Surgical and medical procedures † 1	0/283 (0.00%)	3/287 (1.05%)
Vascular disorders
Vascular disorders † 1	1/283 (0.35%)	6/287 (2.09%)
1 Term from vocabulary, MedDRA (19.0); 2 Term from vocabulary, MedDRA (10.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: John Rotrosen
• Organization: NYU School of Medicine
• Phone: 646-754-4763
• EMail: john.rotrosen@nyumc.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.

Tsui JI, Campbell ANC, Pavlicova M, Choo TH, Lee JD, Cook RR, Shulman M, Nunes EV, Rotrosen J. Methamphetamine/amphetamine use over time among persons with opioid use disorders treated with buprenorphine/naloxone versus extended-release naltrexone. Drug Alcohol Depend. 2022 Jul 1;236:109469. doi: 10.1016/j.drugalcdep.2022.109469. Epub 2022 Apr 21.

Jelovac A, McLoughlin DM. Twelve-Month Outcomes for Remitters Following Electroconvulsive Therapy for Depression. J Clin Psychiatry. 2022 Apr 18;83(3):21lr14371. doi: 10.4088/JCP.21lr14371. No abstract available.

Na PJ, Scodes J, Fishman M, Rotrosen J, Nunes EV. Co-occurring Depression and Suicidal Ideation in Opioid Use Disorder: Prevalence and Response During Treatment With Buprenorphine-Naloxone and Injection Naltrexone. J Clin Psychiatry. 2022 Apr 18;83(3):21m14140. doi: 10.4088/JCP.21m14140.

Rudolph KE, Shulman M, Fishman M, Diaz I, Rotrosen J, Nunes EV. Association between dynamic dose increases of buprenorphine for treatment of opioid use disorder and risk of relapse. Addiction. 2022 Mar;117(3):637-645. doi: 10.1111/add.15654. Epub 2021 Oct 1.

Nunes EV Jr, Scodes JM, Pavlicova M, Lee JD, Novo P, Campbell ANC, Rotrosen J. Sublingual Buprenorphine-Naloxone Compared With Injection Naltrexone for Opioid Use Disorder: Potential Utility of Patient Characteristics in Guiding Choice of Treatment. Am J Psychiatry. 2021 Jul;178(7):660-671. doi: 10.1176/appi.ajp.2020.20060816. Epub 2021 Jun 25.

Fishman M, Wenzel K, Scodes J, Pavlicova M, Campbell ANC, Rotrosen J, Nunes E. Examination of Correlates of OUD Outcomes in Young Adults: Secondary Analysis From the XBOT Trial. Am J Addict. 2021 Sep;30(5):433-444. doi: 10.1111/ajad.13176. Epub 2021 Jun 1.

Shulman M, Choo TH, Scodes J, Pavlicova M, Wai J, Haenlein P, Tofighi B, Campbell ANC, Lee JD, Rotrosen J, Nunes EV. Association between methadone or buprenorphine use during medically supervised opioid withdrawal and extended-release injectable naltrexone induction failure. J Subst Abuse Treat. 2021 May;124:108292. doi: 10.1016/j.jsat.2021.108292. Epub 2021 Jan 16.

Lee JD, Nunes EV Jr, Novo P, Bachrach K, Bailey GL, Bhatt S, Farkas S, Fishman M, Gauthier P, Hodgkins CC, King J, Lindblad R, Liu D, Matthews AG, May J, Peavy KM, Ross S, Salazar D, Schkolnik P, Shmueli-Blumberg D, Stablein D, Subramaniam G, Rotrosen J. Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018 Jan 27;391(10118):309-318. doi: 10.1016/S0140-6736(17)32812-X. Epub 2017 Nov 14.

Lee JD, Nunes EV, Mpa PN, Bailey GL, Brigham GS, Cohen AJ, Fishman M, Ling W, Lindblad R, Shmueli-Blumberg D, Stablein D, May J, Salazar D, Liu D, Rotrosen J. NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale. Contemp Clin Trials. 2016 Sep;50:253-64. doi: 10.1016/j.cct.2016.08.004. Epub 2016 Aug 10.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02032433
• Other Study ID Numbers: 12-03133; UG1DA013035 ( U.S. NIH Grant/Contract )
• First Submitted: December 30, 2013
• First Posted: January 10, 2014
• Results First Submitted: November 24, 2017
• Results First Posted: January 19, 2018
• Last Update Posted: August 13, 2020