Abuse Liability of Suboxone Versus Subutex

• ClinicalTrials.gov Identifier: NCT00710385
• Recruitment Status: Completed
• First Posted: July 4, 2008
• Results First Posted: December 5, 2016
• Last Update Posted: December 5, 2016
• Sponsor: New York State Psychiatric Institute
• Collaborator: Schering-Plough
• Information provided by (Responsible Party): New York State Psychiatric Institute

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Opioid-related Disorders
• Interventions: Drug: Heroin; Drug: Naloxone; Drug: Low Bup Dose; Drug: High Bup Dose; Drug: Low Bup/Nal Dose; Drug: High Bup/Nal Dose; Drug: Placebo (PCB)
• Enrollment: 19

Participant Flow

Recruitment Details	Enrollment dates: September 10, 2007 - August 13, 2008 Location: Medical clinic
Pre-assignment Details

Arm/Group Title	Intravenous Challenge Doses
Arm/Group Description	This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
Period Title: Overall Study
Started	17 [1]
Completed	12
Not Completed	5
Reason Not Completed
Did not qualify	1
Withdrawal by Subject	1
Undisclosed back pain	1
Physician Decision	1
Undisclosed excessive methadone use	1
[1] 19 participants signed consent for the study 2 withdrew before any study procedures were initiated.

Baseline Characteristics

Arm/Group Title		Challenge Doses
Arm/Group Description		This study employs a within-subjects design, all participant experience all challenge doses.
Overall Number of Baseline Participants		12
Baseline Analysis Population Description		[Not Specified]
Age, Categorical [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	12 100.0%
	>=65 years	0 0.0%
		[1] Measure Description: verbal report verified by ID
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	12 participants
		36.2 (6.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants
	Female	4 33.3%
	Male	8 66.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	12 participants
		12

Outcome Measures

1. Primary Outcome

Title	Drug's Breakpoint
Description	Measure of a drug's reinforcing effects. The "Breakpoint" is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested
Time Frame	Single measurement taken following each of the 7 IV experimental doses

Outcome Measure Data

Analysis Population Description

Heroin users, not seeking treatment

Arm/Group Title	Heroin	Naloxone	Low Bup Dose	High Bup Dose	Lower Bup/Nal Dose	High Bup/Nal Dose	Placebo
Arm/Group Description:	Intravenous heroin 25 mg	Intravenous Naloxone HCl	Lower doses of intravenous buprenorphine alone.	Higher doses of intravenous buprenorphine	Lower doses of intravenous buprenorphine + naloxone.	Higher doses of intravenous buprenorphine +naloxone	Control intravenous placebo drug administration.
Overall Number of Participants Analyzed	12	12	12	12	12	12	12
Mean (Standard Deviation); Unit of Measure: number of clicks on a mouse
	1200 (200)	10 (10)	1100 (180)	1200 (190)	300 (100)	750 (175)	0 (0)

2. Secondary Outcome

Title	Drug "Liking"
Description	Participant's subjective ratings of how much they "Like" the dose they just received on a scale of 0 -100.
Time Frame	Peak (highest) rating obtained following drug administration throughout the entire 3 hr session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Heroin	Naloxone	Low Bup Dose	High Bup Dose	Lower Bup/Nal Dose	High Bup/Nal Dose	Placebo
Arm/Group Description:	Intravenous heroin 25 mg	Intravenous Naloxone HCl	Lower doses of intravenous buprenorphine alone.	Higher doses of intravenous buprenorphine	Lower doses of intravenous buprenorphine + naloxone.	Higher doses of intravenous buprenorphine +naloxone	Control intravenous placebo drug administration.
Overall Number of Participants Analyzed	12	12	12	12	12	12	12
Mean (Standard Error); Unit of Measure: units on a scale
	41.5 (5)	3 (2.7)	29.8 (4)	42.5 (5)	10.5 (2.4)	27 (4)	1 (.6)

Adverse Events

Time Frame	Adverse events were assessed for daily throughout the study.
Adverse Event Reporting Description	An adverse event (AE) was defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that was: Fatal, Life-threatening, Required or prolonged inpatient stay, Resulted in persistent or significant disability or incapacity.
Arm/Group Title	Combined for All Study Conditions
Arm/Group Description	This study employed a within-subjects design, all participants experienced all study conditions.
All-Cause Mortality
	Combined for All Study Conditions
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Combined for All Study Conditions
	Affected / at Risk (%)	# Events
Total	0/17 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Combined for All Study Conditions
	Affected / at Risk (%)	# Events
Total	4/17 (23.53%)
Gastrointestinal disorders
vomiting †	1/17 (5.88%)	1
Injury, poisoning and procedural complications
dizziness †	1/17 (5.88%)	1
chest discomfort †	1/17 (5.88%)	1
Mild Opioid Withdrawal †	3/17 (17.65%)	3
Skin and subcutaneous tissue disorders
urticaria †	2/17 (11.76%)	2
† Indicates events were collected by systematic assessment

Limitations and Caveats

The stringent criteria for enrollment, qualification and retention in this trial were highly selective for a certain subpopulation of opioid-dependent individuals.

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: Sandra D. Comer
• Organization: Substance Abuse
• Phone: 646-774-6146
• EMail: sdc10@columbia.edu

Publications of Results:

Comer SD, Sullivan MA, Vosburg SK, Manubay J, Amass L, Cooper ZD, Saccone P, Kleber HD. Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers. Addiction. 2010 Apr;105(4):709-18. doi: 10.1111/j.1360-0443.2009.02843.x. Erratum In: Addiction. 2010 Jul;105(7):1332.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00710385
• Other Study ID Numbers: 5518
• First Submitted: June 11, 2008
• First Posted: July 4, 2008
• Results First Submitted: August 19, 2011
• Results First Posted: December 5, 2016
• Last Update Posted: December 5, 2016