Abuse Liability of Suboxone Versus Subutex
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ClinicalTrials.gov Identifier: NCT00710385 |
Recruitment Status :
Completed
First Posted : July 4, 2008
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
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Condition or disease | Intervention/treatment | Phase |
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Opioid-related Disorders | 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) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Reinforcing Effects of Intravenous Buprenorphine Versus Buprenorphine/Naloxone in Buprenorphine-maintained Intravenous Drug Users (P05207) |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Heroin
Heroin 25 mg. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.
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Drug: Heroin
Heroin (25 mg)
Other Name: Diacetylmorphine |
Active Comparator: Naloxone
Naloxone (NAL) .4 mg. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.
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Drug: Naloxone
.4 mg
Other Name: Naloxone Hydrochloride (HCl) |
Experimental: Low Bup Dose
Combined dosing groups of (4 mg and 8mg of Buprenorphine) for participants who administered a maximum of 8 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.
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Drug: Low Bup Dose
4 and 8 mg
Other Name: Subutex |
Experimental: Low Bup/Nal Dose
Combined dosing groups of (4/1 mg and 8/2mg of Buprenorphine + Naloxone) for participants who administered a maximum of 8 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.
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Drug: Low Bup/Nal Dose
Buprenorphine/Naloxone 4/1 mg, 8/2 mg
Other Name: Suboxone |
Experimental: High Bup Dose
Combined dosing groups of (8mg and 16mg of Bup) for participants who administered a maximum of 16 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.
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Drug: High Bup Dose
8mg and 16 mg
Other Name: Subutex |
Experimental: High Bup/Nal Dose
Combined dosing groups of (8/2mg and 16/4mg of Buprenorphine + Naloxone) for participants who administered a maximum of 16 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.
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Drug: High Bup/Nal Dose
Buprenorphine/Naloxone 8/2 mg, 16/4 mg
Other Name: Suboxone |
Placebo Comparator: Placebo
Intravenous placebo (PCB) administration. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.
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Drug: Placebo (PCB)
Placebo control administration
Other Name: 0 mg |
- Drug's Breakpoint [ Time Frame: Single measurement taken following each of the 7 IV experimental doses ]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
- Drug "Liking" [ Time Frame: Peak (highest) rating obtained following drug administration throughout the entire 3 hr session ]Participant's subjective ratings of how much they "Like" the dose they just received on a scale of 0 -100.
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Ages Eligible for Study: | 21 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Diagnostic and Statistical Manual (DSM) IV criteria for heroin dependence
- No major mood, psychotic, or anxiety disorder
- Physically healthy
- Able to perform study procedures
- 21-45 years of age
- Normal body weight
- Current use of i.v. opioids in amounts and/or frequencies that meet or exceed those used in the proposed study (1-2 bags of heroin per occasion at least twice per day)
- Self-administer at least 4 mg i.v. buprenorphine above placebo levels during the dose run up phase
Exclusion Criteria:
- DSM IV criteria for dependence on drugs other than opioids, nicotine or caffeine
- Participants requesting treatment
- Participants on parole or probation
- Pregnancy or lactation
- Birth, miscarriage or abortion within 6 months
- Current or recent history of significant violent behavior
- Current major Axis I psychopathology, other than opioid dependence (e.g., mood disorder with functional impairment or suicide risk, schizophrenia), that might interfere with ability to participate in the study
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal
- Significant suicide risk
- Current chronic pain
- Sensitivity, allergy, or contraindication to opioids
- Current or recent (past 30 days) physical dependence on or treatment with methadone, buprenorphine, or the buprenorphine/naloxone combination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710385
United States, New York | |
New York State Psychiatric Institute/Columbia University | |
New York, New York, United States, 10032 |
Principal Investigator: | Sandra D Comer, PhD | Columbia University/New York State Psychiatric Institute |
Responsible Party: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00710385 |
Other Study ID Numbers: |
5518 |
First Posted: | July 4, 2008 Key Record Dates |
Results First Posted: | December 5, 2016 |
Last Update Posted: | December 5, 2016 |
Last Verified: | December 2012 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data have been published in a peer-reviewed journal. |
Opioid-Related Disorders Narcotic-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine, Naloxone Drug Combination Buprenorphine Heroin Naloxone |
Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Narcotics Central Nervous System Depressants Analgesics |