Phase 3
N=17
Abuse Liability of Suboxone Versus Subutex
Opioid-related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00710385 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Drug's Breakpoint — 1200; 10; 1100; 1200 number of clicks on a mouse
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Heroin (Drug); Naloxone (Drug); Low Bup Dose (Drug); High Bup Dose (Drug); Low Bup/Nal Dose (Drug); High Bup/Nal Dose (Drug); Placebo (PCB) (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug's Breakpoint |
1200; 10; 1100; 1200; 300; 750 | — |
| SECONDARY Drug "Liking" |
41.5; 3; 29.8; 42.5; 10.5; 27 | — |
Summary
The study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00710385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.