Phase 3
N=27
Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone
Heroin Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01760473 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Drug Self-administration — 350; 255; 223; 113 Clicks on a computer mouse
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intranasal challenge drug (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Self-administration |
350; 255; 223; 113; 2.7; 191 | — |
| SECONDARY SOWS |
3; 3; 3; 3; 5; 3 | — |
Summary
The study is designed to compare the abuse liabilities of intranasal buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. The investigators hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.
Eligibility Criteria
Inclusion Criteria
- 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 opioids in amounts and/or frequencies that meet or exceed those used in the proposed study (e.g., 1-2 bags of heroin per occasion at least twice per day)
- Self-administer IN buprenorphine above placebo levels during the qualification phase (see below)
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
- AST or 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 (NCT01760473). 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.