Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone
Completed · Phase 3 · Has a placebo group
Conditions studied: Heroin Dependence
In brief
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.
Key facts
- Study ID
- NCT01760473
- Run by
- New York State Psychiatric Institute
- People needed
- 27
- Starts
- 2009-05-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-09-08
Who can join
Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- New York State Psychiatric Institute and Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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