Status:
COMPLETED
Abuse Liability of Suboxone Versus Subutex
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Schering-Plough
Conditions:
Opioid-related Disorders
Eligibility:
All Genders
21-45 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
Drug dependence is a major international public health problem of which opioid dependence, notably involving heroin, is a major component. Opioid dependence affects an estimated 13 million injection d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00710385
Start Date
September 1 2007
End Date
August 1 2008
Last Update
December 5 2016
Active Locations (1)
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1
New York State Psychiatric Institute/Columbia University
New York, New York, United States, 10032