Abuse Liability of Suboxone Versus Subutex

Completed · Phase 3 · Has a placebo group

Conditions studied: Opioid-related Disorders

In brief

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.

Key facts

Study ID

NCT00710385

Run by

New York State Psychiatric Institute

People needed

19

Starts

2007-09-01

Expected to finish

2008-08-01

Last updated by the study team

2016-12-05

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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
• 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

Where it is running

• New York State Psychiatric Institute/Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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