Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Indivior Inc.
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Heroin; Naloxone

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