Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

Not Applicable

Completed

• Conditions: Opioid-Related Disorders

• Registration Number: NCT00134914
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.

Detailed Description

Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to characterize the effects of buprenorphine/naloxone in opioid-dependent individuals.

This study will last 10 weeks. Participants will stay in a residential research unit, and will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions, participants will be randomly assigned to receive either sublingual tablets, intramuscular injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.

Study Timeline

• Study Start: 1996-08
• Primary Completion: 1998-04
• Study Completion: 1998-05
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-25
• Status Verified: 2008-07
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Currently opioid dependent
• In good health, as determined by a pre-participation medical examination
• Seeking and eligible for methadone maintenance or detoxification treatment

Exclusion Criteria

• Significant medical or psychiatric illness, other than drug dependence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
physiologic measures	up to one day
Opioid agonist rating	up to one day
opiate withdrawal	up to one day

Trial Locations

Locations (1)

Johns Hopkins University (BPRU) Bayview Campus; 🇺🇸 Baltimore, Maryland, United States