Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

Phase 2

Completed

• Conditions: Opioid-Related Disorders

• Registration Number: NCT00218101
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is to determine the effectiveness of buprenorphine in treating opioid dependent individuals who abuse opioids that are prescribed for chronic pain.

Detailed Description

Many individuals who take opioids for chronic pain abuse the opioid medication. Buprenorphine is an opioid partial agonist that may be effective in treating individuals who abuse opiate pain medication. The purpose of this study is to compare two buprenorphine dosing regimens in order to determine which regimen is more effective in reducing opiate pain medication use and facilitating successful opioid detoxification.

This study will last 27 weeks. Participants will receive a maintenance dose of 8 mg of buprenorphine for 6 weeks, followed by a dose reduction in 2 mg increments over the course of the following 20 weeks. All participants will attend weekly clinical management sessions for the duration of the study.

Study Timeline

• Study Start: 2004-05
• Study Completion: 2005-03
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Status Verified: 2016-10
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

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

Inclusion Criteria

• Current opioid analgesic dependence
• History of at least 2 years of oral opiate analgesic use
• Prescribed opioids for chronic pain
• Pain episode of at least 6 months duration within the 5 years prior to study entry
• Available for the duration of the study
• Good general health

Exclusion Criteria

• Currently using any illicit substance
• Meets criteria for alcohol dependence
• History of heroin use
• History of opiate replacement therapy, including Levo-Alpha Acetyl Methadol (LAAM) or methadone
• Evidence of current maximal primary pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Substance use
medication compliance
treatment retention

Secondary Outcome Measures

Name	Time	Method
Behavioral and psychological measures (measured during the dose reduction phase)

Trial Locations

Locations (1)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States