Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

Opioid-Related Disorders Clinical Trial

Official title:

Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218101
• Other study ID #: NIDA-09262-11
• Secondary ID: P50-09262-11DPMC
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 11, 2017
• Start date: May 2004
• Est. completion date: March 2005

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use
Primary	medication compliance
Primary	treatment retention
Secondary	Behavioral and psychological measures (measured during the dose reduction phase)