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Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

Primary Purpose

Opioid-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opioid dependence

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas Health Science Center

Outcomes

Primary Outcome Measures

Substance use
medication compliance
treatment retention

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT00218101
Brief Title
Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids
Official Title
Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
opioid dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Primary Outcome Measure Information:
Title
Substance use
Title
medication compliance
Title
treatment retention
Secondary Outcome Measure Information:
Title
Behavioral and psychological measures (measured during the dose reduction phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Grabowski, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

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