Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

This study has been completed.
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218101
First received: September 16, 2005
Last updated: August 11, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Opioid-Related Disorders
Drug: Buprenorphine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Substance use
  • medication compliance
  • treatment retention

Secondary Outcome Measures:
  • Behavioral and psychological measures (measured during the dose reduction phase)

Estimated Enrollment: 10
Study Start Date: May 2004
Estimated Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218101

Locations
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Texas
Investigators
Principal Investigator: John Grabowski, PhD University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00218101     History of Changes
Other Study ID Numbers: NIDA-09262-11, P50-09262-11, DPMC
Study First Received: September 16, 2005
Last Updated: August 11, 2008
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014