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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

September 16, 2005
August 11, 2008
May 2004
Not Provided
  • Substance use
  • medication compliance
  • treatment retention
Substance use, medication compliance and retention
Complete list of historical versions of study NCT00218101 on ClinicalTrials.gov Archive Site
Behavioral and psychological measures (measured during the dose reduction phase)
Behavioral and psychological measures during dose reduction
Not Provided
Not Provided
 
Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids
Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Opioid-Related Disorders
Drug: Buprenorphine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2005
Not Provided

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
Both
25 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218101
NIDA-09262-11, P50-09262-11, DPMC
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
University of Texas
Principal Investigator: John Grabowski, PhD University of Texas
National Institute on Drug Abuse (NIDA)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP