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OpenTrials
Completed

NCT Number: NCT00218101

Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

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.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Health Science Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

Primary outcomes

  1. Substance use

  2. medication compliance

  3. treatment retention

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • University of Texas

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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