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Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone

Not Applicable
Terminated
Conditions
Opioid-Related Disorders
Registration Number
NCT00000243
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Brief Summary

Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.

Detailed Description

Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
16
Inclusion Criteria
  • Meets criteria for opioid dependence
Exclusion Criteria
  • Significant medical or psychiatric illness

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Physiological effects
Analog rating scale for drug effects
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Johns Hopkins University (BPRU) Bayview Campus

🇺🇸

Baltimore, Maryland, United States

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