Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders
Intervention: Buprenorphine (Drug)
Phase: N/A
Status: Terminated
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Eric C. Strain, MD, Principal Investigator, Affiliation: Johns Hopkins University
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.
Clinical Details
Official title: Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Physiological effectsAnalog rating scale for drug effects
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Meets criteria for opioid dependence
Exclusion Criteria:
- Significant medical or psychiatric illness
Locations and Contacts
Johns Hopkins University (BPRU) Bayview Campus, Baltimore, Maryland 21224 6823, United States
Additional Information
Starting date: September 2002
Ending date: January 2004
Last updated: March 15, 2007
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