Opioid Maintenance Medications Comparison Study

This study has been completed.

First Received: June 26, 2006 No Changes Posted

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00344812

Purpose

A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.

Condition	Intervention	Phase
Opioid Dependence	Drug: LAAM. buprenorphine and methadone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Study retention
Drug use

Secondary Outcome Measures:

Safety

Estimated Enrollment:	220
Study Start Date:	January 1996
Estimated Study Completion Date:	June 1998

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion

age 21 to 55 years
diagnosis of opioid dependence by criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
evidence of recent opioid use on toxicologic screening

Exclusion

serious medical or psychiatric illness requiring long-term medication
positive pregnancy test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344812

Locations

United States, Maryland
Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Rolley E Johnson, PharmD

Johns Hopkins University

More Information

Publications:

Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000 Nov 2;343(18):1290-7.

Study ID Numbers:	BPR-95-07-24-03
Study First Received:	June 26, 2006
Last Updated:	June 26, 2006
ClinicalTrials.gov Identifier:	NCT00344812 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Methadone
Buprenorphine
Narcotic Antagonists
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Buprenorphine
Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 11, 2009