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Opioid Maintenance Medications Comparison Study

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00344812
First received: June 26, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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:

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013