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NCT00344812 Clinical Trial

Opioid Maintenance Medications Comparison Study

Opioid Dependence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00344812
Other study ID # BPR-95-07-24-03
Secondary ID
Status Completed
Phase Phase 2
First received June 26, 2006
Last updated June 26, 2006
Start date January 1996
Est. completion date June 1998

Study information
Verified date March 2006
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date June 1998
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 55 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• LAAM. buprenorphine and methadone

Locations
Country Name City State
United States Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Study retention
Primary Drug use
Secondary Safety
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