Opioid Maintenance Medications Comparison Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

1998-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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LAAM. buprenorphine and methadone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Rolley E Johnson, PharmD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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. doi: 10.1056/NEJM200011023431802.

Reference Type RESULT

PMID: 11058673 (View on PubMed)

Other Identifiers

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BPR-95-07-24-03

Identifier Type: -

Identifier Source: org_study_id