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Clinical Trials/NCT01442493
NCT01442493CompletedNot Applicable

Reengineering Methadone Treatment: A Randomized Clinical Trial

Friends Research Institute, Inc.4 sites in 1 country300 target enrollmentStarted: September 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
300
Locations
4
Primary Endpoint
Number of Participants With Opiate Positive Urine Tests

Study Overview

Brief Summary

The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.

Detailed Description

Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • opiate dependence
  • newly admitted to methadone treatment

Exclusion Criteria

  • pregnancy

Arms & Interventions

Patient-Centered Methadone Treatment

Experimental

Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.

Intervention: Patient-Centered Methadone Treatment (Other)

Methadone Treatment as Usual

Active Comparator

Methadone treatment provided as usual in the U.S.

Intervention: Methadone Treatment as usual (Other)

Outcomes

Primary Outcomes

Number of Participants With Opiate Positive Urine Tests

Time Frame: 12-months post-baseline

Number of participants with opiate positive urine tests

Secondary Outcomes

  • Number of Participants With Cocaine Positive Urine Tests(12-months post-baseline)
  • Drug Use HIV Risk Behavior(12-months post-baseline)
  • Criminal Behavior(12-months post-baseline)
  • Global Score on the World Health Organization Quality of Life Measure(12-months post-baseline)
  • Number of Participants Meeting DSM-IV Opiate Dependence Criteria(12-months post-baseline)
  • Number of Participants Meeting DSM-IV Cocaine Dependence Criteria(12-months post-baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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