Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

Not Applicable

Completed

• Conditions: Opiate Dependence
• Interventions: Other: Patient-Centered Methadone Treatment; Other: Methadone Treatment as usual

• Registration Number: NCT01442493
• Lead Sponsor: Friends Research Institute, Inc.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Primary Completion: 2015-04
• Study Completion: 2015-08
• Results First Submitted: 2017-02-01
• Results First Submitted QC: 2017-06-29
• Results First Posted: 2017-09-18
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• opiate dependence
• newly admitted to methadone treatment

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient-Centered Methadone Treatment	Patient-Centered Methadone Treatment	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.
Methadone Treatment as Usual	Methadone Treatment as usual	Methadone treatment provided as usual in the U.S.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Opiate Positive Urine Tests	12-months post-baseline	Number of participants with opiate positive urine tests

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cocaine Positive Urine Tests	12-months post-baseline	Cocaine positive urine drug test
Drug Use HIV Risk Behavior	12-months post-baseline	HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Criminal Behavior	12-months post-baseline	Days of criminal behavior
Global Score on the World Health Organization Quality of Life Measure	12-months post-baseline	Scale from 1 through 5. A higher score reflects a better quality of life.
Number of Participants Meeting DSM-IV Opiate Dependence Criteria	12-months post-baseline	Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence
Number of Participants Meeting DSM-IV Cocaine Dependence Criteria	12-months post-baseline	Number of participants meeting DSM-IV cocaine dependence criteria

Trial Locations

Locations (2)

Institutes for Behavior Resources REACH; 🇺🇸 Baltimore, Maryland, United States

University of Maryland Drug Treatment Center; 🇺🇸 Baltimore, Maryland, United States