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Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

NCT ID: NCT01442493

Last Updated: 2017-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Opiate Dependence

Keywords

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Methadone Treatment Opiate dependence Services research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Patient-Centered Methadone Treatment

Intervention Type OTHER

Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.

Methadone Treatment as Usual

Methadone treatment provided as usual in the U.S.

Group Type ACTIVE_COMPARATOR

Methadone Treatment as usual

Intervention Type OTHER

Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.

Interventions

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Patient-Centered Methadone Treatment

Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.

Intervention Type OTHER

Methadone Treatment as usual

Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* opiate dependence
* newly admitted to methadone treatment

Exclusion Criteria

* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Friends Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert P Schwartz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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Institutes for Behavior Resources REACH

Baltimore, Maryland, United States

Site Status

University of Maryland Drug Treatment Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1.

Reference Type DERIVED
PMID: 29536342 (View on PubMed)

Other Identifiers

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2R01DA015842

Identifier Type: NIH

Identifier Source: org_study_id

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