Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01442493
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : September 18, 2017
Last Update Posted : December 29, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Other: Patient-Centered Methadone Treatment Other: Methadone Treatment as usual Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reengineering Methadone Treatment: A Randomized Clinical Trial
Study Start Date : September 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Active Comparator: Methadone Treatment as Usual
Methadone treatment provided as usual in the U.S.
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.

Primary Outcome Measures :
  1. Number of Participants With Opiate Positive Urine Tests [ Time Frame: 12-months post-baseline ]
    Number of participants with opiate positive urine tests

Secondary Outcome Measures :
  1. Number of Participants With Cocaine Positive Urine Tests [ Time Frame: 12-months post-baseline ]
    Cocaine positive urine drug test

  2. Drug Use HIV Risk Behavior [ Time Frame: 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.

  3. Criminal Behavior [ Time Frame: 12-months post-baseline ]
    Days of criminal behavior

  4. Global Score on the World Health Organization Quality of Life Measure [ Time Frame: 12-months post-baseline ]
    Scale from 1 through 5. A higher score reflects a better quality of life.

  5. Number of Participants Meeting DSM-IV Opiate Dependence Criteria [ Time Frame: 12-months post-baseline ]
    Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence

  6. Number of Participants Meeting DSM-IV Cocaine Dependence Criteria [ Time Frame: 12-months post-baseline ]
    Number of participants meeting DSM-IV cocaine dependence criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • opiate dependence
  • newly admitted to methadone treatment

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01442493

United States, Maryland
Institutes for Behavior Resources REACH
Baltimore, Maryland, United States, 21218
University of Maryland Drug Treatment Center
Baltimore, Maryland, United States, 21223
Sponsors and Collaborators
Friends Research Institute, Inc.
Principal Investigator: Robert P Schwartz, M.D. Friends Research Institute, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Friends Research Institute, Inc. Identifier: NCT01442493     History of Changes
Other Study ID Numbers: 2R01DA015842 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2011    Key Record Dates
Results First Posted: September 18, 2017
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Friends Research Institute, Inc.:
Methadone Treatment
Opiate dependence
Services research

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents