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Completed

NCT Number: NCT01442493

Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

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.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institutes for Behavior Resources REACH, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • opiate dependence
  • newly admitted to methadone treatment

Exclusion criteria

  • pregnancy

Treatment and study plan

Patient-Centered Methadone Treatment

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

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.

Primary outcomes

  1. Number of Participants With Opiate Positive Urine Tests

    Time frame: 12-months post-baseline

    Number of participants with opiate positive urine tests

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Registry information

Official study title

Reengineering Methadone Treatment: A Randomized Clinical Trial

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 28, 2011
Registry last updated
Dec 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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