Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
|ClinicalTrials.gov Identifier: NCT01442493|
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : September 18, 2017
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Opiate Dependence||Other: Patient-Centered Methadone Treatment Other: Methadone Treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|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|
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.
- Number of Participants With Opiate Positive Urine Tests [ Time Frame: 12-months post-baseline ]Number of participants with opiate positive urine tests
- Number of Participants With Cocaine Positive Urine Tests [ Time Frame: 12-months post-baseline ]Cocaine positive urine drug test
- 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.
- Criminal Behavior [ Time Frame: 12-months post-baseline ]Days of criminal behavior
- 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.
- 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
- Number of Participants Meeting DSM-IV Cocaine Dependence Criteria [ Time Frame: 12-months post-baseline ]Number of participants meeting DSM-IV cocaine dependence criteria
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Robert P Schwartz, M.D.||Friends Research Institute, Inc.|