Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

Study Overview
=================
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.

Official Title
-----------------
Reengineering Methadone Treatment: A Randomized Clinical Trial

Conditions
-----------------
Opiate Dependence

Intervention / Treatment
-----------------
* Other: Patient-Centered Methadone Treatment
* Other: Methadone Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: opiate dependence newly admitted to methadone treatment Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-Centered Methadone Treatment<br>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<br>* 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.<br>|
| Active Comparator: Methadone Treatment as Usual<br>Methadone treatment provided as usual in the U.S. | Other: Methadone Treatment as usual<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Opiate Positive Urine Tests | Number of participants with opiate positive urine tests | 12-months post-baseline | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methadone Treatment, Opiate dependence, Services research