Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

Study Overview
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Brief Summary
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The purpose of the study is to determine whether one of three levels of counseling intensity will be associated with better treatment outcomes when combined with methadone maintenance treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.

Detailed Description
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Waiting lists for methadone treatment programs persist, and new and more effective approaches for expanding treatment access and improving outcomes for heroin dependent individuals are needed. Recently completed research demonstrated that so-called Interim Methadone Maintenance (i.e., methadone with crisis counseling only, for individuals on waiting lists) was associated with greater entry into methadone treatment, less self-reported heroin and cocaine use, lower rates of opioid-positive drug tests, and lower rates of self-reported crime. The present study will build on this work by comparing three levels of counseling provided with methadone treatment: 1)Interim Methadone Treatment; 2) Comprehensive Methadone Treatment (which is the name for the usual amount of counseling provided, i.e., about once per week) and; 3)Restored Methadone Treatment in which the counselors will have a lower case load and will be able to provide more attention to their patients.

Official Title
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Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

Conditions
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Opiate Dependence

Intervention / Treatment
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* Behavioral: Interim
* Behavioral: Comprehensive
* Behavioral: Restored


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult meets criteria for methadone maintenance unable to gain admission to methadone program within 14 days Exclusion Criteria: pregnant acute medical or psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interim<br>Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists. | Behavioral: Interim<br>* Methadone maintenance with emergency counseling only for up to 4 months<br>|
| Active Comparator: Comprehensive<br>Methadone Treatment provided with counseling as usual. | Behavioral: Comprehensive<br>* Methadone treatment with counseling as usual<br>|
| Active Comparator: Restored<br>Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual. | Behavioral: Restored<br>* Methadone maintenance with counseling provided by a clinician with a lower than usual caseload<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid positive drug tests |  | 4 and 12 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV risk behavior |  | 4 and 12 months post-baseline | 
| Treatment Retention |  | 4 and 12 months post-baselin | 
| Cost-benefit |  | 12 months post-baseline | 
| Cocaine positive tests |  | 4 and 12 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heroin dependence, Interim Methadone Treatment, Counseling