Entry Into Comprehensive Methadone Treatment Via Interim Maintenance
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Entry Into Comprehensive Methadone Treatment Via Interim Maintenance|
- Opioid positive drug tests [ Time Frame: 4 and 12 months post-baseline ] [ Designated as safety issue: No ]
- HIV risk behavior [ Time Frame: 4 and 12 months post-baseline ] [ Designated as safety issue: No ]
- Treatment Retention [ Time Frame: 4 and 12 months post-baselin ] [ Designated as safety issue: No ]
- Cost-benefit [ Time Frame: 12 months post-baseline ] [ Designated as safety issue: No ]
- Cocaine positive tests [ Time Frame: 4 and 12 months post-baseline ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Interim
Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists.
Methadone maintenance with emergency counseling only for up to 4 months
Active Comparator: Comprehensive
Methadone Treatment provided with counseling as usual.
Methadone treatment with counseling as usual
Active Comparator: Restored
Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual.
Methadone maintenance with counseling provided by a clinician with a lower than usual caseload
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712036
|United States, Maryland|
|Friends Research Institute|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Robert P Schwartz, M.D.||Friends Research Institute, Inc.|