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Clinical Trials/NCT00712036
NCT00712036CompletedNot Applicable

Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

Friends Research Institute, Inc.1 site in 1 country230 target enrollmentStarted: June 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
230
Locations
1
Primary Endpoint
Opioid positive drug tests

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •meets criteria for methadone maintenance
  • •unable to gain admission to methadone program within 14 days

Exclusion Criteria

  • •acute medical or psychiatric illness

Arms & Interventions

Interim

Active Comparator

Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists.

Intervention: Interim (Behavioral)

Comprehensive

Active Comparator

Methadone Treatment provided with counseling as usual.

Intervention: Comprehensive (Behavioral)

Restored

Active Comparator

Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual.

Intervention: Restored (Behavioral)

Outcomes

Primary Outcomes

Opioid positive drug tests

Time Frame: 4 and 12 months post-baseline

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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