Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

January 8, 2015 updated by: Friends Research Institute, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Friends Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friends Research Institute, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Robert P Schwartz, M.D., Friends Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 8, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA R01 13636
  • R01DA013636 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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