Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00712036
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : January 9, 2015
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.

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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Behavioral: Interim Behavioral: Comprehensive Behavioral: Restored Not Applicable

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  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Entry Into Comprehensive Methadone Treatment Via Interim Maintenance
Study Start Date : June 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Opioid positive drug tests [ Time Frame: 4 and 12 months post-baseline ]

Secondary Outcome Measures :
  1. HIV risk behavior [ Time Frame: 4 and 12 months post-baseline ]
  2. Treatment Retention [ Time Frame: 4 and 12 months post-baselin ]
  3. Cost-benefit [ Time Frame: 12 months post-baseline ]
  4. Cocaine positive tests [ Time Frame: 4 and 12 months post-baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00712036

United States, Maryland
Friends Research Institute
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
Principal Investigator: Robert P Schwartz, M.D. Friends Research Institute, Inc.

Publications of Results:
Other Publications:
Responsible Party: Friends Research Institute, Inc. Identifier: NCT00712036     History of Changes
Other Study ID Numbers: DA R01 13636
R01DA013636 ( U.S. NIH Grant/Contract )
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Friends Research Institute, Inc.:
Heroin dependence
Interim Methadone Treatment

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents