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Completed

NCT Number: NCT00712036

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.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Heroin Dependence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friends Research Institute

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interim

Behavioral

Methadone maintenance with emergency counseling only for up to 4 months

Comprehensive

Behavioral

Methadone treatment with counseling as usual

ReStoreD

Behavioral

Methadone maintenance with counseling provided by a clinician with a lower than usual caseload

Primary outcomes

  1. Opioid positive drug tests

    Time frame: 4 and 12 months post-baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2008
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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