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OpenTrials
Completed

NCT Number: NCT00914381

Behavioral Treatment for Cocaine Dependent Women

To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent voucher control (VC) for the treatment of cocaine dependent pregnant women or women with young children.

Completed

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The APT Foundation, Inc. MRU, New Haven, Connecticut, United States

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About this study

Subjects were randomly assigned to 1 of 4 treatment groups (CRA+VBRT, CRA+VC, TSF+VBRT, TSF+VC). VBRT voucher value increased for each successive cocaine-free urine sample obtained twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during the last 12 weeks. All subjects earned vouchers for attendance at scheduled twice weekly counseling sessions. Manual-guided CRA and TSF were provided by experienced clinicians.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women meeting DSM IV criteria for cocaine dependence
  • Women meeting DSM IV criteria for cocaine dependence with custody of a young child

Exclusion criteria

  • Opioid dependence
  • Psychosis
  • Severe depression
  • Current treatment with any anti-depressant or anti-psychotic medication
  • Medical instability
  • Inability to understand or read English

Treatment and study plan

Behavioral therapy

Behavioral

Primary outcomes

  1. Cocaine abstinence

    Time frame: 24 weeks

Secondary outcomes

  1. Reduced HIV risk behavior

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
1994
Primary completion
2002
Study completion
2002
First posted
Jun 5, 2009
Registry last updated
Mar 31, 2020

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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