Behavioral Treatment for Cocaine Dependent Women

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Behavioral: Behavioral therapy

• Registration Number: NCT00914381
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1994-12
• Primary Completion: 2002-03
• Study Completion: 2002-03
• Status Verified: 2009-06
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-05
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
CRA + CM	Behavioral therapy	Community Reinforcement Approach (CRA) combined with Contingency Management (CM)
TSF + VC	Behavioral therapy	Twelve-Step Facilitation (TSF) combined with Voucher Control (VC)
TSF + CM	Behavioral therapy	Twelve-Step Facilitation (TSF) combined with Contingency Management (CM)
CRA + VC	Behavioral therapy	Community Reinforcement Approach (CRA) combined with Voucher Control (VC)

Primary Outcome Measures

Name	Time	Method
Cocaine abstinence	24 weeks

Secondary Outcome Measures

Name	Time	Method
Reduced HIV risk behavior	24 weeks

Trial Locations

Locations (2)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

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