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Clinical Trials/NCT00914381
NCT00914381
Completed
Phase 2

Behavioral Treatment for Cocaine Dependent Women

Yale University2 sites in 1 country145 target enrollmentDecember 1994

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cocaine Dependence
Sponsor
Yale University
Enrollment
145
Locations
2
Primary Endpoint
Cocaine abstinence
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1994
End Date
March 2002
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cocaine abstinence

Time Frame: 24 weeks

Secondary Outcomes

  • Reduced HIV risk behavior(24 weeks)

Study Sites (2)

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