Behavioral Treatment for Cocaine Dependent Women

NCT ID: NCT00914381

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-12-31

Study Completion Date

2002-03-31

Brief Summary

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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

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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.

Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRA + CM

Community Reinforcement Approach (CRA) combined with Contingency Management (CM)

Group Type ACTIVE_COMPARATOR

Behavioral therapy

Intervention Type BEHAVIORAL

TSF + CM

Twelve-Step Facilitation (TSF) combined with Contingency Management (CM)

Group Type ACTIVE_COMPARATOR

Behavioral therapy

Intervention Type BEHAVIORAL

CRA + VC

Community Reinforcement Approach (CRA) combined with Voucher Control (VC)

Group Type ACTIVE_COMPARATOR

Behavioral therapy

Intervention Type BEHAVIORAL

TSF + VC

Twelve-Step Facilitation (TSF) combined with Voucher Control (VC)

Group Type ACTIVE_COMPARATOR

Behavioral therapy

Intervention Type BEHAVIORAL

Interventions

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Behavioral therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Yale University School of Medicine

Principal Investigators

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Richard S. Schottenfeld, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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The APT Foundation, Inc. MRU

New Haven, Connecticut, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA006915

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9410007875

Identifier Type: -

Identifier Source: org_study_id

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