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Behavioral Treatment for Cocaine Dependent Women

Primary Purpose

Cocaine Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Behavioral therapy

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Community reinforcement approach, Contingency management, 12-step facilitation counseling, Cocaine dependence, Women

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The APT Foundation, Inc. MRU
Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

CRA + CM

TSF + CM

CRA + VC

TSF + VC

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Cocaine abstinence

Secondary Outcome Measures

Reduced HIV risk behavior

Full Information

NCT ID

NCT00914381

First Posted

June 3, 2009

Last Updated

March 27, 2020

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00914381

Brief Title

Behavioral Treatment for Cocaine Dependent Women

Official Title

Behavioral Treatment for Cocaine Dependent Women

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

December 1994 (undefined)

Primary Completion Date

March 2002 (Actual)

Study Completion Date

March 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

Keywords

Community reinforcement approach, Contingency management, 12-step facilitation counseling, Cocaine dependence, Women

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

145 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CRA + CM

Arm Type

Active Comparator

Arm Description

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

Arm Title

TSF + CM

Arm Type

Active Comparator

Arm Description

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

Arm Title

CRA + VC

Arm Type

Active Comparator

Arm Description

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

Arm Title

TSF + VC

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Behavioral therapy

Primary Outcome Measure Information:

Title

Cocaine abstinence

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Reduced HIV risk behavior

Time Frame

24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard S. Schottenfeld, M.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The APT Foundation, Inc. MRU

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Behavioral Treatment for Cocaine Dependent Women

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