Behavioral Treatment for Cocaine Dependent Women

Yale University

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Behavioral: Behavioral therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00914381

9410007875

R01DA006915 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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145 participants in 4 patient groups

CRA + CM

Active Comparator group

Description:

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

Treatment:

Behavioral: Behavioral therapy

TSF + CM

Active Comparator group

Description:

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

Treatment:

Behavioral: Behavioral therapy

CRA + VC

Active Comparator group

Description:

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

Treatment:

Behavioral: Behavioral therapy

TSF + VC

Active Comparator group

Description:

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

Treatment:

Behavioral: Behavioral therapy