Behavioral Treatment for Cocaine Dependent Women

Cocaine Dependence Clinical Trial

Official title:

Behavioral Treatment for Cocaine Dependent Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914381
• Other study ID #: 9410007875
• Secondary ID: R01DA006915
• Status: Completed
• Phase: Phase 2
• Start date: December 1994
• Est. completion date: March 2002

Study information

• Verified date: June 2009
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Behavioral:
• Behavioral therapy

Locations

Country	Name	City	State
United States	The APT Foundation, Inc. MRU	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine abstinence		24 weeks
Secondary	Reduced HIV risk behavior		24 weeks