Behavioral Treatment for Cocaine Dependent Women

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00914381
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 145
• Locations: 2
• Arms: 4
• Duration (Months): 87
• Patients Per Site: 72.5
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Behavioral: Behavioral therapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 145 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Behavioral Treatment for Cocaine Dependent Women
• Study Start Date: Dec 1, 1994
• Actual Primary Completion Date: Mar 1, 2002
• Actual Study Completion Date: Mar 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CRA + CM Community Reinforcement Approach (CRA) combined with Contingency Management (CM)	Behavioral: Behavioral therapy
Active Comparator: TSF + CM Twelve-Step Facilitation (TSF) combined with Contingency Management (CM)	Behavioral: Behavioral therapy
Active Comparator: CRA + VC Community Reinforcement Approach (CRA) combined with Voucher Control (VC)	Behavioral: Behavioral therapy
Active Comparator: TSF + VC Twelve-Step Facilitation (TSF) combined with Voucher Control (VC)	Behavioral: Behavioral therapy

Outcome Measures

Primary Outcome Measures

1. Cocaine abstinence [24 weeks]

Secondary Outcome Measures

1. Reduced HIV risk behavior [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The APT Foundation, Inc. MRU	New Haven	Connecticut	United States	06519
2	Yale University School of Medicine	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Richard S. Schottenfeld, M.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00914381
• Other Study ID Numbers: 9410007875; R01DA006915
• First Posted: Jun 5, 2009
• Last Update Posted: Mar 31, 2020
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Community reinforcement approach; Contingency management; 12-step facilitation counseling; Cocaine dependence; Women
• Additional relevant MeSH terms: Cocaine-Related Disorders

Study Results

No Results Posted as of Mar 31, 2020