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Behavioral Treatment for Cocaine Dependent Women

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00914381
First received: June 3, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention Phase
Cocaine Dependence
 Behavioral: Behavioral therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Treatment for Cocaine Dependent Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Cocaine abstinence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduced HIV risk behavior [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: December 1994
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914381

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
The APT Foundation, Inc. MRU
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
  More Information

No publications provided

Responsible Party: Richard Schottenfeld, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00914381     History of Changes
Other Study ID Numbers: DA06915, R01-DA-06915
Study First Received: June 3, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Yale University:
Community reinforcement approach
Contingency management
12-step facilitation counseling
Cocaine dependence
Women

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013