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Behavioral Treatment for Cocaine Dependent Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00914381
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University

Tracking Information
First Submitted Date  ICMJE June 3, 2009
First Posted Date  ICMJE June 5, 2009
Last Update Posted Date March 31, 2020
Study Start Date  ICMJE December 1994
Actual Primary Completion Date March 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Cocaine abstinence [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Reduced HIV risk behavior [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral Treatment for Cocaine Dependent Women
Official Title  ICMJE Behavioral Treatment for Cocaine Dependent Women
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE Behavioral: Behavioral therapy
Study Arms  ICMJE
  • Active Comparator: CRA + CM
    Community Reinforcement Approach (CRA) combined with Contingency Management (CM)
    Intervention: Behavioral: Behavioral therapy
  • Active Comparator: TSF + CM
    Twelve-Step Facilitation (TSF) combined with Contingency Management (CM)
    Intervention: Behavioral: Behavioral therapy
  • Active Comparator: CRA + VC
    Community Reinforcement Approach (CRA) combined with Voucher Control (VC)
    Intervention: Behavioral: Behavioral therapy
  • Active Comparator: TSF + VC
    Twelve-Step Facilitation (TSF) combined with Voucher Control (VC)
    Intervention: Behavioral: Behavioral therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
145
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2002
Actual Primary Completion Date March 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00914381
Other Study ID Numbers  ICMJE 9410007875
R01DA006915 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Schottenfeld, Yale University School of Medicine
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Richard S. Schottenfeld, M.D. Yale University
PRS Account Yale University
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP