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Incentive Programs for Female Substance Abusers Who Smoke - 3

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: NCT00064922
Recruitment Status : Completed
First Posted : July 16, 2003
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE July 15, 2003
First Posted Date  ICMJE July 16, 2003
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE January 2002
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incentive Programs for Female Substance Abusers Who Smoke - 3
Official Title  ICMJE Incentive Programs for Female Substance Abusers Who Smoke
Brief Summary The purpose of this study is to examine the effects of incentive programs for the treatment of nicotine dependence in women who have problems with substance dependence.
Detailed Description This study will determine the influence of voucher-based CM on reducing smoking (and other drug) use during pregnancy or in post-partum women with children under 1 year of age living with them, or in non-pregnant females who smoke. We are targeting smoking cessation since cigarette use is so prevalent in our service. We will compare a control group to two different voucher-based contingent-reinforcement procedures: one that targets smoking abstinence alone vs. one that offers additional incentives for negative BAL and urinalysis results.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE Behavioral: Behavior Therapy
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
90
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant and or post-partum with at least one child under 1 year old living with them, or non-pregnant, non-post-partum females or previous participant in this study protocol
  • Nicotine Dependent as confirmed by DSM-IV checklist
  • Current cigarette smoker
  • Breath CO reading of at least 8 ppm at the time of the initial study screening
  • Current client with the Shields for Families (Shields) treatment programs

Exclusion Criteria:

  • Non-smoker
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00064922
Other Study ID Numbers  ICMJE NIDA-13638-3
R01-13638-3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leslie Amass, Ph.D. Los Angeles Treatment Research Center
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date May 2008

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