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Tobacco Approach Avoidance Training for Adolescent Smokers-2 (AAT-2)

This study has been completed.
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, Yale University
ClinicalTrials.gov Identifier:
NCT01625637
First received: June 19, 2012
Last updated: January 17, 2014
Last verified: August 2013

June 19, 2012
January 17, 2014
May 2012
May 2013   (final data collection date for primary outcome measure)
Number of cigarettes smoked [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To evaluate if retraining automatic approach tendencies towards smoking stimuli, in combination with CBT, enhances an adolescent's ability to quit smoking following 4 weeks of treatment for smoking cessation.
Same as current
Complete list of historical versions of study NCT01625637 on ClinicalTrials.gov Archive Site
Not Provided
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Tobacco Approach Avoidance Training for Adolescent Smokers-2
Tobacco Approach Avoidance Training for A Smoking Cessation in Adolescent Smokers- Study 2

This is a two part study. In Study 2, smokers who want to quit smoking will participate in a 4 week smoking cessation program combining weekly cognitive behavioral therapy (CBT) with weekly regular-AAT or placebo-AAT training. We hypothesize that adolescent smokers will exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco Approach Avoidance Training (AAT) task when compared with nonsmokers and that adolescent smokers who are trained to avoid smoking related stimuli using the AAT will avoid tobacco approach tendencies in the AAT test trials and the Implicit Association Task, when compared to adolescent smokers who are not exposed to AAT training. We also hypothesize that adolescent smokers who are trained to avoid tobacco in a training AAT in combination with CBT will have better abstinence rates compared to those who receive placebo AAT training with CBT.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Tobacco Use Disorder
  • Behavioral: AAT-experiment
    This AAT condition trains kids to avoid cigarettes
  • Behavioral: AAT-placebo
    This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).
  • Experimental: AAT-avoid cigarette condition
    Adolescent smokers are trained to avoid tobacco in a training AAT
    Intervention: Behavioral: AAT-experiment
  • Placebo Comparator: AAT-no contingency continued assessment
    Intervention: Behavioral: AAT-placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
August 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inclusion Criteria:
  • Between ages 13-18 years
  • Able to read and write in English.
  • Smokers: Smoking 5 or more cigarettes daily for at least 6 months; Baseline urine cotinine levels > 500 ng/ml
  • Nonsmokers: Never smokers; Baseline urine cotinine levels < 50 ng/ml

Exclusion Criteria:

  • Current criteria for dependence on another psychoactive substance
  • Current diagnosis of psychosis, major depression or panic disorder
  • Regular use of any psychoactive drugs including anxiolytics and antidepressants unless the medication has been taken consistently for 2 months, is currently being monitored by a physician, and the condition for which the medication is taken is considered to be stable
  • Pregnant or lactating girls, based on self report.
Both
13 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01625637
1103008127-2
Yes
Suchitra Krishnan-Sarin, Yale University
Yale University
VU University of Amsterdam
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
Yale University
August 2013

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