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

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. Identifier: NCT01625637
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : January 20, 2014
VU University of Amsterdam
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: AAT-experiment Behavioral: AAT-placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Tobacco Approach Avoidance Training for A Smoking Cessation in Adolescent Smokers- Study 2
Study Start Date : May 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AAT-avoid cigarette condition
Adolescent smokers are trained to avoid tobacco in a training AAT
Behavioral: AAT-experiment
This AAT condition trains kids to avoid cigarettes
Placebo Comparator: AAT-no contingency continued assessment Behavioral: AAT-placebo
This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).

Primary Outcome Measures :
  1. Number of cigarettes smoked [ Time Frame: 4 weeks ]
    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.

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01625637

United States, Connecticut
Yale University, School of Medicine, Department of Psychiatry
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
VU University of Amsterdam
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University

Responsible Party: Suchitra Krishnan-Sarin, Associate Professor, Yale University Identifier: NCT01625637     History of Changes
Other Study ID Numbers: 1103008127-2
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: August 2013

Keywords provided by Suchitra Krishnan-Sarin, Yale University:

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders