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
  Purpose

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 Intervention Phase
Tobacco Use Disorder
Behavioral: AAT-experiment
Behavioral: AAT-placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Tobacco Approach Avoidance Training for A Smoking Cessation in Adolescent Smokers- Study 2

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Enrollment: 66
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01625637

Locations
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
Investigators
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Suchitra Krishnan-Sarin, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01625637     History of Changes
Other Study ID Numbers: 1103008127-2
Study First Received: June 19, 2012
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Nicotine
Smoking
Adolescent
Tobacco

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

ClinicalTrials.gov processed this record on August 28, 2014