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Tobacco Approach Avoidance Training for Adolescent Smokers-1 (AAT-1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625767
First Posted: June 21, 2012
Last Update Posted: August 21, 2013
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.
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, Yale University
  Purpose
This is a two part study. Study 1 will compare Approach Avoidance Training (AAT) responses in smokers and nonsmokers in order to confirm that adolescent smokers experience cognitive bias towards tobacco-related stimuli.

Condition Intervention Phase
Tobacco Use Disorder Behavioral: AAT experiment Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Tobacco Approach Avoidance Training for Smoking Cessation in Adolescent Smokers-Study 1

Further study details as provided by Suchitra Krishnan-Sarin, Yale University:

Primary Outcome Measures:
  • automatic approach tendencies towards smoking-related stimuli [ Time Frame: at end of AAT at Day 1 ]
    For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expect that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

  • automatic approach tendencies towards smoking-related stimuli [ Time Frame: at end of AAT at Day 8 ]
    For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

  • automatic approach tendencies towards smoking-related stimuli [ Time Frame: at end of AAT at Day 15 ]
    For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

  • automatic approach tendencies towards smoking-related stimuli [ Time Frame: at end of AAT at Day 22 ]
    For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

  • automatic approach tendencies towards smoking-related stimuli [ Time Frame: at end of AAT at Day 29 ]
    For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.


Enrollment: 40
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Approach Avoidance Task experiment
Approach Avoidance Task experiment
Behavioral: AAT experiment
Smokers and nonsmokers complete AAT experiment

  Eligibility

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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 ClinicalTrials.gov identifier (NCT number): NCT01625767


Locations
United States, Connecticut
Yale University, School of Medicine, Dpeartment 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

Additional Information:
Responsible Party: Suchitra Krishnan-Sarin, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01625767     History of Changes
Other Study ID Numbers: 1103008127-1
First Submitted: June 19, 2012
First Posted: June 21, 2012
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Suchitra Krishnan-Sarin, Yale University:
Nicotine
Smoking
Adolescent
Tobacco

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