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

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ClinicalTrials.gov Identifier: NCT01625767
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : August 21, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: AAT experiment Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : September 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: Approach Avoidance Task experiment
Approach Avoidance Task experiment
Behavioral: AAT experiment
Smokers and nonsmokers complete AAT experiment


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria

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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 Posted: June 21, 2012    Key Record Dates
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