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Completed

NCT Number: NCT01625767

Tobacco Approach Avoidance Training for Adolescent Smokers-1

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.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University, School of Medicine, Dpeartment of Psychiatry

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AAT experiment

Behavioral

Smokers and nonsmokers complete AAT experiment

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • VU University of Amsterdam

Registry information

Official study title

Tobacco Approach Avoidance Training for Smoking Cessation in Adolescent Smokers-Study 1

Acronym: AAT-1

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 21, 2012
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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