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

This study has been completed.
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, Yale University
ClinicalTrials.gov Identifier:
NCT01625767
First received: June 19, 2012
Last updated: August 19, 2013
Last verified: August 2013
  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 Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Tobacco Approach Avoidance Training for Smoking Cessation in Adolescent Smokers-Study 1

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • automatic approach tendencies towards smoking-related stimuli [ Time Frame: at end of AAT at Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Suchitra Krishnan-Sarin, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01625767     History of Changes
Other Study ID Numbers: 1103008127-1
Study First Received: June 19, 2012
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Nicotine
Smoking
Adolescent
Tobacco

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

ClinicalTrials.gov processed this record on October 23, 2014