Tobacco Approach Avoidance Training for Adolescent Smokers-1 - Full Text View

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:

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth

U.S. FDA Resources

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.

Estimated Enrollment:	40
Study Start Date:	September 2011
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	June 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

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:

Related Info This link exits the ClinicalTrials.gov site

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:	June 20, 2012
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
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013

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