Tobacco Approach Avoidance Training for Adolescent Smokers-1

Tobacco Use Disorder Clinical Trial

— AAT-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625767
• Other study ID #: 1103008127-1
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2012
• Last updated: August 19, 2013
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• AAT experiment
Smokers and nonsmokers complete AAT experiment

Locations

Country	Name	City	State
United States	Yale University, School of Medicine, Dpeartment of Psychiatry	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	VU University of Amsterdam

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	automatic approach tendencies towards smoking-related stimuli	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.	at end of AAT at Day 1	No
Primary	automatic approach tendencies towards smoking-related stimuli	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.	at end of AAT at Day 8	No
Primary	automatic approach tendencies towards smoking-related stimuli	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.	at end of AAT at Day 15	No
Primary	automatic approach tendencies towards smoking-related stimuli	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.	at end of AAT at Day 22	No
Primary	automatic approach tendencies towards smoking-related stimuli	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.	at end of AAT at Day 29	No

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