Tobacco Approach Avoidance Training for Adolescent Smokers-2

Tobacco Use Disorder Clinical Trial

— AAT-2  

Official title:

Tobacco Approach Avoidance Training for A Smoking Cessation in Adolescent Smokers- Study 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625637
• Other study ID #: 1103008127-2
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2012
• Last updated: January 17, 2014
• Start date: May 2012
• Est. completion date: August 2013

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. In Study 2, smokers who want to quit smoking will participate in a 4 week smoking cessation program combining weekly cognitive behavioral therapy (CBT) with weekly regular-AAT or placebo-AAT training. We hypothesize that adolescent smokers will exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco Approach Avoidance Training (AAT) task when compared with nonsmokers and that adolescent smokers who are trained to avoid smoking related stimuli using the AAT will avoid tobacco approach tendencies in the AAT test trials and the Implicit Association Task, when compared to adolescent smokers who are not exposed to AAT training. We also hypothesize that adolescent smokers who are trained to avoid tobacco in a training AAT in combination with CBT will have better abstinence rates compared to those who receive placebo AAT training with CBT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

Inclusion 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• AAT-experiment
This AAT condition trains kids to avoid cigarettes
• AAT-placebo
This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).

Locations

Country	Name	City	State
United States	Yale University, School of Medicine, Department 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	Number of cigarettes smoked	To evaluate if retraining automatic approach tendencies towards smoking stimuli, in combination with CBT, enhances an adolescent's ability to quit smoking following 4 weeks of treatment for smoking cessation.	4 weeks	No