Tobacco Approach Avoidance Training for Adolescent Smokers-2

NCT ID: NCT01625637

Last Updated: 2014-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-08-31

Brief 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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AAT-avoid cigarette condition

Adolescent smokers are trained to avoid tobacco in a training AAT

Group Type: EXPERIMENTAL

AAT-experiment

Intervention Type: BEHAVIORAL

This AAT condition trains kids to avoid cigarettes

AAT-no contingency continued assessment

Group Type: PLACEBO_COMPARATOR

AAT-placebo

Intervention Type: BEHAVIORAL

This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).

Interventions

AAT-experiment

This AAT condition trains kids to avoid cigarettes

Intervention Type: BEHAVIORAL

AAT-placebo

This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VU University of Amsterdam

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Suchitra Krishnan-Sarin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suchitra Krishnan-Sarin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University, School of Medicine, Department of Psychiatry

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1103008127-2

Identifier Type: -

Identifier Source: org_study_id