Tobacco Approach Avoidance Training for Adolescent Smokers-2

NCT01625637 | Completed Phase 2 DMC

• 1 other identifier: 1103008127-2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

Nicotine; Smoking; Adolescent; Tobacco

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AAT-avoid cigarette condition

EXPERIMENTAL

Adolescent smokers are trained to avoid tobacco in a training AAT

Behavioral: AAT-experiment

AAT-no contingency continued assessment

PLACEBO COMPARATOR

Behavioral: AAT-placebo

Interventions

AAT-experiment BEHAVIORAL

This AAT condition trains kids to avoid cigarettes

AAT-avoid cigarette condition

AAT-placebo BEHAVIORAL

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

AAT-no contingency continued assessment

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• VU University of Amsterdam: collaborator

Study Sites (1)

Yale University, School of Medicine, Department of Psychiatry

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Suchitra Krishnan-Sarin, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 20, 2014

Record last verified: 2013-08

Locations

US (1)