Tobacco Approach Avoidance Training for Adolescent Smokers-2 (AAT-2)

January 17, 2014 updated by: Suchitra Krishnan-Sarin, Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University, School of Medicine, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AAT-avoid cigarette condition
Adolescent smokers are trained to avoid tobacco in a training AAT
Behavioral: AAT-experiment
This AAT condition trains kids to avoid cigarettes
Placebo Comparator: AAT-no contingency continued assessment
Behavioral: AAT-placebo
This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cigarettes smoked
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

VU University of Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 21, 2012

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1103008127-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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