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

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AAT-experiment
AAT-placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Nicotine, Smoking, Adolescent, Tobacco

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale University, School of Medicine, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AAT-avoid cigarette condition

AAT-no contingency continued assessment

Arm Description

Adolescent smokers are trained to avoid tobacco in a training AAT

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2012
Last Updated
January 17, 2014
Sponsor
Yale University
Collaborators
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT01625637
Brief Title
Tobacco Approach Avoidance Training for Adolescent Smokers-2
Acronym
AAT-2
Official Title
Tobacco Approach Avoidance Training for A Smoking Cessation in Adolescent Smokers- Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
VU University of Amsterdam

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Nicotine, Smoking, Adolescent, Tobacco

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AAT-avoid cigarette condition
Arm Type
Experimental
Arm Description
Adolescent smokers are trained to avoid tobacco in a training AAT
Arm Title
AAT-no contingency continued assessment
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
AAT-experiment
Intervention Description
This AAT condition trains kids to avoid cigarettes
Intervention Type
Behavioral
Intervention Name(s)
AAT-placebo
Intervention Description
This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).
Primary Outcome Measure Information:
Title
Number of cigarettes smoked
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suchitra Krishnan-Sarin, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University, School of Medicine, Department of Psychiatry
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Tobacco Approach Avoidance Training for Adolescent Smokers-2

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