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Tobacco Approach Avoidance Training for Adolescent Smokers-1 (AAT-1)

Primary Purpose

Tobacco Use Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AAT experiment

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:

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, Dpeartment of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Approach Avoidance Task experiment

Arm Description

Approach Avoidance Task experiment

Outcomes

Primary Outcome Measures

automatic approach tendencies towards smoking-related stimuli

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expect that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

automatic approach tendencies towards smoking-related stimuli

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

automatic approach tendencies towards smoking-related stimuli

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

automatic approach tendencies towards smoking-related stimuli

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

automatic approach tendencies towards smoking-related stimuli

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

Secondary Outcome Measures

Full Information

NCT ID

NCT01625767

First Posted

June 19, 2012

Last Updated

August 19, 2013

Sponsor

Yale University

Collaborators

VU University of Amsterdam

1. Study Identification

Unique Protocol Identification Number

NCT01625767

Brief Title

Tobacco Approach Avoidance Training for Adolescent Smokers-1

Acronym

AAT-1

Official Title

Tobacco Approach Avoidance Training for Smoking Cessation in Adolescent Smokers-Study 1

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (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. Study 1 will compare Approach Avoidance Training (AAT) responses in smokers and nonsmokers in order to confirm that adolescent smokers experience cognitive bias towards tobacco-related stimuli.

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

Single Group Assignment

Masking

Care Provider

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Approach Avoidance Task experiment

Arm Type

Experimental

Arm Description

Approach Avoidance Task experiment

Intervention Type

Behavioral

Intervention Name(s)

AAT experiment

Intervention Description

Smokers and nonsmokers complete AAT experiment

Primary Outcome Measure Information:

Title

automatic approach tendencies towards smoking-related stimuli

Description

Time Frame

at end of AAT at Day 1

Title

automatic approach tendencies towards smoking-related stimuli

Description

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

Time Frame

at end of AAT at Day 8

Title

automatic approach tendencies towards smoking-related stimuli

Description

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

Time Frame

at end of AAT at Day 15

Title

automatic approach tendencies towards smoking-related stimuli

Description

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

Time Frame

at end of AAT at Day 22

Title

automatic approach tendencies towards smoking-related stimuli

Description

For all AAT comparisons, the investigators will compare median scores (to minimize influence of outliers) for cigarette approach and cigarette avoid RTs. The difference between these values gives the smoking AAT-scores, which the investigators expect to not differ from zero in the non-smokers (or to show mild avoidance), while it is expected that smokers will be faster to approach than to avoid cigarettes. ANOVA models will be used to compare scores in smokers vs. nonsmokers. Regression analyses will be used to explore the relationships between impulsivity-related measures and AAT responses.

Time Frame

at end of AAT at Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

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, Dpeartment of Psychiatry

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Links:

URL

http://try.yale.edu

Description

Related Info

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