- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01625767
Tobacco Approach Avoidance Training for Adolescent Smokers-1 (AAT-1)
August 19, 2013 updated by: Suchitra Krishnan-Sarin, Yale University
Tobacco Approach Avoidance Training for Smoking Cessation in Adolescent Smokers-Study 1
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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
-
-
Connecticut
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New Haven, Connecticut, United States, 06519
- Yale University, School of Medicine, Dpeartment of Psychiatry
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-
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:
- 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: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Approach Avoidance Task experiment
|
Smokers and nonsmokers complete AAT experiment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
automatic approach tendencies towards smoking-related stimuli
Time Frame: at end of AAT at Day 1
|
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.
|
at end of AAT at Day 1
|
automatic approach tendencies towards smoking-related stimuli
Time Frame: at end of AAT at Day 8
|
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.
|
at end of AAT at Day 8
|
automatic approach tendencies towards smoking-related stimuli
Time Frame: at end of AAT at Day 15
|
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.
|
at end of AAT at Day 15
|
automatic approach tendencies towards smoking-related stimuli
Time Frame: at end of AAT at Day 22
|
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.
|
at end of AAT at Day 22
|
automatic approach tendencies towards smoking-related stimuli
Time Frame: at end of AAT at Day 29
|
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.
|
at end of AAT at Day 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
September 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
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)
August 21, 2013
Last Update Submitted That Met QC Criteria
August 19, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1103008127-1
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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