Tobacco Approach Avoidance Training for Adolescent Smokers-1

NCT01625767 | Completed Phase 2 DMC

• 1 other identifier: 1103008127-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

Nicotine; Smoking; Adolescent; Tobacco

Outcome Measures

Primary Outcomes (5)

• 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.

  at end of AAT at Day 1

• 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.

  at end of AAT at Day 8

• 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.

  at end of AAT at Day 15

• 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.

  at end of AAT at Day 22

• 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.

  at end of AAT at Day 29

Study Arms (1)

Approach Avoidance Task experiment

EXPERIMENTAL

Approach Avoidance Task experiment

Behavioral: AAT experiment

Interventions

AAT experiment BEHAVIORAL

Smokers and nonsmokers complete AAT experiment

Approach Avoidance Task experiment

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, Dpeartment of Psychiatry

New Haven, Connecticut, 06519, United States

Location

Related Links

• Related Info

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: NA
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

US (1)