Tobacco Use DisorderPhase 2AAT-1NCT01625767
Tobacco Approach Avoidance Training for Adolescent Smokers-1
A Phase 2 study testing AAT experiment in people with Tobacco Use Disorder, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- AAT experiment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University, School of Medicine, Dpeartment of Psychiatry
New Haven, Connecticut, 06519
About this study
Official title: 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- AAT experiment
- Keywords
- Nicotine, Smoking, Adolescent, Tobacco
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAT experimentBehavioural
Smokers and nonsmokers complete AAT experiment
| Study group | Role | What they receive |
|---|---|---|
| Approach Avoidance Task experiment | Experimental | Approach Avoidance Task experiment Receives: Behavioral: AAT experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at end of AAT at Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Principal investigator, Suchitra Krishnan-Sarin, Yale University
- Investigators
- Suchitra Krishnan-Sarin, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625767
- Sponsor's protocol ID
- 1103008127-1
- Acronym
- AAT-1
- Status last verified
- Aug 2013
- First submitted
- 19 Jun 2012
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Approach Avoidance Training for Smoking Cessation in Adolescent Smokers-Study 1
- ClinicalTrials.gov ID
- NCT01625767
- Acronym / sponsor ID
- AAT-1 / 1103008127-1
- Conditions
- Tobacco Use Disorder
- Keywords
- Nicotine, Smoking, Adolescent, Tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Approach Avoidance Task experiment | Experimental | Behavioral: AAT experimentApproach Avoidance Task experiment |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAT experimentSmokers and nonsmokers complete AAT experiment | Behavioural | Approach Avoidance Task experiment |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suchitra Krishnan-Sarin, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AAT experiment in people with Tobacco Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
automatic approach tendencies towards smoking-related stimuli (time frame: at end of AAT at Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.