Tobacco Use DisorderPhase 2AAT-2NCT01625637
Tobacco Approach Avoidance Training for Adolescent Smokers-2
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. 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. 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?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2013
- 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, Department of Psychiatry
New Haven, Connecticut, 06519
About this study
Official title: Tobacco Approach Avoidance Training for A Smoking Cessation in Adolescent Smokers- Study 2
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- AAT-experiment, AAT-placebo
- 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
This AAT condition trains kids to avoid cigarettes
AAT-placeboBehavioural
This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).
| Study group | Role | What they receive |
|---|---|---|
| AAT-avoid cigarette condition | Experimental | Adolescent smokers are trained to avoid tobacco in a training AAT Receives: Behavioral: AAT-experiment |
| AAT-no contingency continued assessment | Placebo comparator | Not described Receives: Behavioral: AAT-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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 startMay 2012
- Primary completionMay 2013
- Study completionAug 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 66 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
- NCT01625637
- Sponsor's protocol ID
- 1103008127-2
- Acronym
- AAT-2
- Status last verified
- Aug 2013
- First submitted
- 19 Jun 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Approach Avoidance Training for A Smoking Cessation in Adolescent Smokers- Study 2
- ClinicalTrials.gov ID
- NCT01625637
- Acronym / sponsor ID
- AAT-2 / 1103008127-2
- Conditions
- Tobacco Use Disorder
- Keywords
- Nicotine, Smoking, Adolescent, Tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAT-avoid cigarette condition | Experimental | Behavioral: AAT-experimentAdolescent smokers are trained to avoid tobacco in a training AAT |
| AAT-no contingency continued assessment | Placebo comparator | Behavioral: AAT-placebo |
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-experimentThis AAT condition trains kids to avoid cigarettes | Behavioural | AAT-avoid cigarette condition |
| AAT-placeboThis AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes). | Behavioural | AAT-no contingency continued assessment |
Primary outcome
Number of cigarettes smoked
Time frame: 4 weeks
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.
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 20 Jan 2014.
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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 20 Jan 2014. 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. Some participants in this study may receive a placebo. 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?
Number of cigarettes smoked (time frame: 4 weeks). 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 20 Jan 2014.