Smoking CessationNCT00387049
Anxiety Sensitivity Program for Smoking Cessation
A study testing Anxiety Sensitivity Program for Smoking Cessation in people with Smoking Cessation, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a smoking cessation intervention for persons who are specifically sensitive to anxiety and anxiety-related bodily sensations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Anxiety Sensitivity Program for Smoking Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Apr 2010
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years old
- Not pregnant
- Regular smoker averaging 10 or more cigarettes per day for at least one year
- Score of 25 or greater on 16-item Anxiety Sensitivity Index
- Motivation to Quit score of 7 or greater (using Readiness to Quit Ladder)
- Not currently using pharmacotherapy for smoking cessation (e.g., Zyban)
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- No use of other tobacco products (e.g., chewing tobacco, cigars)
- No Axis-I or Axis-II diagnoses other than mood or anxiety disorders (intake interview required)
- No suicidal or homicidal ideation
- No current psychotropic medication use
- No evidence of substance abuse or dependence (other than nicotine dependence)
- No history of significant medical conditions (cardiovascular, neurological, etc.)
- Ability to provide informed, written consent (no evidence of limited mental capacity)
- Sufficient command of the English language (able to carry on interview conversation)
- Plan to stay in Burlington VT area for at least next 6 months
Who cannot join
- Not between 18-65 years old
- Pregnant or currently trying to become pregnant
- Regular smoker for less than one year OR smoke less than 10 cigarettes per day
- ASI below cutoff level of 25
- Motivation to Quit score of 6 or less (using Readiness to Quit Ladder)
- Current or recent use of any pharmacotherapy for smoking cessation (e.g., patch, Zyban)
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- Current use of other tobacco products (e.g., chewing tobacco, cigars)
- Axis-I disorders other than anxiety or mood disorders.
- Endorsement of suicidality or homicidal ideation.
- Any current psychotropic medication use (must have stopped at least 1 month prior).
- Any evidence of substance abuse or dependence (other than nicotine dependence)
- Any history of significant medical conditions (cardiovascular, neurological, etc.)
- Inability to provide informed, written consent (evidence of limited mental capacity)
- Insufficient command of the English language (unable to carry on conversation)
- Plan to permanently leave Burlington area anytime during the next 6-12 months
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop and test a smoking cessation intervention for persons who are specifically sensitive to anxiety and anxiety-related bodily sensations.
- Conditions
- Smoking Cessation
- Being tested
- Anxiety Sensitivity Program for Smoking Cessation
- Keywords
- Anxiety Sensitivity
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety Sensitivity Program for Smoking CessationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Anxiety-specific smoking cessation care | Experimental | Not described Receives: Behavioral: Anxiety Sensitivity Program for Smoking Cessation |
| Standard smoking cessation care | Active comparator | Not described Receives: Behavioral: Anxiety Sensitivity Program for Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking status
Measured: 2 weeks post Quit Day
Smoking status
Measured: 4 weeks post Quit Day
Smoking status
Measured: 8 weeks post Quit Day
Smoking status
Measured: 16 weeks post Quit Day
Smoking status
Measured: 24 weeks post Quit Day
Secondary outcomes (1)
Where applicable, length of time from Quit Day to relapse.
Measured: Determined at conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startJan 2005
- Primary completionAug 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Michael J. Zvolensky, Ph.D., Principal investigator, University of Vermont, Department of PsychologyAndrew R. Yartz, Ph.D., Study director, University of Vermont, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387049
- Sponsor's protocol ID
- R01DA018734
- Other IDs
- R01DA018734
- Status last verified
- Oct 2006
- First submitted
- 10 Oct 2006
- Last updated
- 22 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Sensitivity Program for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00387049
- Acronym / sponsor ID
- R01DA018734
- Conditions
- Smoking Cessation
- Keywords
- Anxiety Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Oct 2006 (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.
The purpose of this study is to develop and test a smoking cessation intervention for persons who are specifically sensitive to anxiety and anxiety-related bodily sensations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety-specific smoking cessation care | Experimental | Behavioral: Anxiety Sensitivity Program for Smoking Cessation |
| Standard smoking cessation care | Active comparator | Behavioral: Anxiety Sensitivity Program for Smoking Cessation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged between 18 and 65 years old
- Not pregnant
- Regular smoker averaging 10 or more cigarettes per day for at least one year
- Score of 25 or greater on 16-item Anxiety Sensitivity Index
- Motivation to Quit score of 7 or greater (using Readiness to Quit Ladder)
Key exclusion criteria (15 listed)
- Not between 18-65 years old
- Pregnant or currently trying to become pregnant
- Regular smoker for less than one year OR smoke less than 10 cigarettes per day
- ASI below cutoff level of 25
- Motivation to Quit score of 6 or less (using Readiness to Quit Ladder)
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 |
|---|---|---|
| Anxiety Sensitivity Program for Smoking Cessation | Behavioural | Anxiety-specific smoking cessation care, Standard smoking cessation care |
Primary outcome
Smoking status
Time frame: 2 weeks post Quit Day
Smoking status
Time frame: 4 weeks post Quit Day
Smoking status
Time frame: 8 weeks post Quit Day
Smoking status
Time frame: 16 weeks post Quit Day
Smoking status
Time frame: 24 weeks post Quit Day
1 secondary outcome
Where applicable, length of time from Quit Day to relapse.
Time frame: Determined at conclusion of study
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 22 Oct 2010.
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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.
Michael J. Zvolensky, Ph.D. principal investigator
University of Vermont, Department of Psychology
Andrew R. Yartz, Ph.D. study director
University of Vermont, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety Sensitivity Program for Smoking Cessation in people with Smoking Cessation, run by University of Vermont 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 15 inclusion and 15 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 22 Oct 2010. 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.
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?
Smoking status (time frame: 2 weeks post Quit Day). 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 22 Oct 2010; AzTrials last refreshed its copy on 27 Oct 2026.