SmokingPhase 1STARTNCT01789125
Smoking Termination / Anxiety Reduction Treatment (ST/ART)
A Phase 1 study testing Nicotine Patch, Smoking Termination and Anxiety Reduction Treatment and Education-Supportive Psychotherapy in people with Smoking and Anxiety Disorders, run by University of Houston at 1 site in United States.
Trial summary
The primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders. The investigators are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation and anxiety… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking, Anxiety Disorders
- What is being tested?
- Nicotine Patch, Smoking Termination and Anxiety Reduction Treatment and Education-Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2016
- Phase
- Phase 1
- 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
- Ages 18-65 years old
- Capable of providing informed consent
- Willing to attend all study visits and comply with the protocol
- Daily smoker for at least one year
- Currently smoke an average of at least 6 cigarettes per day
- Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale
Who cannot join
- Use of other tobacco products
- Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
- Currently suicidal or high suicide risk
- Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
- Unwilling to cease use of benzodiazepines or other fast-acting anxiolytics
- Concurrent psychotherapy initiated in the past three months, or ongoing anxiety psychotherapy
- Current or intended participation in a concurrent substance abuse treatment
- Insufficient command of English to participate in assessment or treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
Houston, Texas, 77204
About this study
Official title: Augmenting Smoking Cessation With Transdiagnostic CBT for Smokers With Anxiety
The primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders. The investigators are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation and anxiety treatment program (START). Both treatments also utilize nicotine replacement therapy.
Read the detailed description
The chief objective of the proposed study is to develop an integrated standard smoking cessation treatment and transdiagnostic anxiety disorder treatment for smokers with anxiety disorders. The intervention is designed to promote smoking cessation and reduce (a) anxiety symptoms, (b) depression, and (c) the cognitive factor of AS, thereby reducing three notable emotional risk factors of smoking cessation relapse, while at the same time targeting (d) nicotine withdrawal symptoms. The intervention development approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral therapies. During the first year, startup activities will include piloting the integrated intervention on a subset of individuals, soliciting internal and external expert consultant and participant feedback, and development of the final treatment protocol. The goal during this phase of the project will be to establish feasibility of treatment delivery, participant acceptability, and potential for an effect. During the following two years, a pilot two-arm efficacy study will be undertaken. The two arms of the randomized trial (RCT) will be: (a) the integrated smoking cessation treatment, consisting of a standard smoking cessation intervention (i.e., CBT-Smoking + Nicotine Replacement Therapy [NRT]) plus a transdiagnostic CBT for anxiety (Smoking Termination and Anxiety Reduction Treatment; START) or (b) standard smoking cessation intervention (i.e., CBT-Smoking + NRT) plus contact control (ST+CTRL). The primary outcomes will be short- and long-term point prevalence abstinence (PPA) and time to first smoking lapse and relapse. The following specific aims are proposed: 1. To compare, in a pilot RCT, the effects of START vs. ST+CTRL on smoking cessation outcomes: Short- and longterm PPA. The investigators expect that PPA will be higher, both in the short- and longterm, for those in the START condition compared to those in ST+CTRL. Similarly, The investigators expect the rate of decline in abstinence over time to be slower in START than in ST+CTRL Time to first smoking lapse and time to smoking relapse. The investigators expect mean time to first lapse and to relapse to be greater for those in the START compared to those in the ST+CTRL condition. 2. To compare, in a pilot RCT, the effect of START vs. ST+CTRL on the remission of anxiety disorders, anxiety and depressive symptoms, anxiety sensitivity, and nicotine withdrawal symptoms. 3. To explore the mechanisms by which START improves smoking cessation. The investigators expect that: Treatments over time will directly cause changes in abstinence and withdrawal symptoms, AS, anxiety symptoms, depressed mood (i.e., the proposed mediators of change in abstinence); The effect of treatment on anxiety symptoms and depressed mood will be moderated by treatment condition, such that those receiving START will improve more than those receiving ST+CTRL Changes in each mediator over time will lead to improvements in abstinence over time, and decreases in AS over time will lead to improvements in anxiety symptoms and depressed mood over time.
- Conditions
- Smoking, Anxiety Disorders
- Being tested
- Nicotine Patch, Smoking Termination and Anxiety Reduction Treatment, Education-Supportive Psychotherapy
- Keywords
- anxiety, stress, smoking, cessation
- Medical subject headings
- Smoking, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Also called Patch, NRT
Smoking Termination and Anxiety Reduction TreatmentBehavioural
Integrated smoking cessation and anxiety reduction treatment
Education-Supportive PsychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Smoking Termination and Anxiety Reduction Treatment | Active comparator | Cognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies Receives: Drug: Nicotine Patch; Behavioral: Smoking Termination and Anxiety Reduction Treatment |
| Educational-Support Psychotherapy | Active comparator | Educational-based psychotherapy and standard smoking cessation treatment program Receives: Drug: Nicotine Patch; Behavioral: Education-Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short- and long-term point prevalence abstinence
The investigators will ask participants various questions about their abstinence. The investigators will measure the length of time between when treatment ends and when/ if they start smoking again. The unit of measure will be length of time in days.
Measured: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
Secondary outcomes (1)
Time to first smoking lapse and relapse
The investigators will ask participants to record the time (in days) of their first (if any) lapse in smoking and their relapse.
Measured: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael J. Zvolensky, Ph.D., University of Houston
- Investigators
- Michael J Zvolensky, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789125
- Sponsor's protocol ID
- 1R34DA03131301A1
- Other IDs
- R34DA031313
- Acronym
- START
- Status last verified
- Apr 2019
- First submitted
- 8 Feb 2013
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Smoking Cessation With Transdiagnostic CBT for Smokers With Anxiety
- ClinicalTrials.gov ID
- NCT01789125
- Acronym / sponsor ID
- START / 1R34DA03131301A1
- Conditions
- Smoking, Anxiety Disorders
- Keywords
- anxiety, stress, smoking, cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Feb 2013 (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 primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders. The investigators are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation and anxiety treatment program (START). Both treatments also utilize nicotine replacement therapy.
Detailed description
The chief objective of the proposed study is to develop an integrated standard smoking cessation treatment and transdiagnostic anxiety disorder treatment for smokers with anxiety disorders. The intervention is designed to promote smoking cessation and reduce (a) anxiety symptoms, (b) depression, and (c) the cognitive factor of AS, thereby reducing three notable emotional risk factors of smoking cessation relapse, while at the same time targeting (d) nicotine withdrawal symptoms. The intervention development approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral therapies. During the first year, startup activities will include piloting the integrated intervention on a subset of individuals, soliciting internal and external expert consultant and participant feedback, and development of the final treatment protocol. The goal during this phase of the project will be to establish feasibility of treatment delivery, participant acceptability, and potential for an effect. During the following two years, a pilot two-arm efficacy study will be undertaken. The two arms of the randomized trial (RCT) will be: (a) the integrated smoking cessation treatment, consisting of a standard smoking cessation intervention (i.e., CBT-Smoking + Nicotine Replacement Therapy [NRT]) plus a transdiagnostic CBT for anxiety (Smoking Termination and Anxiety Reduction Treatment; START) or (b) standard smoking cessation intervention (i.e., CBT-Smoking + NRT) plus contact control (ST+CTRL). The primary outcomes will be short- and long-term point prevalence abstinence (PPA) and time to first smoking lapse and relapse. The following specific aims are proposed: 1. To compare, in a pilot RCT, the effects of START vs. ST+CTRL on smoking cessation outcomes: Short- and longterm PPA. The investigators expect that PPA will be higher, both in the short- and longterm, for those in the START condition compared to those in ST+CTRL. Similarly, The investigators expect the rate of decline in abstinence over time to be slower in START than in ST+CTRL Time to first smoking lapse and time to smoking relapse. The investigators expect mean time to first lapse and to relapse to be greater for those in the START compared to those in the ST+CTRL condition. 2. To compare, in a pilot RCT, the effect of START vs. ST+CTRL on the remission of anxiety disorders, anxiety and depressive symptoms, anxiety sensitivity, and nicotine withdrawal symptoms. 3. To explore the mechanisms by which START improves smoking cessation. The investigators expect that: Treatments over time will directly cause changes in abstinence and withdrawal symptoms, AS, anxiety symptoms, depressed mood (i.e., the proposed mediators of change in abstinence); The effect of treatment on anxiety symptoms and depressed mood will be moderated by treatment condition, such that those receiving START will improve more than those receiving ST+CTRL Changes in each mediator over time will lead to improvements in abstinence over time, and decreases in AS over time will lead to improvements in anxiety symptoms and depressed mood over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking Termination and Anxiety Reduction Treatment | Active comparator | Drug: Nicotine Patch, Behavioral: Smoking Termination and Anxiety Reduction TreatmentCognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies |
| Educational-Support Psychotherapy | Active comparator | Drug: Nicotine Patch, Behavioral: Education-Supportive PsychotherapyEducational-based psychotherapy and standard smoking cessation treatment program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18-65 years old
- Capable of providing informed consent
- Willing to attend all study visits and comply with the protocol
- Daily smoker for at least one year
- Currently smoke an average of at least 6 cigarettes per day
Key exclusion criteria (8 listed)
- Use of other tobacco products
- Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
- Currently suicidal or high suicide risk
- Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
- Unwilling to cease use of benzodiazepines or other fast-acting anxiolytics
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 |
|---|---|---|
| Nicotine PatchAlso: Patch, NRT | Drug | Educational-Support Psychotherapy, Smoking Termination and Anxiety Reduction Treatment |
| Smoking Termination and Anxiety Reduction TreatmentIntegrated smoking cessation and anxiety reduction treatment | Behavioural | Smoking Termination and Anxiety Reduction Treatment |
| Education-Supportive Psychotherapy | Behavioural | Educational-Support Psychotherapy |
Primary outcome
Short- and long-term point prevalence abstinence
Time frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
The investigators will ask participants various questions about their abstinence. The investigators will measure the length of time between when treatment ends and when/ if they start smoking again. The unit of measure will be length of time in days.
1 secondary outcome
Time to first smoking lapse and relapse
Time frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
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 23 Apr 2019.
- Individual participant dataSharing planned: No. Data will be made available upon request.
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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 Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotine Patch, Smoking Termination and Anxiety Reduction Treatment and Education-Supportive Psychotherapy in people with Smoking and Anxiety Disorders, run by University of Houston 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 6 inclusion and 8 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 23 Apr 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Short- and long-term point prevalence abstinence (time frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.). 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 23 Apr 2019.