Smoking Termination / Anxiety Reduction Treatment (ST/ART) (START)
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ClinicalTrials.gov Identifier: NCT01789125 |
Recruitment Status
:
Completed
First Posted
: February 11, 2013
Last Update Posted
: July 28, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Anxiety Disorders | Drug: Nicotine Patch Behavioral: Smoking Termination and Anxiety Reduction Treatment Behavioral: Education-Supportive Psychotherapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Augmenting Smoking Cessation With Transdiagnostic CBT for Smokers With Anxiety |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | June 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Smoking Termination and Anxiety Reduction Treatment
Cognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies
|
Drug: Nicotine Patch
Behavioral: Smoking Termination and Anxiety Reduction Treatment
Integrated smoking cessation and anxiety reduction treatment
|
Active Comparator: Educational-Support Psychotherapy
Educational-based psychotherapy and standard smoking cessation treatment program
|
Drug: Nicotine Patch Behavioral: Education-Supportive Psychotherapy |
- Smoking status [ Time Frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day. ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789125
United States, Texas | |
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston | |
Houston, Texas, United States, 77204 |
Principal Investigator: | Michael J Zvolensky, Ph.D. | University of Houston |
Additional Information:
Responsible Party: | Michael J. Zvolensky, Ph.D., Hugh Roy and Lillie Cranz Cullen Distinguished University Professor, University of Houston |
ClinicalTrials.gov Identifier: | NCT01789125 History of Changes |
Other Study ID Numbers: |
1R34DA03131301A1 R34DA031313 ( U.S. NIH Grant/Contract ) |
First Posted: | February 11, 2013 Key Record Dates |
Last Update Posted: | July 28, 2016 |
Last Verified: | July 2016 |
Keywords provided by Michael J. Zvolensky, Ph.D., University of Houston:
anxiety stress smoking cessation |
Additional relevant MeSH terms:
Anxiety Disorders Mental Disorders Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |