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Smoking Termination / Anxiety Reduction Treatment (ST/ART) (START)
This study has been completed.
Sponsor:
University of Houston
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michael J. Zvolensky, Ph.D., University of Houston
ClinicalTrials.gov Identifier:
NCT01789125
First received: February 8, 2013
Last updated: July 27, 2016
Last verified: July 2016
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Purpose
The primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders. We 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.
| Condition | Intervention | Phase |
|---|---|---|
| Smoking Anxiety Disorders | Drug: Nicotine Patch Behavioral: Smoking Termination and Anxiety Reduction Treatment Behavioral: Education-Supportive Psychotherapy | Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Michael J. Zvolensky, Ph.D., University of Houston:
Primary Outcome Measures:
- Smoking status [ Time Frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day. ]
| Enrollment: | 74 |
| Study Start Date: | March 2012 |
| Study Completion Date: | June 2016 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01789125
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789125
Locations
| United States, Texas | |
| Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston | |
| Houston, Texas, United States, 77204 | |
Sponsors and Collaborators
University of Houston
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Michael J Zvolensky, Ph.D. | University of Houston |
More Information
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 ) |
| Study First Received: | February 8, 2013 |
| Last Updated: | July 27, 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 |
ClinicalTrials.gov processed this record on August 18, 2017