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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 Blind (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 ( US NIH Grant/Contract Award Number ) |
| 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 June 28, 2017