Smoking Termination / Anxiety Reduction Treatment (ST/ART) (START)
This study is currently recruiting participants.
Verified February 2013 by University of Houston
Sponsor:
University of Houston
Collaborator:
Information provided by (Responsible Party):
Michael J. Zvolensky, Ph.D., University of Houston
ClinicalTrials.gov Identifier:
NCT01789125
First received: February 8, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
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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 Behavioral: Standard Smoking Cessation Treatment |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 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. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Primary Completion Date: | February 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 Behavioral: Standard Smoking Cessation Treatment |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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 10 cigarettes per day
- Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale
- Primary anxiety disorder diagnosis
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789125
Contacts
| Contact: Michael J Zvolensky, Ph.D. | 713-743-8056 | mjzvolen@central.uh.edu |
Locations
| United States, Texas | |
| Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston | Recruiting |
| Houston, Texas, United States, 77204 | |
| Principal Investigator: Michael J Zvolensky, Ph.D. | |
Sponsors and Collaborators
University of Houston
Investigators
| Principal Investigator: | Michael J Zvolensky, Ph.D. | University of Houston |
| Principal Investigator: | Peter Norton, Ph.D. | University of Houston |
More Information
No publications provided
| 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 |
| Study First Received: | February 8, 2013 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Houston:
|
anxiety stress smoking cessation |
Additional relevant MeSH terms:
|
Smoking Anxiety Disorders Mental Disorders Habits Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013