Smoking Termination / Anxiety Reduction Treatment (ST/ART) (START)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 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: December 1, 2014
Last verified: December 2014
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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 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 Study Completion Date: | May 2015 |
| 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 |
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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
Contacts
| Contact: Zuzuky Robles, BA | 713-743-8444 | zrobles@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
Additional 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: | December 1, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Houston:
|
anxiety stress smoking cessation |
ClinicalTrials.gov processed this record on March 03, 2015