Smoking Termination / Anxiety Reduction Treatment (ST/ART) (START)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Houston
Sponsor:
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: May 8, 2014
Last verified: November 2013
  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 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

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: May 8, 2014
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 July 23, 2014