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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01789125
First Posted: February 11, 2013
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michael J. Zvolensky, Ph.D., University of Houston
  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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Submitted: February 8, 2013
First Posted: February 11, 2013
Last Update Posted: July 28, 2016
Last Verified: July 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