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

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.
ClinicalTrials.gov Identifier: NCT01789125
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Anxiety Disorders Drug: Nicotine Patch Behavioral: Smoking Termination and Anxiety Reduction Treatment Behavioral: Education-Supportive Psychotherapy Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
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
Study Start Date : March 2012
Primary Completion Date : December 2015
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Smoking status [ Time Frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day. ]

Eligibility Criteria

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

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

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)
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 Posted: February 11, 2013    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Michael J. Zvolensky, Ph.D., University of Houston:

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
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