Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smoking Cessation for Depression and Anxiety Treatment (SDAT)

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: NCT02002858
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michael J. Zvolensky, Ph.D., University of Houston

Brief Summary:
The primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. 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 and depression management treatment program (SDAT). Both treatments also utilize nicotine replacement therapy.

Condition or disease Intervention/treatment Phase
Smoking Anxiety Disorders Depression Disorders Drug: Nicotine Patch Behavioral: Depression and Anxiety Smoking Cessation Treatment Behavioral: Educational-Support Psychotherapy Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Smoking Cessation Treatment for Emotional Dysregulation
Study Start Date : October 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Depression and Anxiety Smoking Cessation Treatment
Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
Drug: Nicotine Patch
Behavioral: Depression and Anxiety Smoking Cessation Treatment
Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
Other Name: SDAT

Active Comparator: Educational-Support Psychotherapy
Educational-based psychotherapy and standard smoking cessation treatment program
Drug: Nicotine Patch
Behavioral: Educational-Support Psychotherapy
Educational-based psychotherapy and standard smoking cessation treatment program




Primary Outcome Measures :
  1. Smoking Status using the Timeline Follow-Back Assessment [ Time Frame: Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day. ]
    Participants will report the number of cigarettes they consumed everyday since their last visit. The number of cigarettes reported will be used to determine smoking status (e.g., 0 cigarettes reported is abstinent and any cigarettes reported is currently smoking).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
  • Elevated anxiety or depression

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
  • Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression
  • Current or intended participation in a concurrent substance abuse treatment
  • Current non-nicotine substance dependence
  • Insufficient command of English to participate in assessment or treatment

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): NCT02002858


Locations
Layout table for location information
United States, Texas
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic
Houston, Texas, United States, 77201
Sponsors and Collaborators
University of Houston
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Michael J Zvolensky, Ph.D. University of Houston
Additional Information:
Layout table for additonal information
Responsible Party: Michael J. Zvolensky, Ph.D., Hugh Roy and Lillie Cranz Cullen Distinguished University Professor, University of Houston
ClinicalTrials.gov Identifier: NCT02002858    
Other Study ID Numbers: 1R34DA03474101
R34DA034741 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Keywords provided by Michael J. Zvolensky, Ph.D., University of Houston:
smoking
cessation
anxiety
anxious
depression
depressed
smoker
stress
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depression
Depressive Disorder
Anxiety Disorders
Pathologic Processes
Behavioral Symptoms
Mood 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