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Completed

NCT Number: NCT02002858

Smoking Cessation for Depression and Anxiety Treatment

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.

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Key information

Conditions

Smoking Anxiety Disorders Behavior Behavioral Symptoms Consciousness Disorders Depression Depression Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic

Houston, Texas, 77201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

Drug

Depression and Anxiety Smoking Cessation Treatment

Behavioral

Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies

Other names: SDAT

Educational-Support Psychotherapy

Behavioral

Educational-based psychotherapy and standard smoking cessation treatment program

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Integrated Smoking Cessation Treatment for Emotional Dysregulation

Acronym: SDAT

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 6, 2013
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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