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Smoking Cessation for Depressed Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00494728
First Posted: July 2, 2007
Last Update Posted: May 3, 2017
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 of Mental Health (NIMH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

Objectives:

Primary Aim:

To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment (HE/ST) to:

1. Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence

Secondary Aims:

  1. To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points, compared to depressed smokers in the HE/ST treatment, and;
  2. That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, compared to depressed smokers in the ST treatment.
  3. To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months, and:
  4. To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions, and the relation of these changes to abstinence and depressive symptoms at end of treatment, and 3- and 6-months.

Condition Intervention Phase
Smoking Depression Behavioral: Smoking Cessation Treatment Drug: Nicotine Replacement Therapy Behavioral: CBASP Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Cessation Intervention for Depressed Smokers: Treatment Development

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Abstinence Rates [ Time Frame: Approximately each 12 weeks following end of treatment (about 6 weeks) ]

Estimated Enrollment: 202
Actual Study Start Date: June 2007
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CBASP + ST
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST)
Behavioral: Smoking Cessation Treatment
12 60-minute individual sessions of standard smoking cessation treatment.
Drug: Nicotine Replacement Therapy
21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks.
Behavioral: CBASP
Individual counseling sessions where taught/develop interpersonal and behavioral coping skills to help decrease depression and negative moods, and to increase ability to quit smoking.
Other Name: Cognitive Behavioral Analysis System of Psychotherapy
ST
Smoking Cessation Treatment (ST)
Behavioral: Smoking Cessation Treatment
12 60-minute individual sessions of standard smoking cessation treatment.
Drug: Nicotine Replacement Therapy
21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Currently meeting DSM-IV criteria for major depressive disorder, recurrent; or major depressive disorder, recurrent, in partial remission; or major depressive disorder, single episode with a duration of 2 years or more; or; dysthymic disorder.
  2. Score greater than or equal to 8 on the PHQ at baseline
  3. Age greater than or equal to 16
  4. Smoking greater than or equal to 5 cigarettes per day
  5. Willing to set a quit date within 6 weeks of baseline
  6. English speaking and have a telephone
  7. Willing to attend all sessions
  8. Willing to provide informed consent and agree to all assessments and study procedures

Exclusion Criteria:

  1. History of psychotic or bipolar disorder
  2. Current psychotherapy
  3. Current use of antidepressant
  4. Current principal DSM-IV Axis I disorder other than unipolar depression or nicotine dependence
  5. Involvement in any smoking cessation activities
  6. Current use of nicotine replacement therapy
  7. Known health or other complications that would adversely affect attendance
  8. Severe levels of depressive symptoms, vegetative symptoms, and/or symptoms related to secondary psychiatric disorders that place participant at risk for harm or require immediate treatment
  9. Currently at severe or extreme risk of suicide or moderate risk with resolved plans and preparation
  10. Medical contraindications for use of nicotine patch, including uncontrolled heart disease, history of severe hypersensitivity to nicotine replacement products, or currently pregnant or lactating
  11. 11) History of current medical condition, or any other factor that, in the judgment of the principal investigator, would likely preclude completion of study requirements.
  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): NCT00494728


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jan Blalock, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00494728     History of Changes
Other Study ID Numbers: 2006-0351
NCI-2012-02097 ( Registry Identifier: NCI CTRP )
1R01MH076776-01A1 ( U.S. NIH Grant/Contract )
1R01MH087692 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2007
First Posted: July 2, 2007
Last Update Posted: May 3, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Smoking
Depression
Major Depressive Disorder
Cognitive Behavioral Analysis System of Psychotherapy
Smoking Cessation Treatment
Nicotine Replacement Therapy
Nicotine Patch
CBASP
MDD

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
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