Smoking Cessation for Depressed Smokers

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Nicotine

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.