Smoking Cessation for Depressed Smokers

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.

Conditions

• Smoking
• Depression

Interventions

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Jan Blalock, PhD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-06-28

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States

Study Locations