NCT00494728Active, not recruitingPhase 1/2
Smoking Cessation for Depressed Smokers
Smoking Cessation Intervention for Depressed Smokers: Treatment Development
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- First submitted
- 28 Jun 2007
- Start date
- 28 Jun 2007
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Depression
- NCT number
- NCT00494728
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 91
- From 28 Jun 2007 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of nicotine replacement therapy
Other illness
- History of psychotic or bipolar disorder
- Current principal DSM-IV Axis I disorder other than unipolar depression or nicotine dependence
- 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
- 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\) History of current medical condition, or any other factor that, in the judgment of the principal investigator, would likely preclude completion of study requirements.
Other
- Current psychotherapy
- Current use of antidepressant
- Involvement in any smoking cessation activities
- Known health or other complications that would adversely affect attendance
- Currently at severe or extreme risk of suicide or moderate risk with resolved plans and preparation
Who the study is looking for
- 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.
- Score greater than or equal to 8 on the PHQ at baseline
- Age greater than or equal to 16
- Smoking greater than or equal to 5 cigarettes per day
- Willing to set a quit date within 6 weeks of baseline
- English speaking and have a telephone
- Willing to attend all sessions
- Willing to provide informed consent and agree to all assessments and study procedures
Age in the registry: 16 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.