MDACC Study Summary 2006-0351

Study Summary
No. 2006-0351:.......Cancer Prevention......Jan Blalock......Behavioral Science

Study Summary Title



Study Summary Number:	2006-0351

Study Title:	Smoking Cessation Intervention for Depressed Smokers: Treatment Development

Physician

New Patient Referral



Name:	Jan Blalock	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-1728 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Participants will come for approximately 15 sessions. Two additional sessions may be completed depending on whether they choose to partake in the optional procedure and schedule the laboratory session separate from their study visits.

Treatment Agents:	Nicotine Psychosocial	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this behavioral research study is to develop a treatment to help smokers who are currently experiencing depressive disorders to stop smoking. Researchers want to compare the effectiveness of this treatment to standard behavioral smoking treatment that helps smokers to quit combined with education on the health-related effects of smoking.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	06/28/2007

IRB Review and Approval Date:	06/28/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00494728
Study Information on Clinical Trials Registry (clinicaltrials.gov)