Smoking Cessation for Depressed Smokers - Full Text View

Purpose

Primary Objective:

1. 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:

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

Secondary Objectives:

1. To test the hypothesis that depressed smokers who are randomized to the CBASP/ST treatment will show greater improvement in mechanisms hypothesized to mediate the relationship between CBASP/ST treatment and improved smoking outcomes. Specifically, we expect:

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;
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.

Condition	Intervention	Phase
Smoking Depression	Behavioral: Smoking Cessation Treatment Behavioral: Nicotine Replacement Therapy Behavioral: Smoking Cessation Treatment + CBASP	Phase I Phase II

MedlinePlus related topics:

Depression Quitting Smoking Smoking Smoking and Youth

Drug Information available for:

Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

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

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

Primary Outcome Measures:

To develop a treatment to help smokers who are currently experiencing depressive disorders to stop smoking. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	91
Study Start Date:	June 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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. Behavioral: Nicotine Replacement Therapy 21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks. Behavioral: Smoking Cessation Treatment + CBASP 12 60-minute individual sessions of combined standard smoking cessation treatment and CBASP.
2 Smoking Cessation Treatment (ST)	Behavioral: Smoking Cessation Treatment 12 60-minute individual sessions of standard smoking cessation treatment. Behavioral: Nicotine Replacement Therapy 21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks.

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Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

History of psychotic or bipolar disorder
Current psychotherapy
Current use of antidepressant
Current principal DSM-IV Axis I disorder other than unipolar depression or nicotine dependence
Involvement in any smoking cessation activities
Current use of nicotine replacement therapy
Known health or other complications that would adversely affect attendance
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
Currently at severe or extreme risk of suicide or moderate risk with resolved plans and preparation
Medical contraindications for use of nicotine patch, including uncontrolled heart disease, history of severe hypersensitivity to nicotine replacement products, or currently pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494728

Contacts


Contact: Jan Blalock, PhD	713-745-1728

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Jan Blalock, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Jan Blalock, PhD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Jan Blalock, PhD/Associate Professor )
Study ID Numbers:	2006-0351
First Received:	June 28, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00494728
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Nicotine polacrilex

Smoking

Depression

Nicotine

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Behavioral Symptoms

Additional relevant MeSH terms:

Habits

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Agonists

Autonomic Agents

Nicotinic Agonists

Physiological Effects of Drugs

Ganglionic Stimulants

Peripheral Nervous System Agents

Cholinergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Institute of Mental Health (NIMH)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00494728