Targeted Intervention for Bipolar Smokers

Study Overview
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Brief Summary
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The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.

Detailed Description
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All participants will receive the nicotine patch, an FDA-approved smoking cessation medication, in an open-label fashion. In addition to the nicotine patch, participants will be randomized to receive one of the two types of counseling for smoking cessation. Participants will be in the research study for approximately 18 weeks. The total number of study visits is 15.

Official Title
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Targeted Intervention for Bipolar Smokers

Conditions
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Nicotine Dependence, Bipolar Disorder

Intervention / Treatment
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* Behavioral: Counseling/Healthy Lifestyle
* Behavioral: Counseling/Managing Mood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are motivated to quit smoking Male or female 18 years of age or older Diagnosed with bipolar disorder according to DSM-IV criteria Stable on medication with no significant changes in the last 3 months before enrollment. Smoking 10 cigarettes/day for the past 90 days Exclusion Criteria: Healthy volunteers Patients not meeting the criteria for the diagnosis of Bipolar Disorder according to DSM-IV criteria Not being and being treated with medication for the bipolar disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counseling/Mood Management<br>A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help you develop knowledge and skills that can help you quit. Also, subjects will receive the National Cancer Institute's Clearing the Air guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting. | Behavioral: Counseling/Managing Mood<br>* A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's Clearing the Air guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting.<br>* Other names: Behavior Therapy;|
| Active Comparator: Counseling/Healthy Lifestyle<br>A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's Clearing the Air guide to smoking cessation. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways to establish a healthier lifestyle. | Behavioral: Counseling/Healthy Lifestyle<br>* A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help develop knowledge and skills for quitting. Also, the National Cancer Institute's Clearing the Air guide to smoking cessation will be given to subjects. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways for establishing a healthier lifestyle.<br>* Other names: Behavior therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged Abstinence from Smoking | Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period. | Last four weeks of treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Abstinence from Smoking | Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit. | Last 7 days of treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Tobacco, Nicotine, Bipolar