Targeted Intervention for Bipolar Smokers

University of Cincinnati50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nicotine Dependence Bipolar Disorder

Interventions

Counseling/Healthy LifestyleBEHAVIORAL

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.

Counseling/Managing MoodBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Prolonged Abstinence from Smoking

Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.

Time frame: Last four weeks of treatment period

Secondary Outcomes

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.

Time frame: Last 7 days of treatment period

Data from ClinicalTrials.gov

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