Targeted Intervention for Bipolar Smokers

Not Applicable

• Conditions: Nicotine Dependence; Bipolar Disorder
• Interventions: Behavioral: Counseling/Managing Mood; Behavioral: Counseling/Healthy Lifestyle

• Registration Number: NCT01550029
• Lead Sponsor: University of Cincinnati

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-07
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counseling/Mood Management	Counseling/Managing Mood	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.
Counseling/Healthy Lifestyle	Counseling/Healthy Lifestyle	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.

Primary Outcome Measures

Name	Time	Method
Prolonged Abstinence from Smoking	Last four weeks of treatment period	Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Abstinence from Smoking	Last 7 days of treatment period	Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit.

Trial Locations

Locations (1)

The University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States