Targeted Intervention for Bipolar Smokers

Not Applicable

• Conditions: Nicotine Dependence; Bipolar Disorder

• 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

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