Targeted Intervention for Bipolar Smokers
18 Years
N/A
Both
Nicotine Dependence, Bipolar Disorder
Trial Information
Targeted Intervention for Bipolar Smokers
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Prolonged Abstinence from Smoking
Outcome Description:
Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.
Outcome Time Frame:
Last four weeks of treatment period
Safety Issue:
No
Principal Investigator
Jaimee Heffner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Cincinnati
Authority:
United States: Institutional Review Board
Study ID:
09-09-14-02
NCT ID:
NCT01550029
Start Date:
July 2010
Completion Date:
August 2014
Related Keywords:
- Nicotine Dependence
- Bipolar Disorder
- Smoking
- Tobacco
- Nicotine
- Bipolar
- Bipolar Disorder
- Tobacco Use Disorder
Name | Location |
|---|---|
| The University of Cincinnati | Cincinnati, Ohio 452219 |
