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Targeted Intervention for Bipolar Smokers


N/A
18 Years
N/A
Open (Enrolling)
Both
Nicotine Dependence, Bipolar Disorder

Thank you

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 CincinnatiCincinnati, Ohio  452219