Targeted Intervention for Bipolar Smokers

University of Cincinnati

Status: Unknown

Conditions: Nicotine Dependence; Bipolar Disorder

Treatments: Behavioral: Counseling/Managing Mood; Behavioral: Counseling/Healthy Lifestyle

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01550029

1K23DA026517-01A1 (U.S. NIH Grant/Contract)

09-09-14-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Counseling/Mood Management

Experimental group

Description:

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.

Treatment:

Behavioral: Counseling/Managing Mood

Counseling/Healthy Lifestyle

Active Comparator group

Description:

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.

Treatment:

Behavioral: Counseling/Healthy Lifestyle