Overview

This trial is active, not recruiting.

Conditions nicotine dependence, bipolar disorder
Treatments counseling/healthy lifestyle, counseling/managing mood
Sponsor University of Cincinnati
Collaborator National Institute on Drug Abuse (NIDA)
Start date July 2010
End date August 2014
Trial size 50 participants
Trial identifier NCT01550029, 09-09-14-02, 1K23DA026517-01A1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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/managing mood Behavior Therapy
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 managing negative moods without smoking and overcoming other obstacles to quitting.
(Active Comparator)
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.
counseling/healthy lifestyle Behavior therapy
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 develop knowledge and skills for quitting. Also, the National Cancer Institute's "Clearing the Air" guide to smoking cessation will be given to subjects. 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 for establishing a healthier lifestyle.

Primary Outcomes

Measure
Prolonged Abstinence from Smoking
time frame: Last four weeks of treatment period

Secondary Outcomes

Measure
Prevalence of Abstinence from Smoking
time frame: Last 7 days of treatment period

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Targeted Intervention for Bipolar Smokers
Principal investigator Jaimee Heffner, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Cincinnati.