Targeted Intervention for Bipolar Smokers

This study is currently recruiting participants.

Verified March 2012 by University of Cincinnati

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

University of Cincinnati

ClinicalTrials.gov Identifier:

NCT01550029

First received: April 21, 2011

Last updated: March 8, 2012

Last verified: March 2012

History of Changes

Purpose

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

Condition	Intervention
Nicotine Dependence Bipolar Disorder	Behavioral: Counseling/Healthy Lifestyle Behavioral: Counseling/Managing Mood

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Targeted Intervention for Bipolar Smokers

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

Prolonged Abstinence from Smoking [ Time Frame: Last four weeks of treatment period ] [ Designated as safety issue: No ]
Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.

Secondary Outcome Measures:

Prevalence of Abstinence from Smoking [ Time Frame: Last 7 days of treatment period ] [ Designated as safety issue: No ]
Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit.

Estimated Enrollment:	50
Study Start Date:	July 2010
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Counseling/Mood Management 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.	Behavioral: Counseling/Managing Mood 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. Other Name: Behavior Therapy
Active Comparator: Counseling/Healthy Lifestyle 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.	Behavioral: Counseling/Healthy Lifestyle 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. Other Name: Behavior therapy

Arms

Assigned Interventions

Experimental: Counseling/Mood Management

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.

Behavioral: Counseling/Managing Mood

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.

Other Name: Behavior Therapy

Active Comparator: Counseling/Healthy Lifestyle

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.

Behavioral: Counseling/Healthy Lifestyle

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.

Other Name: Behavior therapy

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550029

Locations

United States, Ohio
The University of Cincinnati	Recruiting
Cincinnati, Ohio, United States, 452219
Contact: Lauren Stahl, PhD 513-558-6205 stahlla@ucmail.uc.edu
Principal Investigator: Jaimee Heffner, MD

Sponsors and Collaborators

University of Cincinnati

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Jaimee Heffner, MD

University of Cincinnati

More Information

No publications provided

Responsible Party:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT01550029 History of Changes
Other Study ID Numbers:	09-09-14-02, 1K23DA026517-01A1
Study First Received:	April 21, 2011
Last Updated:	March 8, 2012
Health Authority:	United States: Institutional Review Board United States: Federal Government United States: Food and Drug Administration

Keywords provided by University of Cincinnati:

Smoking
Tobacco
Nicotine
Bipolar

Additional relevant MeSH terms:

Bipolar Disorder
Tobacco Use Disorder
Affective Disorders, Psychotic

Mood Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 19, 2013

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