Targeted Intervention for Bipolar Smokers

NCT ID: NCT01550029

Last Updated: 2014-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Nicotine Dependence Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Counseling/Managing Mood

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Counseling/Healthy Lifestyle

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavior therapy Behavior Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaimee Heffner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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The University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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1K23DA026517-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-09-14-02

Identifier Type: -

Identifier Source: org_study_id

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