Back to resultsTargeted Intervention for Bipolar Smokers
Primary Purpose
Nicotine Dependence, Bipolar Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling/Healthy Lifestyle
Counseling/Managing Mood
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring Smoking, Tobacco, Nicotine, Bipolar
Eligibility 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
Sites / Locations
- The University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Counseling/Mood Management
Counseling/Healthy Lifestyle
Arm 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.
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.
Outcomes
Primary Outcome Measures
Prolonged Abstinence from Smoking
Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.
Secondary Outcome Measures
Prevalence of Abstinence from Smoking
Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit.
Full Information
NCT ID
NCT01550029
First Posted
April 21, 2011
Last Updated
January 3, 2014
Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01550029
Brief Title
Targeted Intervention for Bipolar Smokers
Official Title
Targeted Intervention for Bipolar Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Bipolar Disorder
Keywords
Smoking, Tobacco, Nicotine, Bipolar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Counseling/Mood Management
Arm Type
Experimental
Arm 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.
Arm Title
Counseling/Healthy Lifestyle
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Counseling/Healthy Lifestyle
Other Intervention Name(s)
Behavior therapy
Intervention 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 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
Intervention Name(s)
Counseling/Managing Mood
Other Intervention Name(s)
Behavior Therapy
Intervention 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 managing negative moods without smoking and overcoming other obstacles to quitting.
Primary Outcome Measure Information:
Title
Prolonged Abstinence from Smoking
Description
Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.
Time Frame
Last four weeks of treatment period
Secondary Outcome Measure Information:
Title
Prevalence of Abstinence from Smoking
Description
Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit.
Time Frame
Last 7 days of treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaimee Heffner, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Targeted Intervention for Bipolar Smokers
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