Bipolar Disorder, Nicotine Dependence
Conditions
Keywords
Smoking, Tobacco, Nicotine, Bipolar
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.
Interventions
BEHAVIORALCounseling/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.
BEHAVIORALCounseling/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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Abstinence from Smoking | Last four weeks of treatment period | Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Abstinence from Smoking | Last 7 days of treatment period | Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit. |
Countries
United States
Outcome results
None listed