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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA026517-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling/Mood Management | 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. |
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| Counseling/Healthy Lifestyle | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling/Healthy Lifestyle | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged Abstinence from Smoking | Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period. | Last four weeks of treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Last 7 days of treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaimee Heffner, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Cincinnati | Cincinnati | Ohio | 452219 | United States |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D001714 | Bipolar Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Counseling/Managing Mood | 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. |
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| D019964 | Mood Disorders |
| D001519 | Behavior |
| D005159 | Health Care Facilities Workforce and Services |
| D011613 | Psychotherapy |