Targeted Intervention for Bipolar Smokers
This trial is active, not recruiting.
|Conditions||nicotine dependence, bipolar disorder|
|Treatments||counseling/healthy lifestyle, counseling/managing mood|
|Sponsor||University of Cincinnati|
|Collaborator||National Institute on Drug Abuse (NIDA)|
|Start date||July 2010|
|End date||August 2014|
|Trial size||50 participants|
|Trial identifier||NCT01550029, 09-09-14-02, 1K23DA026517-01A1|
The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Prolonged Abstinence from Smoking
time frame: Last four weeks of treatment period
Prevalence of Abstinence from Smoking
time frame: Last 7 days of treatment period
Male or female participants at least 18 years old.
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
|Official title||Targeted Intervention for Bipolar Smokers|
|Principal investigator||Jaimee Heffner, MD|
|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.|
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