Depression Clinical Trial
Official title:
Varenicline for Smoking Cessation in Bipolar Depressed Patients: An Open-Label 12-week Feasibility Trial
Patients with bipolar disorder have one of the highest rates of nicotine dependence and one of the lowest quit rates. Varenicline has been shown in previous trials to be effective for smoking cessation, but has not been studied in subjects with bipolar disorder. This 12-week open label trial will be conducted to assess the feasibility, acceptability, and safety of varenicline in bipolar depressed smokers, given in addition to the subject's primary treatment for bipolar disorder. The primary study hypothesis was that the abstinence rate for bipolar depressed patients will be 50%.
Varenicline, a nicotinic acetylcholine receptor partial agonist, has been shown in two
placebo-controlled trials to be efficacious for smoking cessation. Given the high prevalence
of nicotine dependence in bipolar disorder and the high prevalence of sub-syndromal and
syndromal depressive symptoms in bipolar disorder, this 12-week adjunctive varenicline open
label trial will be conducted to assess the feasibility, acceptability, and safety of
varenicline in bipolar depressed smokers. All subjects will receive individual behavioral
counseling.
Primary hypothesis: the abstinence rate for bipolar depressed patients will be 50%.
Secondary hypothesis: At final visit, bipolar depressed patients who have achieved
remission, defined as a Montgomery Asberg Depression Rating Scale (MADRS) <8, will have a
higher rate of tobacco abstinence than depressed patients who did not achieve remission
(MADRS >/= 8).
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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