Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
The investigators' hypothesis is that add-on varenicline will be effective (versus placebo)
in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who
are motivated to quit smoking within four weeks. This primary outcome will be assessed from
randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the
investigators also hypothesize that varenicline will prevent relapse in the subsequent
12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the
effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as
well as its safety for use in stable bipolar patients when used as an add-on treatment for
smoking cessation.
The investigators plan to test these hypotheses by conducting a randomized,
placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed
with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up
with them three months later to evaluate extended abstinence.