A Study of Varenicline for Prevention of Relapse to Smoking in Patients With Schizophrenia or Bipolar Disorder
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA
for treatment of nicotine dependence and may be particularly beneficial in smokers with
schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will
be effective for smoking cessation in schizophrenia and in addition, has the potential to be
therapeutic for cognitive dysfunction in this population. In addition, more data is needed to
evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar
disorder.
To assess this possibility, we will evaluate the safety and efficacy of 12 months of
varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the
short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or
bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and
Minnesota into an open, 12-week smoking cessation program that includes varenicline added to
weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of
continuous abstinence during the last 2 weeks of the open intervention will be randomized to
the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of
varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants
will then discontinue study medications and behavioral treatment and enter a 3-month follow
up phase.