Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Mar 25, 2010

Keywords

ClinConnect Summary

Varenicline (VAR) is a α4β2 central nicotinic acetylcholine receptor (nAChR) partial agonist. It is believed to mimic the effect of nicotine by stimulating nAChRs and releasing sufficient dopamine in order to reduce craving and withdrawal effects. In the past two years since the approval of VAR there have been some increasing concerns about this medication, particularly in psychiatric smokers. Besides the typical side effects of nausea and insomnia, it has been associated with treatment-emergent suicidality, aggression, psychosis, and induction of hypomania or mania.

Study Design:

Thirty ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Structured Clinical Interview (SCID) derived DSM-IV diagnoses of Bipolar Disorder (Type I or II), and Nicotine Dependence
• • Young Mania Rating Scale Total Score \<12 at study entry
• • HAM-D 17-Item Score \>5 and \<24 at study entry
• • Fagerstrom Test for Nicotine Dependence (FTND) score of 5 or higher
• • Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent "test"
• • Smoking at least 10 cigarettes per day (confirmed by an expired breath CO level \>10 ppm and a plasma cotinine level \>150 ng/ml at baseline)
• • Be motivated to quit smoking within 30 days of initial evaluation, as assessed by a score of 7 or higher on the Contemplation Ladder assessment tool
• • On a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic)
• • Judged by the study psychiatrists and/or trained psychiatric clinicians to be in remission from active manic, hypomanic, major depressive and psychotic symptoms based on a clinical interview and SCID-IV ≥1 month prior to study enrollment
• Exclusion Criteria:
• • Meet criteria for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment
• • Current evidence by SCID-IV and clinical evaluation of suicidality, homicidality or psychosis
• • Meet DSM-IV criteria for current major depression at the time of baseline evaluation
• • A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to varenicline.
• • Serious medical conditions (i.e. a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities)
• • EKG abnormalities
• • Prescription of Nicotine Replacement Therapies (NRTs) including patches, gum, lozenges or inhalers
• • Prescription of monoamine oxidase inhibitors (MAO-I's) including selegiline or moclobemide
• • Prescription of varenicline
• • Prescription of bupropion SR
• • The presence of manic, mixed manic or hypomanic symptoms in the past one month prior to study enrollment.
• • A lifetime history of antidepressant-induced mania or hypomania
• • A history of suicidal ideation while taking antidepressants