Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

This pilot feasibility trial is a Phase IV, 12-week, single center, randomized, double blind, parallel group comparison of low (0.5 mg twice daily with slower titration over one full week) versus standard dose (1.0 mg twice daily with standard titration) varenicline in individuals with DSM-V Bipolar Disorder (BD) or Schizophrenia Spectrum Disorders (SSD) with a 12-week, post-treatment follow-up. The 16 visits after screening (Weeks 0-24) include 11 in-person (with medications dispensed at weeks 0, 2, 4, 6, 8 and 10] and 5 via telephone. Plasma will be obtained at baseline to measure participants' Nicotine Metabolite Ratio (NMR) and to identify slow versus normal nicotine metabolisers. A flexible quit date (between days 8-35) will be employed allowing varenicline preloading to occur prior to the Target Quit Date. Ten sessions of Acceptance & Commitment Therapy (ACT) for smoking cessation will be delivered by trained counselors.

Inclusion criteria

• 18-70 years of age
• Outpatients with a DSM-V diagnosis of Bipolar Disorder or Schizophrenia Spectrum Disorder
• Smoke at least 10 cigarettes per day and have an expired carbon monoxide (CO) breathalyzer of ≥ 10 ppm at screening and baseline visits
• Are motivated to quit smoking
• Have access to a mental health provider

Exclusion criteria

• Females who are pregnant, planning to become pregnant, or lactating
• Test positive for any non-prescribed medications or illicit drugs
• Have made a suicide attempt or engaged in self-mutilatory behavior in the past year
• Meet criteria for another Substance Use Disorder in the past month
• In the investigators' judgement, are either psychiatrically or medically unstable to safely participate
• Are currently using any other form of treatment for smoking cessation