Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Phase 4

Completed

Conditions: Nicotine Dependence
Bipolar Disorder
Schizophrenia
Schizoaffective Disorder

Brief Summary: Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. All smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. All participants will receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication. The major endpoint is the feasibility of combining ACT with the different dosing strategies. Investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Low Dose Varenicline	Varenicline	0.5 mg twice daily with 0.5 mg daily titration over one full week
Standard Dose Varenicline	Varenicline	1.0 mg twice daily with standard titration

Primary Outcome Measures

Name	Time	Method
Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies	Through completion of study, an average of 2 years	Demand for participating (# of participants recruited per month); practicality of study procedures (% participants completing study procedures); acceptability of study procedures (% participants adhering to making a quit attempt within the quit window)

Secondary Outcome Measures