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Novel Pharmacotherapy Approaches in Smokers with Serious Mental Illness

Institution: University of California, San Diego
Investigator(s): Robert Anthenelli,
Award Cycle: 2019 (Cycle 29) Grant #: T29IP0379 Award: $498,794
Subject Area: Tobacco-Use Prevention and Cessation
Award Type: High Impact Pilot Award

Initial Award Abstract
Persons with serious mental illness (SMI) such as bipolar disorder or schizophrenia smoke at rates 3 to 4 times higher than the general population and die decades earlier from tobacco-related diseases as a result. Despite having a 30-60% harder time quitting smoking and being more prone to experience mental health-related side effects than non-mentally ill (NMI) smokers when trying to quit using the 1st-line smoking cessation aids, SMI smokers are generally excluded in research trials testing newer treatment strategies that hold promise of possibly reducing side effects and boosting quit rates.

The purpose of this proposal is to pilot test in persons with SMI new cessation strategies that have shown promise in NMI smokers. Specifically, we will test a new genetically-informed precision medicine technique called the nicotine metabolite ratio or NMR that determines how rapidly smokers break down nicotine. The NMR has been found to influence a smoker's response to medication treatment. We will also test different ways to take the medication, varenicline, which has been found to be the most effective single medication available in SMI smokers to help them quit. We will determine whether these novel approaches reduce adverse mental health-related medication effects without compromising the medication’s effectiveness. Finally, we will combine the novel dosing strategies with a promising behavioral intervention called Acceptance and Commitment Therapy or ACT that teaches smokers to better accept the internal discomforts associated with a quit attempt to determine whether that, too, proves feasible and shows trends for improving medication tolerability and quit rates.

The information obtained will shed light as to whether a genetically-influenced biomarker of nicotine clearance, the NMR, affects mental health-related side effect propensity in SMI smokers. It will improve the public health of California by availing this neglected subpopulation of smokers, who are disproportionately affected by tobacco-related disease and death, access to receive state-of-the-art smoking cessation treatment. This pilot feasibility trial is designed to obtain preliminary data for a larger, randomized controlled trial testing combined pharmacological and behavioral interventions that can be disseminated to real-world clinical settings throughout the State of California.