Mackenzie Hosie Quinn1, Anna-Marika Bauer1, Erica N Fox2, Jane Hatzell1, Terumi Randle2, Janelle Purnell1, Tucker Rogers1, Nathaniel Stevens1, Frank Leone3, Chad Achenbach2, E Paul Wileyto4, Stephanie Josephson1, Jackie Gollan2, Rebecca Ashare5, Brian Hitsman2, Robert Schnoll6, Robert Gross7. 1. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. 2. Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America. 3. Pulmonary, Allergy, & Critical Care Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. 4. Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. 5. Department of Psychiatry and Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. 6. Department of Psychiatry and Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: schnoll@pennmedicine.upenn.edu. 7. Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Center for Clinical Epidemiology and Biostatistics, and Division of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.
Abstract
BACKGROUND: Tobacco use is approximately three times more common in people living with HIV (PLWH) than the general population. Moreover, current behavioral and pharmacological smoking cessation interventions are less effective for PLWH, highlighting a need for novel ways to optimize tobacco cessation treatments in this group. Prior research indicates that personalized treatment based on the nicotine metabolite ratio (NMR), a biomarker of nicotine metabolism, and augmenting smoking cessation medication adherence may improve cessation treatment for PLWH. METHODS: In this 2 × 2 factorial design trial, 488 smokers with HIV receive 12 weeks ofsmoking cessation medication along with randomization to 1) tailor the smoking cessation drug to their metabolism or not, and 2) provide additional counseling on smoking cessation medication adherence or not. Those randomized to the pharmacogenetic optimization arm receive varenicline or the nicotine patch based on their NMR (varenicline for fast metabolizers and the nicotine patch for slow metabolizers) and those in the control arm receive varenicline. Those randomized to the experimental adherence counseling arm receive Managed Problem Solving (MAPS) targeting their smoking cessation medication and those in the control arm receive standard counseling. CONCLUSION:PLWH on suppressive antiretroviral therapy who smoke lose more life-years due to tobacco use than to their HIV infection, and have lower response rates to current evidence-based treatments for smoking cessation. Both the NMR tailoring and MAPS interventions have the potential to optimize treatments for tobacco use among this population. If effective, this trial may demonstrate ways to further improve long-term health outcomes for PLWH.
RCT Entities:
BACKGROUND:Tobacco use is approximately three times more common in people living with HIV (PLWH) than the general population. Moreover, current behavioral and pharmacological smoking cessation interventions are less effective for PLWH, highlighting a need for novel ways to optimize tobacco cessation treatments in this group. Prior research indicates that personalized treatment based on the nicotine metabolite ratio (NMR), a biomarker of nicotine metabolism, and augmenting smoking cessation medication adherence may improve cessation treatment for PLWH. METHODS: In this 2 × 2 factorial design trial, 488 smokers with HIV receive 12 weeks of smoking cessation medication along with randomization to 1) tailor the smoking cessation drug to their metabolism or not, and 2) provide additional counseling on smoking cessation medication adherence or not. Those randomized to the pharmacogenetic optimization arm receive varenicline or the nicotine patch based on their NMR (varenicline for fast metabolizers and the nicotine patch for slow metabolizers) and those in the control arm receive varenicline. Those randomized to the experimental adherence counseling arm receive Managed Problem Solving (MAPS) targeting their smoking cessation medication and those in the control arm receive standard counseling. CONCLUSION: PLWH on suppressive antiretroviral therapy who smoke lose more life-years due to tobacco use than to their HIV infection, and have lower response rates to current evidence-based treatments for smoking cessation. Both the NMR tailoring and MAPS interventions have the potential to optimize treatments for tobacco use among this population. If effective, this trial may demonstrate ways to further improve long-term health outcomes for PLWH.