UW-CTRI has recently completed 2 studies, with data under analysis for dissemination.
1) Genetically Informed Smoking Cessation Trial. This randomized clinical trial was the first genetic study to look at nicotine-replacement therapy (NRT) vs. varenicline head-to-head, and how participants with different genetics respond to the medications. Led by Li-Shiun Chen with collaboration from UW-CTRI Research Director Dr. Tim Baker and UW-CTRI Director of Clinical Services Dr. Doug Jorenby, the researchers hoped to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. The researchers’ recent work, which suggested that the nicotinic receptor gene CHRNA5 alters the response to NRT, has been replicated in a meta-analysis. This study of 720 smokers used a stratified randomization trial design based on a subject’s pertinent genotype for smoking cessation. Specifically, in Aim 1, researchers determined if CHRNA5 genotype moderates the effect of medication (combination NRT, varenicline, vs. placebo) on abstinence. In Aim 2, researchers determined if CHRNA5 genotype predicts medication adherence and side effects. In Aim 3, researchers incorporated multiple genotypes and other predictors in order to develop a clinical treatment assignment algorithm for cessation success. This work could result in improved physician care of patients who smoke, overall smoking cessation success, and prevention of cancer, heart, and lung disease. Sept. 2014-July 2019, $90,000. Funded by the National Institutes of Health. Li-Shiun Chen, PI. Douglas Jorenby, co-PI.
2) Pilot Study of Practice Quitting Smoking and Paced Cigarette Puffing. One goal of this study was to collect pilot data that could be used to improve study procedures. Another goal was to demonstrate the feasibility and safety of remote monitoring of abstinence and paced puffing among adults who smoke daily and agree to practice quitting 4 times, for up to one full day each time. Procedures to be evaluated and improved included:
- Assessing participant levels of carbon monoxide (CO) remotely with a personal CO-monitor, smartphone app, and video chat.
- Supervising paced puffing and assessing subjective reactions to paced puffing in real time via video chat or phone.
- Verifying adherence to paced-puffing instructions not to inhale. This will be done by assessing change in CO from immediately before to immediately after puffing each of a maximum of three cigarettes per paced-puffing session.
Specific aims were:
- To assess the success of remote monitoring of abstinence by tracking: participant response rates and practice-quitting adherence rates.
- To assess the success of remote monitoring of paced puffing by tracking: the number of paced-puffing trials in which CO increased by 5 or more parts per million and monitoring failure rates (e.g., due to signal loss or other procedural failure). Descriptive data regarding the number of paced puffing trials completed (out of a maximum of three per session), and reasons for discontinuation will be computed as well.
- To refine remote monitoring procedures using qualitative feedback from participants about study technology and procedures.
July 2018-Sept 2018, $3000. Funded by the University of Wisconsin. Dr. Danielle McCarthy, PI.