smart olfaction app to reduce relapse

Conditions: Nicotine Dependence

Summary: the proposed project aims to refine and test a novel biobehavioral smoking cessation intervention that integrates the strategic application of olfactory stimulation to reduce cigarette craving with an established smartphone-based smoking cessation application. the specific aims of this study are: (1) refine the design and methodology of our olfactory stimulation delivery system (osds) and (2) compare, in a pilot randomized controlled trial (rct), the effects of a smartphone based app for smoking cessation (smart-t) with and without the osds on smoking cessation outcomes.

the objective of the current trial is to refine a novel biobehavioral smoking cessation intervention that integrates the strategic application of olfactory stimulation to reduce cigarette cravings (olfactory stimulation delivery system; osds) and then to test the osds as an adjunctive support for smoking cessation when integrated with an established smartphone-based smoking cessation application (smart-t). the study will be conducted in two phases. phase i will consist of a crossover, micro-randomized controlled trial to inform methodology for odor administration and examine the effects of osds on craving reduction. treatment-seeking smokers (n=32) will engage in a self-guided quit attempt and use the osds for 14 days. using a crossover randomization design, participants will complete 7 days of ad libitum osds use and 7 days of instructed osds use. participants will complete an initial online pre-screener, an enrollment call, a baseline survey via the app, a randomization call, and 5 daily emas during the study. at the end of phase i, participants will complete a qualitative interview over zoom and a quantitative survey in the app to assess their experiences. phase ii will be a rct in which participants (n=100) will be randomized to either (1) smart-t with a nicotine patch (smart-t) or (2) smart-t with a nicotine patch and osds as an adjunctive feature (smart-t+o). participants will complete a baseline assessment, daily emas for 13 weeks (1-week pre-quit and 12 weeks post-quit), a follow-up assessment at 12 weeks post-quit via the app, and a qualitative interview over zoom. all participants will have access to smart-t intervention materials for smoking cessation. smoking status will be biochemically verified at multiple time points using a carbon monoxide monitor, which will be mailed to participants along with usage instructions.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * ability to read, understand and speak english * currently smoke at least 5 cigarettes daily for one year or longer * do not currently smoke marijuana or currently smoke marijuana but willing to not smoke during the duration of the study * have an active smartphone that is apple or android based * have phone service including a data plan * interested in downloading the study app onto their personal phone * motivated to quit smoking * willing and able to complete study procedures * willing to quit smoking for 14 days (phase i) or willing to quit smoking for 13 weeks (phase ii) exclusion criteria: * olfactory dysfunction including inability to smell, a very weak or distorted sense of smell, or sensitivity to odors * report any allergies or negative reactions to odors/fragranced products * not being fluent in english * being pregnant by self-report * report hypertension that is not under control * have had a heart attack within the past two weeks * those who participated in phase i will not be eligible to participate in phase ii * have a smartphone that is not compatible with the insight mhealth platform * report using electronic cigarette or vaping device in the past 90 days

Keywords: substance-related disorders smoking cessation smartphone-based smoking cessation nicotine dependence