Overview
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.
Description
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
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
- Did not use electronic cigarette or vaping device in the past 90 days
- 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
- English literacy of 7th grade or higher, as indicated by a score of ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)
- Biochemical verification of smoking status
- Proof of smoking status at enrollment via photo of cigarettes
- Presents a photo ID that matches the information on screener survey
- Willing and able to complete study procedures
- Willing to use NRT and quit smoking for 14 days (Phase I) or willing to use NRT and 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
- Being pregnant, breastfeeding, or planning to become pregnant within the next month
- 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
- Cognitive impairment, verified via a score of ≥ 8 on the Six-Item Cognitive Impairment Test (6-CIT)
