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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
OSDS Use
Timeframe: Phase I: Post randomization to End of Study (14 days post-quit date)
2
Odor Assessment
Timeframe: Phase I: Post randomization to End of Study (14 days post-quit date)
3
Craving Reduction
Timeframe: Phase I: Post randomization to End of Study (14 days post-quit date). Phase II: Post randomization to End of Study (12 weeks post-quit date)
4
Device Acceptability
Timeframe: Phase I: End of Study (14 days post-quit date). Phase II: End of Study (12 weeks post-quit date)
5
Smoking Abstinence
Timeframe: Phase II: Randomization to End of Study