Smart smell app to help adults stop smoking
An Innovative Digitally-Delivered Olfactory Method for Reducing Cigarette Cravings and Supporting Smoking Cessation
EARLY_PHASE1 · University of Houston · NCT07007195
This project will test whether adding a smell-based device to a smartphone quit-smoking app helps adults who smoke reduce cravings and stay quit.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07007195 on ClinicalTrials.gov |
What this trial studies
The trial refines and pilots an olfactory stimulation delivery system (OSDS) used alongside an established smartphone smoking cessation app (Smart-T). Phase I is a 14-day crossover micro-randomized trial with 32 treatment-seeking smokers to compare ad libitum versus instructed odor use and measure short-term craving reduction using five daily ecological momentary assessments (EMAs) and a qualitative interview. Phase II is a randomized controlled trial with 100 participants comparing Smart-T plus nicotine patch versus Smart-T plus nicotine patch and the OSDS over a one-week pre-quit and 12-week post-quit EMA period. Participants must have an Apple or Android smartphone and will complete baseline surveys, daily EMAs, biochemical verification of smoking status, and follow-up assessments.
Who should consider this trial
Good fit: Adults who smoke at least five cigarettes per day, are motivated to quit, have an Apple or Android smartphone with data service, and are willing to use nicotine replacement and study procedures are ideal candidates.
Not a fit: People who cannot smell (anosmia), currently vape, are unwilling to use nicotine replacement or a smartphone app, or who cannot participate via the University of Houston procedures may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the device could reduce cigarette cravings and improve short-term quit rates when used with a smartphone app and nicotine replacement.
How similar studies have performed: Smartphone-based cessation programs and nicotine replacement therapy have evidence of effectiveness, but using targeted olfactory stimulation as an adjunct is a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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 * 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)
Where this trial is running
Houston, Texas
- RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Lorra Garey, Ph.D. — University of Houston
- Study coordinator: Lorra Garey, Ph.D.
- Email: llgarey@central.uh.edu
- Phone: 713-743-8056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nicotine Dependence, Substance-Related Disorders, Smoking Cessation, Smartphone-Based Smoking Cessation