Smart smell app to help adults stop smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.