NCT07007195 · University of Houston
Smart Olfaction App to Reduce Relapse
(SOARR)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Ad Libitum Use followed by Instructed Use of the Inspire Device
Participants in this condition will use the novel olfactory stimulation delivery system (Inspire), to smell a specific order designed to assist with smoking cessation for 7 days. Participants will then be instructed to record every urge to smoke and report times when they think they might smoke in the smartphone-based smoking cessation app, Insight™. When urges above 0 are reported, the app will instruct participants to use the Inspire device. On day 8, participants will receive a notification on the smartphone-based smoking cessation app, Insight™, to switch to the Instructed Use condition. Participants will then be instructed to use the Inspire device only when participants report a cigarette craving above 0 at each of the surveys prompted from the smartphone-based smoking cessation app, Insight™.
DEVICE
Instructed Use followed by Ad Libitum Use of the Inspire Device
Participants in this condition will use the novel olfactory stimulation delivery system (Inspire), to smell a specific order designed to assist with smoking cessation for 7 days. Participants will be instructed to use the Inspire device only when participants report a cigarette craving above 0 at each of the surveys prompted from the smartphone-based smoking cessation app, Insight™. On day 8, participants will receive a notification on the smartphone-based smoking cessation app, Insight™, to switch to the Ad Libitum condition. Participants will then control how often they use Inspire and will be instructed to record every urge to smoke and report times when they think they might smoke in the smartphone-based smoking cessation app, Insight™.
DEVICE
Smart-T Smoking Cessation App with the Inspire Device Condition
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempts. Smart-T app contains multiple components, including an EMA delivery and data transfer system, automated messages based on EMA responses, and on-demand content. Participants will use Smart-T for 13 weeks. Participants will also use the Inspire device.
DEVICE
Smart-T Smoking Cessation App Without the Inspire Device Condition
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempts. Smart-T app contains multiple components, including an EMA delivery and data transfer system, automated messages based on EMA responses, and on-demand content. Participants will use Smart-T for 13 weeks.
DRUG
Nicotine replacement therapy (NRT)
NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
DEVICE
Inspire Device
The Inspire Device is a novel olfactory stimulation delivery system. It is a self-contained system with seven sealed chambers, with six gel matrix's that contain a distinct odor and one odorless gel matrix. Participants will press a button on the device to release an odor for participants to smell.
Primary outcome measures
OSDS Use
Time frame: Phase I: Post randomization to End of Study (14 days post-quit date)
Descriptive data regarding use times and frequency will be assessed.
Odor Assessment
Time frame: Phase I: Post randomization to End of Study (14 days post-quit date)
Reports of odor assessment will be used to determine if sniffing specific odors reduce craving more than an odor blank.
Craving Reduction
Time frame: 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)
Participants will report craving levels multiple times per day via the app. Reduction in craving levels over time will be analyzed.
Device Acceptability
Time frame: Phase I: End of Study (14 days post-quit date). Phase II: End of Study (12 weeks post-quit date)
Participant satisfaction ratings and qualitative feedback. Acceptability will be assessed through post-intervention surveys and qualitative interviews, focusing on perceived usefulness, ease of use, and overall satisfaction.
Smoking Abstinence
Time frame: Phase II: Randomization to End of Study
Biochemically confirmed 7-day point prevalence abstinence 12 weeks following the scheduled quit day.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Houston, Texas
Collaborators
University of Pittsburgh, University of Oklahoma, Brown University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations