Nicotine DependenceEarly Phase 1SOARRNCT07007195
Smart Olfaction App to Reduce Relapse
A Early Phase 1 study testing Ad Libitum Use followed by Instructed Use of the Inspire Device, Instructed Use followed by Ad Libitum Use of the Inspire Device and Smart-T Smoking Cessation App with the Inspire Device Condition in people with Nicotine Dependence, run by University of Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Ad Libitum Use followed by Instructed Use of the Inspire Device, Instructed Use followed by Ad Libitum Use of the Inspire Device and Smart-T Smoking Cessation App with the Inspire Device Condition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2026to 31 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment
Houston, Texas, 77204
Lorra Garey, Ph.D., 713-743-8056, llgarey@central.uh.edu
About this study
Official title: An Innovative Digitally-Delivered Olfactory Method for Reducing Cigarette Cravings and Supporting Smoking Cessation
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.
Read the detailed 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.
- Conditions
- Nicotine Dependence
- Being tested
- Ad Libitum Use followed by Instructed Use of the Inspire Device, Instructed Use followed by Ad Libitum Use of the Inspire Device, Smart-T Smoking Cessation App with the Inspire Device Condition, Smart-T Smoking Cessation App Without the Inspire Device Condition, Nicotine replacement therapy (NRT)
- Keywords
- Substance-Related Disorders, Smoking Cessation, Smartphone-Based Smoking Cessation, Nicotine Dependence
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad Libitum Use followed by Instructed Use of the Inspire DeviceDevice
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™.
Instructed Use followed by Ad Libitum Use of the Inspire DeviceDevice
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™.
Smart-T Smoking Cessation App with the Inspire Device ConditionDevice
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.
Smart-T Smoking Cessation App Without the Inspire Device ConditionDevice
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.
Nicotine replacement therapy (NRT)Drug
NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
Inspire DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Ad Libitum followed by Instructed Use of the Inspire Device | Experimental | Not described Receives: Device: Ad Libitum Use followed by Instructed Use of the Inspire Device; Drug: Nicotine replacement therapy (NRT); Device: Inspire Device |
| Phase I: Instructed Use followed by Ad Libitum Use of the Inspire Device | Experimental | Not described Receives: Device: Instructed Use followed by Ad Libitum Use of the Inspire Device; Drug: Nicotine replacement therapy (NRT); Device: Inspire Device |
| Phase II: Smart-T app + NRT + Inspire | Experimental | Not described Receives: Device: Smart-T Smoking Cessation App with the Inspire Device Condition; Drug: Nicotine replacement therapy (NRT); Device: Inspire Device |
| Phase II: Smart-T + NRT | Active comparator | Not described Receives: Device: Smart-T Smoking Cessation App Without the Inspire Device Condition; Drug: Nicotine replacement therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDS Use
Descriptive data regarding use times and frequency will be assessed.
Measured: Phase I: Post randomization to End of Study (14 days post-quit date)
Odor Assessment
Reports of odor assessment will be used to determine if sniffing specific odors reduce craving more than an odor blank.
Measured: Phase I: Post randomization to End of Study (14 days post-quit date)
Craving Reduction
Participants will report craving levels multiple times per day via the app. Reduction in craving levels over time will be analyzed.
Measured: 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)
Device Acceptability
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.
Measured: Phase I: End of Study (14 days post-quit date). Phase II: End of Study (12 weeks post-quit date)
Smoking Abstinence
Biochemically confirmed 7-day point prevalence abstinence 12 weeks following the scheduled quit day.
Measured: Phase II: Randomization to End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start22 Apr 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over assignment (Phase I) and Parallel assignment (Phase II)
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Oklahoma, Brown University
- Responsible party
- Principal investigator, Lorra Garey, University of Houston
- Investigators
- Lorra Garey, Ph.D., Principal investigator, University of HoustonMichael Businelle, Ph.D., Principal investigator, University of Oklahoma Health SciencesMichael Sayette, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007195
- Sponsor's protocol ID
- STUDY00004387
- Acronym
- SOARR
- Status last verified
- Apr 2026
- First submitted
- 7 May 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Digitally-Delivered Olfactory Method for Reducing Cigarette Cravings and Supporting Smoking Cessation
- ClinicalTrials.gov ID
- NCT07007195
- Acronym / sponsor ID
- SOARR / STUDY00004387
- Conditions
- Nicotine Dependence
- Keywords
- Substance-Related Disorders, Smoking Cessation, Smartphone-Based Smoking Cessation, Nicotine Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- University of Pittsburgh, University of Oklahoma, Brown University
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cross-over assignment (Phase I) and Parallel assignment (Phase II)
| Arm | Type | Receives |
|---|---|---|
| Phase I: Ad Libitum followed by Instructed Use of the Inspire Device | Experimental | Device: Ad Libitum Use followed by Instructed Use of the Inspire Device, Drug: Nicotine replacement therapy (NRT), Device: Inspire Device |
| Phase I: Instructed Use followed by Ad Libitum Use of the Inspire Device | Experimental | Device: Instructed Use followed by Ad Libitum Use of the Inspire Device, Drug: Nicotine replacement therapy (NRT), Device: Inspire Device |
| Phase II: Smart-T app + NRT + Inspire | Experimental | Device: Smart-T Smoking Cessation App with the Inspire Device Condition, Drug: Nicotine replacement therapy (NRT), Device: Inspire Device |
| Phase II: Smart-T + NRT | Active comparator | Device: Smart-T Smoking Cessation App Without the Inspire Device Condition, Drug: Nicotine replacement therapy (NRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad Libitum Use followed by Instructed Use of the Inspire DeviceParticipants 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 | Phase I: Ad Libitum followed by Instructed Use of the Inspire Device |
| Instructed Use followed by Ad Libitum Use of the Inspire DeviceParticipants 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 | Phase I: Instructed Use followed by Ad Libitum Use of the Inspire Device |
| Smart-T Smoking Cessation App with the Inspire Device ConditionSmart-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 | Phase II: Smart-T app + NRT + Inspire |
| Smart-T Smoking Cessation App Without the Inspire Device ConditionSmart-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. | Device | Phase II: Smart-T + NRT |
| Nicotine replacement therapy (NRT)NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts. | Drug | Phase I: Ad Libitum followed by Instructed Use of the Inspire Device, Phase I: Instructed Use followed by Ad Libitum Use of the Inspire Device, Phase II: Smart-T + NRT, Phase II: Smart-T app + NRT + Inspire |
| Inspire DeviceThe 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. | Device | Phase I: Ad Libitum followed by Instructed Use of the Inspire Device, Phase I: Instructed Use followed by Ad Libitum Use of the Inspire Device, Phase II: Smart-T app + NRT + Inspire |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorra Garey, Ph.D. principal investigator
University of Houston
Michael Businelle, Ph.D. principal investigator
University of Oklahoma Health Sciences
Michael Sayette, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ad Libitum Use followed by Instructed Use of the Inspire Device, Instructed Use followed by Ad Libitum Use of the Inspire Device and Smart-T Smoking Cessation App with the Inspire Device Condition in people with Nicotine Dependence, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorra Garey, Ph.D. (713-743-8056, llgarey@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDS Use (time frame: Phase I: Post randomization to End of Study (14 days post-quit date)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.