Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
132 participants
INTERVENTIONAL
2025-10-17
2027-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Phase I: Ad Libitum followed by Instructed Use of the Inspire 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 about 0 at each of the surveys prompted from the smartphone-based smoking cessation app, Insight™.
Nicotine replacement therapy (NRT)
NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
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.
Phase I: Instructed Use followed by Ad Libitum Use of the Inspire 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 about 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™.
Nicotine replacement therapy (NRT)
NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
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.
Phase II: Smart-T app + NRT + Inspire
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.
Nicotine replacement therapy (NRT)
NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
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.
Phase II: Smart-T + NRT
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.
Nicotine replacement therapy (NRT)
NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
Interventions
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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 about 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 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 about 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 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.
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.
Nicotine replacement therapy (NRT)
NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Willing and able to complete study procedures
* Willing to quit smoking for 14 days (Phase I) or willing to quit smoking for 13 weeks (Phase II)
Exclusion Criteria
* Report any allergies or negative reactions to odors/fragranced products
* Not being fluent in English
* Being pregnant by self-report
* 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
18 Years
ALL
Yes
Sponsors
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University of Pittsburgh
OTHER
University of Oklahoma
OTHER
Brown University
OTHER
University of Houston
OTHER
Responsible Party
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Lorra Garey
Research Assistant Professor
Principal Investigators
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Lorra Garey, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Houston
Michael Businelle, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma Health Sciences
Michael Sayette, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00004387
Identifier Type: -
Identifier Source: org_study_id
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