Smart Olfaction App to Reduce Relapse

NCT07007195 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00004387
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nicotine Dependence

Keywords

Substance-Related Disorders; Smoking Cessation; Smartphone-Based Smoking Cessation; Nicotine Dependence

Outcome Measures

Primary Outcomes (5)

• OSDS Use

  Descriptive data regarding use times and frequency will be assessed.

  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.

  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.

  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.

  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.

  Phase II: Randomization to End of Study

Study Arms (4)

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)

Interventions

Ad Libitum Use followed by Instructed Use of the Inspire Device 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™.

Phase I: Ad Libitum followed by Instructed Use of the Inspire Device

Nicotine replacement therapy (NRT) DRUG

NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.

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

Instructed Use followed by Ad Libitum Use of the Inspire Device 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™.

Phase I: Instructed Use followed by Ad Libitum Use of the Inspire Device

Smart-T Smoking Cessation App with the Inspire Device Condition DEVICE

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.

Phase II: Smart-T app + NRT + Inspire

Smart-T Smoking Cessation App Without the Inspire Device Condition DEVICE

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.

Phase II: Smart-T + NRT

Inspire Device 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: 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: collaborator
• University of Houston: lead
• University of Oklahoma: collaborator
• Brown University: collaborator

Study Sites (1)

RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Substance-Related Disorders; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Lorra Garey, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

• Michael Businelle, Ph.D.

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

• Michael Sayette, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorra Garey, Ph.D.

CONTACT

713-743-8056; llgarey@central.uh.edu

Michael Businelle, Ph.D.

CONTACT

405-271-8001; Michael-Businelle@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Cross-over assignment (Phase I) and Parallel assignment (Phase II)

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 5, 2025
• Study Start: April 22, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)