RecruitingEarly Phase 1NCT07007195

Smart Olfaction App to Reduce Relapse

An Innovative Digitally-Delivered Olfactory Method for Reducing Cigarette Cravings and Supporting Smoking Cessation


Sponsor

University of Houston

Enrollment

132 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria15

  • 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 Criteria9

  • 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)

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Interventions

DEVICEAd 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™.

DEVICEInstructed 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™.

DEVICESmart-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.

DEVICESmart-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.

DRUGNicotine replacement therapy (NRT)

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

DEVICEInspire 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.


Locations(1)

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

Houston, Texas, United States

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NCT07007195


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