Smart Olfaction App to Reduce Relapse

Part of paid clinical trials in Houston, Texas.

Sponsor
University of Houston
Study ID
NCT07007195
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Nicotine Dependence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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™.
  • 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™.
  • 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.
  • 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.
  • Nicotine replacement therapy (NRT) — DRUG
    NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 22, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Ad Libitum followed by Instructed Use of the Inspire Device
  • Experimental: Phase I: Instructed Use followed by Ad Libitum Use of the Inspire Device
  • Experimental: Phase II: Smart-T app + NRT + Inspire
  • Active Comparator: Phase II: Smart-T + NRT

Primary Outcome Measure

OSDS Use [ Time Frame: Phase I: Post randomization to End of Study (14 days post-quit date) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and EmpowermentHoustonTexas77204
Lorra Garey, Ph.D.
[email protected]
713-743-8056

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By research site
RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment· Houston, TX

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