Recruiting
Early Phase 1

Smart-T & OSDS

Sponsor:

University of Houston

Code:

NCT07007195

Conditions

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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)

Study Details

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

Study ID

NCT07007195

Start date

Apr 22, 2026

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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 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

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

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.

Primary outcome measure

  • OSDS Use [ Time Frame: Phase I: Post randomization to End of Study (14 days post-quit date) ]
  • Odor Assessment [ Time Frame: Phase I: Post randomization to End of Study (14 days post-quit date) ]
  • 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) ]
  • Device Acceptability [ Time Frame: Phase I: End of Study (14 days post-quit date). Phase II: End of Study (12 weeks post-quit date) ]
  • Smoking Abstinence [ Time Frame: Phase II: Randomization to End of Study ]

Central Contacts and Locations

Central contacts

Lorra Garey, Ph.D.

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

Michael Businelle, Ph.D.

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

Locations

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

Recruiting

Houston, Texas, United States, 77204

Contacts

Lorra Garey, Ph.D.

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

More Information

Sponsor

University of Houston

Last update posted

Jul 8, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by University of Houston on 2026-07-08.