Health TrialsbyHealthPanel

Smart Olfaction App to Reduce Relapse

ConditionNicotine Dependence
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Houston

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

132 Participants
are divided into 4 treatment groups
Group A: Phase I: Ad Libitum followed by Instructed Use of the Inspire DeviceExperimental treatment 3 interventions
Group B: Phase I: Instructed Use followed by Ad Libitum Use of the Inspire DeviceExperimental treatment 3 interventions
Group C: Phase II: Smart-T app + NRT + InspireExperimental treatment 3 interventions
Group D: Phase II: Smart-T + NRTActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

OSDS Use

Descriptive data regarding use times and frequency will be assessed.

Time frame
Phase I: Post randomization to End of Study (14 days post-quit date)
2

Odor Assessment

Reports of odor assessment will be used to determine if sniffing specific odors reduce craving more than an odor blank.

Time frame
Phase I: Post randomization to End of Study (14 days post-quit date)
3

Craving Reduction

Participants will report craving levels multiple times per day via the app. Reduction in craving levels over time will be analyzed.

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)
4

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.

Time frame
Phase I: End of Study (14 days post-quit date). Phase II: End of Study (12 weeks post-quit date)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Houston

Lead sponsor

University of Pittsburgh

Collaborator

University of Oklahoma

Collaborator

Brown University

Collaborator

Source ClinicalTrials.gov
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