Smart Olfaction App to Reduce Relapse (SOARR)

University of Houston

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Nicotine Dependence

Treatments: Drug: Nicotine replacement therapy (NRT); Device: Inspire Device; Device: Smart-T Smoking Cessation App Without the Inspire Device Condition; Device: Smart-T Smoking Cessation App with the Inspire Device Condition; Device: Ad Libitum Use followed by Instructed Use of the Inspire Device; Device: Instructed Use followed by Ad Libitum Use of the Inspire Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07007195

STUDY00004387

Details and patient eligibility

About

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.

Full description

The objective of the current trial is to refine a novel biobehavioral smoking cessation intervention that integrates the strategic application of olfactory stimulation to reduce cigarette cravings (olfactory stimulation delivery system; OSDS) and then to test the OSDS as an adjunctive support for smoking cessation when integrated with an established smartphone-based smoking cessation application (Smart-T).

The study will be conducted in two phases. Phase I will consist of a crossover, micro-randomized controlled trial to inform methodology for odor administration and examine the effects of OSDS on craving reduction. Treatment-seeking smokers (N=32) will engage in a self-guided quit attempt and use the OSDS for 14 days. Using a crossover randomization design, participants will complete 7 days of ad libitum OSDS use and 7 days of instructed OSDS use. Participants will complete an initial online pre-screener, an enrollment call, a baseline survey via the app, a randomization call, and 5 daily EMAs during the study. At the end of Phase I, participants will complete a qualitative interview over Zoom and a quantitative survey in the app to assess their experiences. Phase II will be a RCT in which participants (N=100) will be randomized to either (1) Smart-T with a nicotine patch (Smart-T) or (2) Smart-T with a nicotine patch and OSDS as an adjunctive feature (Smart-T+O). Participants will complete a baseline assessment, daily EMAs for 13 weeks (1-week pre-quit and 12 weeks post-quit), a follow-up assessment at 12 weeks post-quit via the app, and a qualitative interview over Zoom. All participants will have access to Smart-T intervention materials for smoking cessation. Smoking status will be biochemically verified at multiple time points using a Carbon Monoxide monitor, which will be mailed to participants along with usage instructions.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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
• 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
• Willing and able to complete study procedures
• Willing to quit smoking for 14 days (Phase I) or willing to 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
• Not being fluent in English
• Being pregnant by self-report
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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132 participants in 4 patient groups

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

Experimental group

Treatment:

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

Device: Inspire Device

Drug: Nicotine replacement therapy (NRT)

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

Experimental group

Treatment:

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

Device: Inspire Device

Drug: Nicotine replacement therapy (NRT)

Phase II: Smart-T app + NRT + Inspire

Experimental group

Treatment:

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

Device: Inspire Device

Drug: Nicotine replacement therapy (NRT)

Phase II: Smart-T + NRT

Active Comparator group

Treatment:

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

Drug: Nicotine replacement therapy (NRT)