Clinical trial NCT07007195: Smart Olfaction App to Reduce Relapse
Official title: An Innovative Digitally-Delivered Olfactory Method for Reducing Cigarette Cravings and Supporting Smoking Cessation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Nicotine Dependence
Keywords: Substance-Related Disorders
Smoking Cessation
Smartphone-Based Smoking Cessation
Nicotine Dependence
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: University of Oklahoma
name: Brown University
First posted: 2025-06-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over assignment (Phase I) and Parallel assignment (Phase II)
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: OSDS Use
timeFrame: Phase I: Post randomization to End of Study (14 days post-quit date)
measure: Odor Assessment
timeFrame: Phase I: Post randomization to End of Study (14 days post-quit date)
measure: Craving Reduction
timeFrame: 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)
measure: Device Acceptability
timeFrame: Phase I: End of Study (14 days post-quit date). Phase II: End of Study (12 weeks post-quit date)
measure: Smoking Abstinence
timeFrame: Phase II: Randomization to End of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment
state: Texas
Study officials:
References: