Smart Olfaction App to Reduce Relapse

Official title

An Innovative Digitally-Delivered Olfactory Method for Reducing Cigarette Cravings and Supporting Smoking Cessation

Overview

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.

Interventions

• Device 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 o
• Device 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 swi
• Device 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.
• 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.
• Drug Nicotine replacement therapy (NRT)
  NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
• Device 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 measures

• 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]

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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, — Houston

Identifiers

NCT: NCT07007195 · STUDY00004387

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗