Smart Olfaction App to Reduce Relapse

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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
• Устройство 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.
• Устройство 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.
• Препарат Nicotine replacement therapy (NRT)
  NRT patches will be provided to assist with cravings and withdrawal symptoms following the quit attempts.
• Устройство 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.

Первичные конечные точки

• OSDS Use [Срок оценки: Phase I: Post randomization to End of Study (14 days post-quit date)]
• Odor Assessment [Срок оценки: Phase I: Post randomization to End of Study (14 days post-quit date)]
• Craving Reduction [Срок оценки: 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 [Срок оценки: Phase I: End of Study (14 days post-quit date). Phase II: End of Study (12 weeks post-quit date)]
• Smoking Abstinence [Срок оценки: Phase II: Randomization to End of Study]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

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

Идентификаторы

NCT: NCT07007195 · STUDY00004387

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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