Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults

Обзор

The goal of this clinical trial is to determine 1) feasibility of the MOMENT-V intervention for cannabis use disorder in young adults, 2) feasibility of conducting the trial remotely, and 3) whether the MOMENT-V intervention reduces cannabis use frequency and problems. Researchers will compare the MOMENT-V intervention to usual care enhanced by a counselor meeting. Participants will either meet with a counselor two times and use an app on their phone for two weeks, or meet with a counselor briefly one time. All participants will be asked to complete electronic surveys, interviews with a research assistant, and saliva drug testing at home over three months.

Вмешательства

• Поведенческое Motivational Enhancement Therapy plus Ecological Momentary Intervention
  Two Motivational Enhancement Therapy (MET) sessions (1st, \~45 minutes; 2nd, \~30 minutes) between counselor and participant occur one week apart. MET sessions are personalized, interactive, face-to-face, and delivered according to a manual. MET session discussion topics include triggers for cannabis use, life goals/values, and development of a change plan. Participants then complete a 2-week Ecological Momentary Intervention (EMI) period. Survey prompts are sent 4x/day (3x/day at quasi-randomiz
• Поведенческое Enhanced Usual Care
  Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.

Первичные конечные точки

• Intervention completion [Срок оценки: At week 3 (Upon completion of 2-week EMI period)]
• EMI engagement [Срок оценки: In weeks 1-3 (during 2-week EMI period)]
• Acceptability: Overall satisfaction [Срок оценки: At 6-month timepoint]
• Acceptability: Components [Срок оценки: At week 0, week 1, and week 3]
• Screening [Срок оценки: During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)]
• Eligibility [Срок оценки: During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)]
• Enrollment [Срок оценки: Upon enrollment]
• Retention in trial [Срок оценки: At 3-week timepoint, 3-month timepoint, 6-month timepoint]
• Days of cannabis use [Срок оценки: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint]
• Times of cannabis use [Срок оценки: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint]

Вторичные конечные точки (9)

• Therapeutic alliance [Срок оценки: At week 1]
• MET counselor adherence to MI principles [Срок оценки: At week 0 and week 1]
• Duration of study activities [Срок оценки: All timepoints, upon completion of each timepoint (Baseline, week 0, week 1, weeks 1-3 [two-week EMI period], 3-weeks, 3-months, 6-months)]
• Cannabis use disorder (CUD) symptoms [Срок оценки: At Baseline, 3-month timepoint, 6-month timepoint]
• Amount of THC used [Срок оценки: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint]
• Motivation to change cannabis use [Срок оценки: At Baseline, week 0, week 1, 3-months, 6-months]
• Psychological distress [Срок оценки: At Baseline, 3-month timepoint, 6-month timepoint]
• Cognitive function [Срок оценки: At Baseline, 3-month timepoint, 6-month timepoint]
• Quality of life [Срок оценки: At Baseline, 3-month timepoint, 6-month timepoint]

Критерии участия

For the oral fluid testing pilot

Критерии включения

• Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice
• Participation in MOMENT-V open pilot
• Ownership of a smartphone
• Availability for the 2-week study duration

Критерии исключения

• Inability/Unwillingness to provide contact information
• Current pregnancy or parenting

For the pilot RCT

Критерии включения

• Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice or Martha Eliot Health Center Adolescent Clinic
• 18 to 26 years old
• Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score of ≥8
• Recreational cannabis use on \>3 days/week, on average, in the past 30 days
• Ownership of a smartphone that is PIN- or password-protected
• Ability to read and speak English
• Availability for the 6-month study duration

Критерии исключения

• Inability/Unwillingness to provide contact information
• Written certification from a physician for marijuana for medical use
• Current participation in a substance use treatment program or research study
• Current pregnancy or parenting
• Participation in prior MOMENT or MOMENT-V research

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Boston Children's Hospital — Boston

Публикации

• Shrier LA, Rhoads A, Burke P, Walls C, Blood EA. Real-time, contextual intervention using mobile technology to reduce marijuana use among youth: a pilot study. Addict Behav. 2014 Jan;39(1):173-80. doi: 10.1016/j.addbeh.2013.09.028. Epub 2013 Oct 4. PMID 24139665
• Shrier LA, Burke PJ, Kells M, Scherer EA, Sarda V, Jonestrask C, Xuan Z, Harris SK. Pilot randomized trial of MOMENT, a motivational counseling-plus-ecological momentary intervention to reduce marijuana use in youth. Mhealth. 2018 Jul 30;4:29. doi: 10.21037/mhealth.2018.07.04. eCollection 2018. PMID 30148142
• Shrier LA, McCaskill NH, Smith MC, O'Connell MM, Gluskin BS, Parker S, Everett V, Burke PJ, Harris SK. Telehealth counseling plus mHealth intervention for cannabis use in emerging adults: Development and a remote open pilot trial. J Subst Use Addict Treat. 2024 Nov;166:209472. doi: 10.1016/j.josat.2024.209472. Epub 2024 Aug 5. PMID 39111371

Идентификаторы

NCT: NCT06661031 · IRB-P00049240 · 1R34DA060500-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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