Clinical trial NCT06661031: Developing a Telehealth + MHealth Cannabis Use Intervention for Young Adults
Official title: Developing a Telehealth + MHealth Cannabis Use Intervention for Young Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cannabis Use Disorder
Keywords: cannabis use
behavioral intervention
young adult
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-10-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The oral fluid testing pilot is a single-arm preliminary examination of remote oral fluid test feasibility and acceptability (anticipated n = up to 5).

The pilot randomized controlled trial is a parallel, 2-arm, trial with 1:1 randomized allocation to the MOMENT-V intervention versus Enhanced Care, stratified by sex (male vs. not male), race (Black or African American vs. not Black or African American), cannabis use frequency (daily vs. not daily), and site (Boston Children's Hospital Adolescent/Young Adult Medical Practice vs. Martha Eliot Health Center Adolescent Clinic) (anticipated n=60).
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: For the oral fluid testing pilot

Inclusion Criteria:

* 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

Exclusion Criteria:

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

For the pilot RCT

Inclusion Criteria:

* 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 ≥12
* Recreational cannabis use on \&gt;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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intervention completion
timeFrame: At week 3 (Upon completion of 2-week EMI period)
measure: EMI engagement
timeFrame: In weeks 1-3 (during 2-week EMI period)
measure: Acceptability: Overall satisfaction
timeFrame: At 6-month timepoint
measure: Acceptability: Components
timeFrame: At week 0, week 1, and week 3
measure: Screening
timeFrame: During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)
measure: Eligibility
timeFrame: During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)
measure: Enrollment
timeFrame: Upon enrollment
measure: Retention in trial
timeFrame: At 3-week timepoint, 3-month timepoint, 6-month timepoint
measure: Days of cannabis use
timeFrame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
measure: Times of cannabis use
timeFrame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
measure: Negative consequences of cannabis use
timeFrame: At Baseline, 3-month timepoint, 6-month timepoint
Secondary outcomes:
measure: Therapeutic alliance
timeFrame: At week 1
measure: MET counselor adherence to MI principles
timeFrame: At week 0 and week 1
measure: Duration of study activities
timeFrame: 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)
measure: Cannabis use disorder (CUD) symptoms
timeFrame: At Baseline, 3-month timepoint, 6-month timepoint
measure: Amount of THC used
timeFrame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
measure: Motivation to change cannabis use
timeFrame: At Baseline, week 0, week 1, 3-months, 6-months
measure: Psychological distress
timeFrame: At Baseline, 3-month timepoint, 6-month timepoint
measure: Cognitive function
timeFrame: At Baseline, 3-month timepoint, 6-month timepoint
measure: Quality of life
timeFrame: At Baseline, 3-month timepoint, 6-month timepoint
Other outcomes:
measure: Oral fluid acceptability
timeFrame: At 2-week timepoint in oral fluid pilot phase; At 3-month timepoint and 6-month timepoint in pilot RCT phase
measure: Oral fluid collection
timeFrame: For 3 days before and on the day of 2-week timepoint in oral fluid pilot phase; For 3 days before and on the day of 3-month timepoint and at 6-month timepoint in pilot RCT phase
measure: Oral fluid - self-reported cannabis use agreement
timeFrame: For 3 days before and on the day of 2-week timepoint in oral fluid pilot phase; For 3 days before and on the day of 3-month timepoint and at 6-month timepoint in pilot RCT phase
measure: Cannabis nonuse interval
timeFrame: For 4 days before and on the day of 2-week timepoint in oral fluid pilot phase; For 4 days before and on the day of 3-month timepoint and at 6-month timepoint in pilot RCT phase
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.