Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults

NCT06661031 | Enrolling By Invitation

• 2 other identifiers: IRB-P000492401R34DA060500-01A1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Keywords

cannabis use; behavioral intervention; young adult

Outcome Measures

Primary Outcomes (11)

• Intervention completion

  \[Aim 1\] Percent of participants assigned to the intervention arm completing the intervention (defined as both MET sessions and any EMI surveys). Benchmark: ≥80%

  At week 3 (Upon completion of 2-week EMI period)

• EMI engagement

  \[Aim 1\] Percent of days on which participant responded to at least one survey during the 14 days of EMI. Benchmark: Median of ≥80% across intervention participants

  In weeks 1-3 (during 2-week EMI period)

• Acceptability: Overall satisfaction

  \[Aim 1\] Satisfaction with intervention measured on the Client Satisfaction Questionnaire-8, an 8-item 4-point scale on which scores range from 8-32, with higher scores indicating greater satisfaction. Benchmark: ≥80% of participants with a scale score ≥24 (mean item score of ≥3 out 4)

  At 6-month timepoint

• Acceptability: Components

  \[Aim 1\] Measure of acceptability (usability, likability, perceived effect, burden) for each intervention component (2 MET sessions and EMI). Components assessed with an 11- or 12-item 5-point Likert-type scales (1, Strongly Disagree to 5, Strongly Agree) developed for the study. Higher scores indicate greater acceptability. Benchmark for each scale: ≥80% of participants with mean item score ≥4 out of 5

  At week 0, week 1, and week 3

• Screening

  \[Aim 2\] Number of patients self-screening per month. Benchmark: ≥13 per month

  During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)

• Eligibility

  \[Aim 2\] Number of patients eligible per month. Benchmark: ≥6 per month

  During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)

• Enrollment

  \[Aim 2\] Number of patients enrolled per month. Benchmark: ≥3 per month

  Upon enrollment

• Retention in trial

  \[Aim 2\] Percent of participants retained at each assessment time point (3 weeks, 3 months, 6 months, by assigned condition. Benchmark: ≥80% at each time point

  At 3-week timepoint, 3-month timepoint, 6-month timepoint

• Days of cannabis use

  \[Aim 3\] Number of cannabis use days measured on Timeline Follow-Back (TLFB) calendar

  At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint

• Times of cannabis use

  \[Aim 3\] Number of cannabis use times measured on TLFB calendar

  At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint

• Negative consequences of cannabis use

  \[Aim 3\] Number of negative consequences (problems) measured on the 19-item Marijuana Problems Scale

  At Baseline, 3-month timepoint, 6-month timepoint

Secondary Outcomes (9)

• Therapeutic alliance

  At week 1

• MET counselor adherence to MI principles

  At week 0 and week 1

• Duration of study activities

  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

  At Baseline, 3-month timepoint, 6-month timepoint

• Amount of THC used

  At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint

Other Outcomes (4)

• Oral fluid acceptability

  At 2-week timepoint in oral fluid pilot phase; At 3-month timepoint and 6-month timepoint in pilot RCT phase

• Oral fluid collection

  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

• Oral fluid - self-reported cannabis use agreement

  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

Study Arms (3)

Enhanced Usual Care arm

OTHER

Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.

Behavioral: Enhanced Usual Care

Intervention arm

EXPERIMENTAL

Participants meet with a counselor 1-on-1 via videoconference and receive MOMENT-V (mHealth intervention involving 2 Motivational Enhancement Therapy \[MET\] sessions with a trained counselor and 2 weeks of smartphone-based Ecological Momentary Assessment \[EMI\]).

Behavioral: Motivational Enhancement Therapy plus Ecological Momentary Intervention

Oral fluid test pilot

NO INTERVENTION

Prior to RCT, single-arm pilot to test feasibility and acceptability of remote oral fluid testing.

Interventions

Motivational Enhancement Therapy plus Ecological Momentary Intervention BEHAVIORAL

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-randomized times, 1x/day at fixed time; \~2 mins each) that ask about the participant's recent cannabis use. Depending on answers reported, the participant can receive tailored messages that support their self-efficacy and prompt use of coping strategies.

Also known as: MOMENT-V

Intervention arm

Enhanced Usual Care BEHAVIORAL

Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.

Enhanced Usual Care arm

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Inability/Unwillingness to provide contact information
• Current pregnancy or parenting
• For the pilot RCT
• Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice or Martha Eliot Health Center Adolescent Clinic
• to 26 years old
• Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score of ≥12
• 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
• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, Division of Adolescent/Young Adult Medicine

Model Details: 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).

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 28, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified scientific data will be shared as soon as possible. De-identified scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository for at least 5 years.
• Access Criteria: De-identified scientific data and metadata arising from the project will be archived in the openICPSR repository. De-identified scientific data from this project will be findable through summary information (metadata) that will be readily available on the Center for Adolescent Behavioral Health Research website, the repository website, and clinicaltrials.gov.

Locations

US (1)