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Cannabis Use DisorderCAN-DONCT06661031

Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults

A study testing Motivational Enhancement Therapy plus Ecological Momentary Intervention in people with Cannabis Use Disorder, run by Boston Children's Hospital at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 26 years
Conditions the study is for
Cannabis Use Disorder
What is being tested?
Motivational Enhancement Therapy plus Ecological Momentary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
10 Dec 2024to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 26 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Inability/Unwillingness to provide contact information
  • Current pregnancy or parenting
  • For the pilot RCT
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Being tested
Motivational Enhancement Therapy plus Ecological Momentary Intervention, Enhanced Usual Care
Keywords
cannabis use, behavioral intervention, young adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational Enhancement Therapy plus Ecological Momentary InterventionBehavioural

    Also called MOMENT-V

    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.

  • Enhanced Usual CareBehavioural

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

Study groups in NCT06661031
Study groupRoleWhat they receive
Enhanced Usual Care armOtherParticipants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.
Receives: Behavioral: Enhanced Usual Care
Intervention armExperimentalParticipants 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]).
Receives: Behavioral: Motivational Enhancement Therapy plus Ecological Momentary Intervention
Oral fluid test pilotNo interventionPrior to RCT, single-arm pilot to test feasibility and acceptability of remote oral fluid testing.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

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

  2. 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

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

  3. 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)

    Measured: At 6-month timepoint

  4. 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

    Measured: At week 0, week 1, and week 3

  5. Screening

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

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

  6. Eligibility

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

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

  7. Enrollment

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

    Measured: Upon enrollment

  8. 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

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

  9. Days of cannabis use

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

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

  10. Times of cannabis use

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

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

  11. Negative consequences of cannabis use

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

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

Secondary outcomes (9)

  1. Therapeutic alliance

    [Aim 1] Working Alliance Inventory - Short Form, 12-items, 5-point Likert-type scale, total scale score and subscale scores (affective bond, perceived agreement on tasks, perceived agreement on goals; 4 items each), participant ("client") and observer versions reported separately and tested for agreement.

    Benchmark: ≥80% of participants with total score ≥48 (mean item score ≥4), participant version

    Measured: At week 1

  2. MET counselor adherence to MI principles

    [Aim 1] Measure of counselor adherence to MI principles in each MET session, as reported by participant. Sessions assessed with 7- to 9-item 5-point Likert-type scales (Strongly Disagree to Strongly Agree) developed for the study.

    Benchmark for each scale: ≥80% of participants with mean item score ≥4 out of 5

    Measured: At week 0 and week 1

  3. Duration of study activities

    [Aim 2] Duration of each study activity (in minutes)

    Measured: 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)

  4. Cannabis use disorder (CUD) symptoms

    [Aim 3] Symptom count measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM)

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

  5. Amount of THC used

    [Aim 3] Number of standard THC units (1 unit = 5 mg THC) derived from number of familiar units (joints, vapes, gummies, etc.) x amount per unit (grams, milligrams, or milliliters) x estimated potency (% THC), measured on TLFB calendar.

    If unable to calculate standard THC units: Number of familiar units (joints, vapes, gummies, etc.)

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

  6. Motivation to change cannabis use

    [Aim 3] One item each assessing readiness to, importance of, and confidence to change cannabis use, developed and used in our prior research, 11-point Likert-type scale for each. On follow-up, modified items about maintaining behavior if participant reports having started to change behavior but not having achieved change goals, or having changed behavior and achieved goals.

    Measured: At Baseline, week 0, week 1, 3-months, 6-months

  7. Psychological distress

    [Aim 3] Kessler Psychological Scale-6 (K6), assessing frequency of experiencing 6 symptoms in the past month on a 5-point Likert-type scale, with coding such that high scores indicate greater psychological distress.

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

  8. Cognitive function

    [Aim 3] PROMIS Cognitive Function v.2.0 - Short Form 6a, 6 items, 5-point Likert-type response, measures participant-perceived cognitive deficits in the past 7 days. Age- and gender-weighted T scores, higher T-scores indicating better cognitive function.

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

  9. Quality of life

    [Aim 3] PROMIS Global Health v1.2, a 10-item, 5-point Likert-type response (except pain item 0-10), participant-reported measure of physical, mental, and social health, in general except for past 7 days for emotional problems, fatigue, and pain. Age- and gender-weighted T scores, higher T-scores indicating better quality of life.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start10 Dec 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06661031
Sponsor's protocol ID
IRB-P00049240
Other IDs
1R34DA060500-01A1
Acronym
CAN-DO
Status last verified
Dec 2025
First submitted
22 Oct 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified survey and oral fluid testing data

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 39111371

  • Shrier LA, Palmer A, Parker S, Kossowsky J, Katz-Wise SL, Burke PJ, Milliren CE, Harris SK. Telehealth-Plus-mHealth Intervention for Young Adults With Cannabis Use Disorder: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 20;15:e105908. doi: 10.2196/105908.

    PubMed 42622852

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Enhancement Therapy plus Ecological Momentary Intervention in people with Cannabis Use Disorder, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention completion (time frame: At week 3 (Upon completion of 2-week EMI period)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06661031, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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