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Enrolling by Invitation

NCT Number: NCT06661031

Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults

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.

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Key information

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 >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

Treatment and study plan

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.

Other names: MOMENT-V

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.

Primary outcomes

  1. Intervention completion

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

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

  2. EMI engagement

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

    [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

  3. Acceptability: Overall satisfaction

    Time frame: At 6-month timepoint

    [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)

  4. Acceptability: Components

    Time frame: At week 0, week 1, and week 3

    [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

  5. Screening

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

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

  6. Eligibility

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

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

  7. Enrollment

    Time frame: Upon enrollment

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

  8. Retention in trial

    Time frame: At 3-week timepoint, 3-month timepoint, 6-month timepoint

    [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

  9. Days of cannabis use

    Time frame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint

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

  10. Times of cannabis use

    Time frame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint

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

  11. Negative consequences of cannabis use

    Time frame: At Baseline, 3-month timepoint, 6-month timepoint

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

Secondary outcomes

  1. Therapeutic alliance

    Time frame: At week 1

    [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

  2. MET counselor adherence to MI principles

    Time frame: At week 0 and week 1

    [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

  3. Duration of study activities

    Time frame: 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)

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

  4. Cannabis use disorder (CUD) symptoms

    Time frame: At Baseline, 3-month timepoint, 6-month timepoint

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

  5. Amount of THC used

    Time frame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint

    [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.)

  6. Motivation to change cannabis use

    Time frame: At Baseline, week 0, week 1, 3-months, 6-months

    [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.

  7. Psychological distress

    Time frame: At Baseline, 3-month timepoint, 6-month timepoint

    [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.

  8. Cognitive function

    Time frame: At Baseline, 3-month timepoint, 6-month timepoint

    [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.

  9. Quality of life

    Time frame: At Baseline, 3-month timepoint, 6-month timepoint

    [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.

Other outcomes

  1. Oral fluid acceptability

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

    [Exploratory Aim] Measure of acceptability (usability, likability, burden), 5 items, 5-point Likert-type scale (1, Strongly Disagree to 5, Strongly Agree), with higher scores indicating greater acceptability

  2. Oral fluid collection

    Time frame: 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

    [Exploratory Aim] Number and percent of videos of self-testing completed out of those expected, per participant Number and percent of observations of self-testing during study visit out of those expected, per participant

  3. Oral fluid - self-reported cannabis use agreement

    Time frame: 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

    [Exploratory Aim] Agreement between oral fluid test results (positive/negative) and cannabis use reported on TLFB calendar for the day of testing or the day before testing (use/no use on either day)

  4. Cannabis nonuse interval

    Time frame: 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

    [Exploratory Aim] Oral fluid test results for delta-9-tetrahydrocannabinol on 4 consecutive days (all negative = nonuse over 5 days/any positive = use within the 5 days)

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: CAN-DO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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