Boston Children's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT06661031
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.
Interested in participating?
Request Info18 year–26 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For the oral fluid testing pilot
Inclusion criteria
Exclusion criteria
For the pilot RCT
Inclusion criteria
Exclusion criteria
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
Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.
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%
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
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)
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
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
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
Time frame: Upon enrollment
[Aim 2] Number of patients enrolled per month. Benchmark: ≥3 per month
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
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
Time frame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
[Aim 3] Number of cannabis use times measured on TLFB calendar
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
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
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
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)
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)
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.)
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.
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.
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.
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.
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
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
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)
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)
Boston Children's Hospital
Other
Acronym: CAN-DO
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