Cannabis Use Disorder
Conditions
Keywords
cannabis use, behavioral intervention, young adult
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.
Interventions
BEHAVIORALMotivational Enhancement Therapy plus Ecological Momentary Intervention
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.
BEHAVIORALEnhanced Usual Care
Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.
Sponsors
Boston Children's Hospital
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
No
Inclusion 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 ≥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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention completion | 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% |
| EMI engagement | 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 |
| Acceptability: Overall satisfaction | 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) |
| Acceptability: Components | 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 |
| Screening | During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline) | \[Aim 2\] Number of patients self-screening per month. Benchmark: ≥13 per month |
| Eligibility | During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline) | \[Aim 2\] Number of patients eligible per month. Benchmark: ≥6 per month |
| Enrollment | Upon enrollment | \[Aim 2\] Number of patients enrolled per month. Benchmark: ≥3 per month |
| Retention in trial | 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 |
| Days of cannabis use | 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 |
| Times of cannabis use | At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint | \[Aim 3\] Number of cannabis use times measured on TLFB calendar |
| Negative consequences of cannabis use | At Baseline, 3-month timepoint, 6-month timepoint | \[Aim 3\] Number of negative consequences (problems) measured on the 19-item Marijuana Problems Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic alliance | 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 |
| MET counselor adherence to MI principles | 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 |
| 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) | \[Aim 2\] Duration of each study activity (in minutes) |
| Cannabis use disorder (CUD) symptoms | At Baseline, 3-month timepoint, 6-month timepoint | \[Aim 3\] Symptom count measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM) |
| Amount of THC used | 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.) |
| Motivation to change cannabis use | 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. |
| Psychological distress | 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. |
| Cognitive function | 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. |
| Quality of life | 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. |
Countries
United States
Outcome results
None listed