Frequent cannabis use has increased in the last 20 years to reach historic levels among young adults in the United States [1], with rates of daily use in this age group as high as 19%‐21% in states that have legalized recreational cannabis use [2]. Approximately 1 in 3 young people who use cannabis regularly (weekly or daily) meet criteria for cannabis use disorder (CUD) [3], an estimated 5.5 million young adults in 2024 [4]. Concurrent with the increase in frequent cannabis use, there has been a >3-fold increase in the potency of cannabis products [5], a substantial increase in vaping of high-potency cannabis oils among young adults [1], and a rise in emergency department visits involving cannabis, particularly for adolescents and young adults [6,7]. Heavy cannabis exposure during brain development (through the 20s) [8] is associated with increased risk of CUD, other substance use disorders, psychosis, and other psychiatric disorders, as well as decreased educational and occupational success [9-12]. Furthermore, cannabis use is associated with adverse cardiovascular and pulmonary effects, and CUD resulting in hospital-based care has been linked to premature death [13].

Increases in the legalization of recreational cannabis and declines in the perceived risk of harm from cannabis have heralded not only increases in cannabis use, but also decreases in the perceived need for and use of CUD treatment among young adults [14-16]. Consequently, despite the substantial need, fewer than 3% of young adults with past-year CUD receive outpatient treatment [14]. Specific barriers to young adults seeking treatment include not feeling worthy of support, fearing stigma, having financial concerns, and encountering logistical or structural issues, including limited availability and accessibility of developmentally appropriate services [17,18]. There is an urgent need to develop, evaluate, disseminate, and implement interventions for young adults with CUD that address barriers to and reduce disparities in receipt of effective treatment [16,19].

Motivational interventions – including motivational enhancement therapy (MET), which incorporates motivational interviewing (MI) with personal feedback [20] – are at the forefront of brief substance use treatment [21-24]. Individuals aged 18 to 26 years are in the developmental period between adolescence and adulthood, when they are focusing on themselves and exploring their identity, a time ripe for reflection [25]. During this time, young adults may both be engaging in health-risk behaviors, such as frequent cannabis use, and be open to change to better align their behaviors with their life goals. Consistent with this, baseline motivation to change predicts decreases in cannabis use and associated problems [26-30]. Thus, it is particularly important and salient to develop and test motivational interventions for young adults.

Brief interventions (1‐2 sessions) for young adults do reduce CUD symptoms and increase the likelihood of abstinence in the short term [21], but effects are small and not sustained [31-33]. Psychosocial interventions for adults with CUD that have more than 4 sessions and last more than 1 month have better outcomes [34]. Combining a motivational intervention with other approaches may enhance effectiveness [35], but it adds time, expense, and training needs. Novel approaches to brief motivational interventions for young adults with CUD are required to address the high unmet need, age-specific barriers and facilitators, and challenges to achieving long-term effectiveness.

Primary care is a promising setting in which to offer treatment for CUD in young adults. Most young adults have a primary care provider [36] and have had a wellness visit in the past year [37]. SBIRT (Screening, Brief Intervention, and Referral to Treatment) is already recommended as part of routine care to enable early intervention for those with problematic substance use [38,39]. Young adults disclose cannabis use during screening in primary care at rates similar to or higher than those in surveillance surveys [40]. In one large health care system, 31% of primary care patients aged 18 to 29 years reported using cannabis in the past 3 months, of whom 39% were at moderate to high risk of CUD [41]. Using trained interventionists to deliver treatment has facilitated sustained SBIRT in primary care [42,43]. However, for CUD interventions for large numbers of affected young adult patients to be implemented at scale, challenges with staffing, time, cost, and space in primary care must be overcome [44].

Digital health interventions, including telehealth, websites, and mobile health (mHealth) apps, offer means of addressing implementation challenges in primary care while leveraging the trust in familiar clinicians, staff, and systems—a cornerstone of young adult care-seeking and disclosure behaviors [45]—to support engagement with treatment. In a meta-analysis, at the 3-month follow-up, digital health interventions for young adults reduced cannabis use by almost 1 week in the previous month, compared with control conditions [46]. Telehealth has been widely adopted in primary care, with more than 70% of physicians working in practices that offer videoconferencing with patients [47].

Because telehealth allows open and nonjudgmental live communication, expressions of acceptance and compassion, and the building of rapport between counselor and client, telehealth may be better suited to motivational interventions than computerized or online interventions [48]. Adding mHealth interventions (eg, SMS text messaging, momentary assessment, and intervention) to face-to-face counseling can improve psychiatric treatment outcomes [49], suggesting that a telehealth-plus-mHealth intervention could be an efficient and effective approach to CUD treatment for young adults in primary care.

Based on our prior observational and intervention research [50-52], we developed a telehealth-plus-mHealth intervention for young adults with CUD to be delivered in primary care. The Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy—Virtual (MOMENT-V) intervention includes 2 MET sessions delivered by telehealth, followed by 2 weeks of ecological momentary intervention (EMI; a brief assessment and intervention in real time and in real life) (Figure 1) [53]. The MET involves 2 manualized 45- to 60-minute sessions, 1 week apart, with a counselor who is a clinician trained in behavior change counseling (eg, a psychologist or nurse practitioner). Sessions include engaging hands-on and cognitive activities. In the first session (~45‐60 min), the counselor establishes rapport; elicits personal goals and values; discusses the young adult’s cannabis history, behaviors, reasons, and expectancies; briefly discusses other substance use; develops a discrepancy between use and the young adult’s values and goals; and explores the possibility of change. During this session, the young adult identifies their triggers for cannabis use from lists of affective states and social contexts, then selects their top 3 triggers. In the second session (~30‐45 min), the counselor provides personalized feedback; evokes motivation for changing use; conducts a decisional balance exercise; assesses the importance of and readiness for change; explores and enhances self-efficacy for change; helps the young adult develop a change plan (“My Journey”); reviews withdrawal symptoms; and assesses confidence in their ability to change.

Following the second MET session, participants receive electronic notifications to respond to 3 momentary surveys and 1 daily survey each day for 14 days. The momentary surveys are prompted at quasi-random times in the morning, afternoon, and evening to assess momentary experience. The momentary surveys query social and emotional contexts associated with the desire to use cannabis and with subsequent use, reasons for use, use of cannabis and other substances, avoidance efforts, and coping strategies. When participants indicate exposure to a personal top-3 trigger context in a momentary survey, they immediately receive a message supporting self-efficacy, evoking the behavior change plan they developed in MET, and prompting them to consider their personal coping strategies, drawing on research indicating the effectiveness of cognitive behavioral therapy combined with MET [54-56]. Participants also receive messages after reporting desire for cannabis, use, and efforts to avoid use. One survey is prompted at a time of the participant’s choosing to permit a daily summary of and reflection on use behaviors, social and emotional contexts, craving, and withdrawal symptoms. Each survey takes 2 to 3 minutes, depending on reported use and the number of messages.

In our previously developed intervention, which comprised in-person MET and an EMI, nearly all participants who were exposed to the MET rated it as excellent or good and reported changes in their cannabis use motivation and behavior related to cannabis use after counseling [51]. We applied our framework to adapt in-person counseling for virtual delivery, updated the counseling language, and created new materials to enhance the sessions. Additionally, we created a website to host intervention materials and resources for participants. We also developed new EMI messaging content and format to improve integration with the MET, expanded the message bank, and implemented a programming algorithm to minimize repetition over the 2-week EMI.

Following human-centered design principles [57], we approached the challenges of CUD treatment in primary care generally and of MOMENT-V specifically by centering on the people experiencing the challenges: young people and their clinicians [51]. Accordingly, we worked with youth throughout the adaptation process, including development, testing, review, and revision. Youth were directly involved in decisions regarding activity design, interactivity, functionality, and order, as well as the balance between face time and screen-sharing during the video counseling sessions. We also worked with mental health and medical clinicians in primary care to develop robust safety procedures for the virtual intervention. We then conducted an open pilot study with primary care patients aged 18 to 25 years who reported recreational cannabis use at least 3 times per week (N=14) [51]. All participants completed the 2 MET sessions and at least 1 EMI survey and reported high satisfaction with the intervention. Confidence to change cannabis use was higher postintervention and at 2-month follow-up, compared to baseline. Additionally, cannabis use frequency decreased by the 2-month follow-up.

Building on this strong theoretical and empirical foundation, we now seek to determine intervention and trial feasibility in a pilot randomized controlled trial (RCT) of MOMENT-V vs enhanced usual care (EUC) in young adult primary care patients with CUD. For intervention feasibility, the primary outcomes will be completion, EMI engagement, and acceptability; the secondary outcomes will be counselor adherence to MI principles and therapeutic alliance. With an eye on expanding the reach, accessibility, and engagement in substance use research, as well as in interventions for young adults, we will evaluate remote trial feasibility, with primary outcomes of screening, eligibility, enrollment, and retention rates, and a secondary outcome of duration of study activities. In anticipation of a future efficacy trial, we will examine cannabis use frequency and problems from cannabis use, as well as CUD symptoms, amount of delta-9-tetrahydrocannabinol (THC) used, motivation to change use, psychological distress, cognitive function, and quality of life.

The study design is a 2-arm, parallel group, pilot RCT with 1:1 allocation of young adult primary care patients with CUD to MOMENT-V or EUC. Following self-screening indicating eligibility, patients will be scheduled for a remote baseline visit, at which they will be enrolled, randomly assigned to their study condition, and will receive their assigned condition. During remote study visits at baseline, 3 weeks, 3 months, and 6 months, the research assistant will send the participant electronic surveys to complete during the visit and will conduct timeline followback (TLFB) interviews [58]. In addition, at the end of the 6-month visit, the research assistant will conduct a semistructured feedback interview. The study includes an exploration of the use of oral fluid testing to evaluate change in cannabis use in clinical trials. The oral fluid testing protocol will be described in a future publication.

Participants will be aged 18 to 26 years, be primary care patients at a recruitment clinic, and have a CUD Identification Test-Revised (CUDIT-R) score ≥12 or more. The CUDIT-R is a self-report measure assessing problematic cannabis use during the past 6 months, with 7 items, each rated on a 5-point Likert-type scale from 0 to 4, and 1 item rated 0, 2, or 4; item scores are summed, and scores of ≥12 are 91% sensitive and 90% specific for CUD [59]. Participants will also meet these additional inclusion criteria: recreational cannabis use on 3 or more days per week, on average, in the past 30 days; ownership of a smartphone; ability to read and speak English; and availability for the 6-month study duration. Participants will not meet any of the following exclusion criteria: a medical or psychiatric condition that, in the opinion of the study principal investigator, would prevent safe participation in the study; inability or unwillingness to provide contact information; written certification from a physician for marijuana for medical use; currently receiving specialized counseling or treatment services for a substance use problem; or participation in prior MOMENT or MOMENT-V research. As in our prior research in young adults with CUD, we will also exclude individuals who are pregnant or parenting owing to safety and social concerns or potential disclosures that cannot be adequately addressed in our brief, remotely delivered intervention and EUC conditions. Pregnancy and parenting status will be self-reported on the electronic eligibility survey.

Participants in both conditions will continue to receive standard clinical care, which could include regular follow-up visits or referrals to behavioral health or substance use treatment, as determined by a clinician caring for them. Receipt of care outside the study will be assessed on each follow-up survey. Participants will be remunerated up to US $260 in e-gift cards, prorated based on completion of study activities. Payment will be based solely on completion of study activities and will not be contingent on cannabis use, abstinence, or any other outcome. Participation in the study is voluntary, and participants may choose to leave the study at any time.

Patients at the recruitment clinics aged 18 to 26 years who have a history of problematic cannabis use but do not currently have a CUDIT-R score of 12 or more (and are therefore ineligible to enroll in the study) may be invited to participate in the study’s Advisory Board. The Advisory Board will meet 1‐2 times a year for approximately 2 years during participant-related procedures (ie, recruitment, enrollment, intervention delivery, and assessment) and data analysis. The Advisory Board will be asked to provide feedback on study materials, procedures, findings, and dissemination plans.

Patients will be recruited from clinics in eastern Massachusetts that provide primary care to young adults. The initial recruitment sites will be 2 clinics affiliated with a pediatric teaching hospital. Additional sites (eg, Boston-area community health centers) will be added as needed to meet enrollment goals. In Massachusetts, recreational cannabis use is legal for individuals aged 21 years and older [60].

Patients will be invited to self-screen for the study through flyers with a QR code displayed in clinics, clinician invitations, and research assistant invitations (eg, patient portal messages). The QR code will link to a self-administered screening survey assessing eligibility and collecting contact information. The survey will also collect the name of the patient’s primary care clinician to contact if the patient reports a safety concern. The survey will include information about how to reach a clinician at the clinic if questions or concerns arise while completing the survey.

The initial study visit will occur via a video call. Following enrollment, the participant will self-administer the baseline survey on demographic characteristics and cannabis use-related history, symptoms, and problems. After the participant has completed the survey, the research assistant will conduct a substance use TLFB calendar interview for the past 30 days. The research assistant will then initiate the electronic randomization module and view the participant’s assigned condition. The research assistant will then invite the study counselor to join the video call.

We will assess the study outcomes using self-report surveys, TLFB calendar interviews, semistructured feedback interviews, and study tracking logs at baseline, postintervention, and 3-week, 3-month, and 6-month follow-ups.

This study confers no more than minimal risk. The study topic could make participants feel uncomfortable or upset, in which case they may skip questions or decide not to continue. Participants could be prompted to answer EMI surveys in situations that may be inconvenient or dangerous, such as during class or while driving; they will be encouraged to use their best judgment about when to complete them. There is a risk of breaches of privacy and confidentiality; participants will be advised to complete study activities in private places where they will not be seen or overheard, and they will be informed that their data will be stored securely. As part of the informed consent process, participants are also advised that the study team will notify their primary care clinician of their enrollment in the study and that, if they meet a clinically informed safety threshold, the clinician will be notified without revealing the participant’s specific responses. Safety thresholds include any of the following self-reported behaviors over the past 30 days: recent binge drinking or heavy alcohol use (male individuals: >5 drinks within 2 h or on any day, or >15 drinks per week; female individuals: >4 drinks within 2 h or on any day or >8 drinks per week), illicit substance use (eg, anything besides alcohol or cannabis to get high), or operation of a motor vehicle within 3 hours of consuming a psychoactive substance. The study team will request clinician confirmation that the notification was received and will follow up as needed. Additionally, confidentiality will be breached in the unlikely event that the participant spontaneously discloses a serious and imminent risk to their safety (eg, suicidality), in which case they will be directly connected with an on-call clinician for standard clinical care. Whether and how the clinician addresses the safety concern with their participating patient will be at the clinician’s discretion and is outside the scope of the study team.

This paper follows the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials; Checklist 1) reporting guidelines for randomized trials [81], as well as the guidelines for web-based and mHealth interventions [82]. The study was approved by the hospital Institutional Review Board (IRB-P00049240) and registered on ClinicalTrials.gov (NCT06661031) in October 2024. Protocol amendments will undergo Institutional Review Board approval and will be reported to the National Institute on Drug Abuse as appropriate. The research assistant will facilitate an electronic informed consent process with comprehension checks about study activities, risks, benefits, and confidentiality. Participants will be remunerated up to US $260 in e-gift cards, prorated based on completion of study activities. Payment will be based solely on completion of study activities and will not be contingent on cannabis use, abstinence, or any other outcome. Participation in the study is voluntary, and participants may choose to leave the study at any time. Advisory board members will be offered a US $50 e-gift card per meeting.

For this pilot feasibility trial, we will enroll 60 patients, whom we will randomize 1:1 to MOMENT-V vs EUC. As our goal is feasibility testing, a sample size calculation is not required. A sample of 60 participants is large enough to describe feasibility constructs. Specifically, for a key measure of trial feasibility, retention, we will be able to estimate a trial retention rate at 3-month follow-up of 80% in a sample of 60 to within a 95% CI of ±10%, that is, 70%-90%, calculated as 1.96 × the square root of [p×(1 p)/n], where p is the percentage retention that we expect to see and n is the intended sample size. Retention efforts will include bimonthly participation reminders, a birthday text, and respectful remuneration.

At the first visit, after completing the baseline assessments, participants will be randomly assigned 1:1 to MOMENT-V vs EUC. Treatment allocation is concealed using a computer-generated urn randomization list via the REDCap (Vanderbilt University) randomization module, which is accessible only to the study biostatistician. Randomization will balance groups by participant factors that may influence study outcomes. Specifically, assignment will be 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 recruitment site. Because of the urn randomization algorithm, future assignments cannot be predicted from previous allocations. In addition, study personnel responsible for participant enrollment do not have access to future assignments, preventing prediction of upcoming allocations. The condition will not be masked to participants, study counselors, or research assistants. The condition will be masked to the biostatistician via a numeric binary code.

All self-administered surveys will be hosted in REDCap, a HIPAA (Health Insurance Portability and Accountability Act)-compliant platform [83,84]. Validation techniques will be programmed (eg, branching logic, valid numeric ranges, and so on). We will operate under a National Institutes of Health (NIH) Certificate of Confidentiality and use methods to further protect confidentiality and privacy, including assigning a unique numeric study ID to each participant in lieu of storing survey responses with personal information. Data will be exported and stored in a secure, restricted-access location on the hospital’s file network.

The principal investigator will oversee implementation of the study’s data and safety monitoring plan to ensure data integrity and security. Because this is a feasibility trial, there are no plans for interim analyses or stopping rules.

Using mixed methods and a pilot randomized trial design, this study will provide evidence of the feasibility and preliminary efficacy of the MOMENT-V telehealth-plus-EMI intervention to reduce cannabis use among young adults with CUD who are seen in primary care settings. The study will also provide evidence of the feasibility of the remote trial procedures in anticipation of a future fully powered efficacy trial of the MOMENT-V intervention vs EUC.

The MOMENT-V intervention has been developed based on a solid conceptual framework, best practices for behavior change counseling, empirical data, and young adult input. This study will use recommended methods to evaluate feasibility; we will collect data on multiple validated and standardized measures and compare the results with a priori benchmarks. Data will be collected electronically, and rigorous procedures to monitor counselor fidelity and ensure data quality will be used. A pilot test of MOMENT-V provided preliminary evidence that young adults with CUD engaged with the intervention and found it helpful [53].

This study may be limited by challenges with recruitment and retention owing to factors outside our control, such as clinic or participant disengagement or competing demands. We will make every effort to support successful recruitment by using inclusive, prominently displayed recruitment materials, developed with input from young adult and community advisors, and by maintaining ongoing communication with clinic staff regarding recruitment and study progress. The research team will meet weekly to review enrollment and promptly identify and address issues. We will mitigate attrition by implementing a detailed informed consent process, offering respectful remuneration, collecting extensive locating information, maintaining frequent contact, and using appealing methods, in addition to conducting all study activities remotely. To further support study engagement, we will invite participant feedback on surveys and in an interview. We will optimize intervention completion and EMI engagement by scheduling MET sessions and report prompts around work/school schedules and sleep hours and by sending text reminders about participation. Participants will not be blinded to their study condition, which may influence their satisfaction ratings, retention, and other outcomes. Because participation is voluntary, the results may not be generalizable to young adults with CUD who are not seeking treatment or not motivated to participate in research.

The growing public health crisis of CUD [88] in young adults mandates the availability of evidence-based, developmentally appropriate, accessible, affordable, and practical treatment that will be acceptable to patients and clinicians alike. By combining telehealth MET with mHealth EMI, the innovative and scalable MOMENT-V offers a brief fully remote approach for implementation within primary care, addressing many treatment barriers for the vulnerable and underserved population of young adults with CUD. Should the MOMENT-V intervention and procedures prove feasible in this rigorous randomized pilot trial, a large trial will be warranted to evaluate the intervention’s efficacy and advance much-needed research on CUD treatment for young adults.