Telehealth + MHealth Intervention for Cannabis Use Disorder

(CAN-DO Trial)

Overseen By Sion K Harris, PhD, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Pregnancy, Parenting, Substance use treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new digital program, MOMENT-V, can help young adults reduce cannabis use. Participants will either use a smartphone app for two weeks and meet with a counselor twice, or meet with a counselor once. The trial will assess the program's usability and effectiveness in reducing cannabis use. It seeks young adults who use cannabis more than three days a week and own a smartphone. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could assist others in reducing cannabis use.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on cannabis use, so it's best to ask the research team for guidance.

What prior data suggests that the MOMENT-V intervention is safe for cannabis use disorder treatment?

Research on digital tools for reducing cannabis use, such as the MOMENT-V, shows they are generally safe. Previous studies found the MOMENT tool practical and well-received, particularly in helping young people reduce marijuana cravings and use. These findings suggest that the MOMENT-V is user-friendly and free of major safety issues. Participants in similar studies experienced no serious side effects, indicating that this type of digital treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MOMENT-V intervention for cannabis use disorder because it combines technology and therapy in a unique way. Unlike standard treatments that might rely solely on counseling or medication, MOMENT-V integrates Motivational Enhancement Therapy sessions with a counselor and two weeks of smartphone-based Ecological Momentary Assessment. This approach not only personalizes the treatment experience but also leverages real-time data from participants’ daily lives to better understand and support their cannabis use reduction journey. By harnessing the power of mHealth, this intervention has the potential to enhance accessibility and engagement, offering a fresh, tech-forward alternative to traditional methods.

What evidence suggests that the MOMENT-V intervention could be effective for cannabis use disorder?

Research has shown that the MOMENT-V program, provided to participants in the intervention arm of this trial, can help young adults reduce their desire to use marijuana. In earlier studies, individuals using this program felt more confident about changing their habits and showed increased motivation to cut down on their use. After two months, many participants improved their marijuana habits. Additionally, more than half of the participants wanted to reduce their marijuana use after just 30 days, with some planning to quit completely. These findings suggest that MOMENT-V could be a helpful tool for young adults seeking to address their marijuana use. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for young adults with cannabis use disorder who were part of the MOMENT-V open pilot, are patients at Boston Children's Hospital Adolescent/Young Adult Medicine Practice, own a smartphone, and can participate for two weeks.

Inclusion Criteria

Ownership of a smartphone that is PIN- or password-protected

I use cannabis recreationally more than 3 days a week.

Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice

Exclusion Criteria

Inability/Unwillingness to provide contact information

For the pilot RCT:

Inability/Unwillingness to provide contact information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MOMENT-V intervention, which includes 2 Motivational Enhancement Therapy sessions and 2 weeks of smartphone-based Ecological Momentary Assessment

3 weeks

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including electronic surveys, interviews, and saliva drug testing

3 months

Multiple virtual check-ins

Long-term Follow-up

Participants continue to be monitored for outcomes such as cannabis use frequency and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MOMENT-V Intervention

Trial Overview The study tests the MOMENT-V intervention—a combination of Motivational Enhancement Therapy and app-based support—against enhanced usual care involving counselor meetings. It aims to see if this can reduce cannabis use in young adults remotely.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

Participants 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 \[EMI\]).

Group II: Enhanced Usual Care arm Experimental Treatment 1 Intervention

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

Group III: Oral fluid test pilot Active Control 1 Intervention

Prior to RCT, single-arm pilot to test feasibility and acceptability of remote oral fluid testing.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Adolescent cannabis use can lead to negative effects on development, cognition, and mental health, making it crucial to address this behavior through effective interventions.

Current strategies for managing cannabis use in adolescents, including screening and brief interventions, show only modest short-term effectiveness, and there are significant limitations in resources for referring adolescents to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance Use Screening, Brief Intervention, and Referral to Treatment in Pediatric Primary Care, School-Based Health Clinics, and Mental Health Clinics. Calihan, JB., Levy, S.[2023]

Cannabis Use Disorder (CUD) is on the rise, and there are currently no FDA-approved medications for its treatment, highlighting a significant gap in available resources for prevention and care.

Ecological momentary assessments (EMA) and technology-based interventions, including digital therapeutics and telehealth, show promise in improving the prevention, screening, and treatment of CUD, especially in light of increased acceptance following the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of technology in the assessment and treatment of cannabis use disorder. Brezing, CA., Levin, FR.[2022]

A combination of motivational enhancement therapy (MET), cognitive-behavioral therapy (CBT), and contingency management (CM) is effective for treating cannabis use disorders, and a computer-assisted version of this treatment shows promise in overcoming barriers to access.

In a 12-week study with 38 adults, both therapist-delivered and computer-delivered treatments resulted in similar attendance and cannabis use outcomes, indicating that computer-assisted therapy is a viable alternative that maintains treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial trial of a computerized behavioral intervention for cannabis use disorder. Budney, AJ., Fearer, S., Walker, DD., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S294987592400184X

Telehealth counseling plus mHealth intervention for ... Behavior change confidence was higher post-intervention and importance and confidence were higher at two months vs. baseline. By two months, 11 participants ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6087802/

Pilot randomized trial of MOMENT, a motivational ... The MOMENT intervention is feasible to deliver, acceptable, and potentially efficacious in reducing marijuana desire and use among adolescent and young adults ...

3. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R34DA060500&arg_ProgOfficeCode=114

Award Information | HHS TAGGS Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults (MOMENT-V) - Daily cannabis use among young adults aged 18-26 years is at ...

4. researchgate.net researchgate.net/publication/378644101_144_Pilot_Study_of_a_Telehealth_Mhealth_Cannabis_Use_Intervention_for_Young_Adults_MOMENT-V

144. Pilot Study of a Telehealth + Mhealth Cannabis Use ... Over half (58.9%) aimed to reduce their use after the 30-day break, while 24.4% intended to quit entirely. Conclusions: This mobile health ...

5. withpower.com withpower.com/trial/phase-marijuana-abuse-11-2024-2519c

Telehealth + MHealth Intervention for Cannabis Use ... What data supports the effectiveness of the MOMENT-V treatment for cannabis use disorder? Research shows that digital interventions, like smartphone apps and ...

6. reporter.nih.gov reporter.nih.gov/project-details/11176996

Project Details - NIH RePORTER This project will use rigorous quantitative and qualitative methods to test the feasibility and preliminary efficacy of MOMENT-V, a novel, fully-remote ...

7. sciencedirect.com sciencedirect.com/org/science/article/pii/S2291522219000706

End User–Informed Mobile Health Intervention ... The rates of cannabis use continue to increase among adolescents and the current interventions have modest effects and high rates of relapse ...