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

65 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the MOMENT-V treatment for cannabis use disorder?

Research shows that digital interventions, like smartphone apps and computer-assisted therapies, can help reduce cannabis use. These methods are accessible and can be as effective as traditional therapy, making them a promising option for treating cannabis use disorder. ^{1 2 3 4 5}

Is the Telehealth + MHealth Intervention for Cannabis Use Disorder safe for humans?

Research on digital interventions for cannabis use, including telehealth and mobile health (MHealth) approaches, suggests they are generally safe for humans. These interventions have been used to help reduce cannabis use and are considered a promising option for treatment, with broad acceptance and regulatory changes supporting their use. ^{2 5 6 7 8}

What makes the MOMENT-V Intervention treatment unique for cannabis use disorder?

The MOMENT-V Intervention is unique because it combines telehealth and mobile health (mHealth) technologies to provide real-time, personalized support and motivational messaging, which can be more engaging and accessible for users compared to traditional in-person treatments. This approach allows for interventions to occur in the real-life contexts where cannabis use happens, potentially increasing its effectiveness. ^{2 7 9 10 11}

Eligibility Criteria

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

I use cannabis recreationally more than 3 days a week.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Systematic review of outcome domains and measures used in psychosocial and pharmacological treatment trials for cannabis use disorder. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Short- and long-term effects of digital prevention and treatment interventions for cannabis use reduction: A systematic review and meta-analysis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Can a Smartphone App for Cannabis Cessation Gain a Broader User Group than Traditional Treatment Services? [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

An initial trial of a computerized behavioral intervention for cannabis use disorder. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Associations of cannabis use frequency and cannabis use disorder with receiving a substance use screen and healthcare professional discussion of substance use. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Assessment of cannabis use disorders: a systematic review of screening and diagnostic instruments. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Effects of Treatment Length and Chat-Based Counseling in a Web-Based Intervention for Cannabis Users: Randomized Factorial Trial. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Applications of technology in the assessment and treatment of cannabis use disorder. [2022]

9. England pubmed.ncbi.nlm.nih.gov

"Counselor in Your Pocket": Youth and Provider Perspectives on a Mobile Motivational Intervention for Marijuana Use. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A pilot trial of text-delivered peer network counseling to treat young adults with cannabis use disorder. [2021]

11. United States 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. [2023]