Suvorexant for Cannabis Use Disorder

Overseen By Julia Jashinski, MSW

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Must be taking: Suvorexant

Must not be taking: CYP3A inhibitors/inducers, Digoxin

Disqualifiers: Unstable illness, Neurological disorders, Obesity, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 14 days

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to observe the impact of suvorexant, sold as BELSOMRA, on brain activity of people who frequently use cannabis. Suvorexant is an FDA-approved medication to treat insomnia. Researchers think that suvorexant may reduce activity in certain parts of the brain associated with cannabis use. Researchers are studying if this medication does affect brain activity in these areas. For this study, participants will be asked to complete four study visits over approximately 14 days. Each study visit will include interviews, questionnaires, and collection of biological samples for laboratory testing. All participants will be asked to take suvorexant, an FDA approved medication for treatment of insomnia, for 14 days. They will complete two one-hour functional Magnetic Resonance Imaging (fMRI) scans: one before starting the study medication and one after 14 days of taking the study medication. MRI is used in typical medical settings and is considered to be safe. Participants will also be asked to complete a short daily survey for approximately 14 days.

Research Team

Jodi M Gilman, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults aged 18-60 who use cannabis almost every day and have been doing so for at least a year. They must meet the criteria for Cannabis Use Disorder, be able to understand English, and women of childbearing age need a negative pregnancy test.

Inclusion Criteria

Meet criteria for cannabis use disorder (CUDIT-R scores >12)

Be able to read, speak, and understand the English language. English can be a second language, provided that the subject understands all the questions used in the assessment measures.

I have been using cannabis almost every day for the past year.

Exclusion Criteria

I have never had a major head injury that affected my brain function.

I do not have any severe, unstable health or mental conditions.

Presence of metallic foreign bodies such as cardiac pacemakers, perfusion pumps, aneurysm clips, metallic tattoos anywhere on the body, tattoos near the eye

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take suvorexant for 14 days, with fMRI scans before and after treatment

14 days

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue taking suvorexant for up to 14 additional days if the second fMRI scan is delayed

14 days

Treatment Details

Interventions

• Suvorexant

Trial Overview The study tests if Suvorexant (BELSOMRA), an insomnia medication, affects brain activity related to cannabis use. Participants will take the drug daily for two weeks and undergo two fMRI scans—one before starting the medication and one after—to monitor changes.

Participant Groups

Group I: Open-Label Suvorexant Experimental Treatment 1 Intervention

Participants will complete study visits at Day 0 (Baseline, V2), Day 7 (V3), and Day 14 (V4). After completing a baseline pre-treatment fMRI scan, participants will begin taking 10 mg of suvorexant once daily by mouth in the evening on days 1-3, 15 mg once daily by mouth in the evening on days 4-6, and 20 mg once daily by mouth in the evening on day 7 through the remainder of the study. On day 14, participants will complete a post-treatment fMRI scan. Participants will be treated for 14 days in total; however, due to scanner availability, the second scan may occur more than 14 days after the first scan. In this case, participants will be allowed to continue taking this dose for up to 14 additional days until the final scan occurs (28 days total).

Suvorexant is already approved in United States, Japan for the following indications:

Approved in United States as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Approved in Japan as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+