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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether suvorexant, a medication typically used for insomnia, can affect brain activity in frequent cannabis users. Researchers aim to determine if suvorexant can reduce activity in brain areas associated with cannabis use. Participants will take suvorexant for 14 days and undergo two brain scans to detect changes. The trial seeks individuals who have used cannabis daily or almost daily for at least a year and meet the criteria for cannabis use disorder. As a Phase 4 trial, suvorexant is already FDA-approved and proven effective, and this research seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are using medications that affect the central nervous system or certain other drugs. It's best to discuss your current medications with the study team.

What is the safety track record for suvorexant?

Research has shown that suvorexant is generally well-tolerated. In one study where participants took suvorexant for a year, only 5% experienced serious side effects. This low percentage suggests that most people do not encounter major issues with the drug. The most common side effects were mild, such as drowsiness. Since the FDA approved suvorexant for treating insomnia, it has maintained a well-established safety record. This approval indicates its overall safety for treating sleep problems in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Suvorexant is unique because it targets the orexin system, which plays a role in regulating sleep and wakefulness. Unlike traditional treatments for cannabis use disorder, which often focus on behavioral therapy or medications that manage withdrawal symptoms, suvorexant offers a novel approach by potentially addressing sleep disturbances that are common in individuals with cannabis use disorder. Researchers are excited about suvorexant's potential not only because it offers a different mechanism of action but also because it could provide quicker relief from sleep-related issues, a significant challenge for people trying to quit cannabis.

What evidence suggests that suvorexant might be an effective treatment for cannabis use disorder?

Research shows that suvorexant, a medication approved for treating insomnia, might help reduce brain activity related to cannabis use. Earlier studies found that suvorexant improves sleep and eases withdrawal symptoms in people reducing opioid use. Although intended for sleep problems, researchers believe it might aid in cannabis use disorder by calming certain brain areas. This calming effect might reduce the urge to use cannabis. While more research is needed specifically for cannabis use, its success in other conditions is promising. Participants in this trial will receive suvorexant to explore its potential benefits for cannabis use disorder. ^{1 3 4 6 7}

Who Is on the Research Team?

Jodi M Gilman, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06655883

NCT06655883 | A Study of Suvorexant (MK-4305) for the ... Participants receive 10 mg of suvorexant for the first three nights, increased to 20 mg of suvorexant nightly thereafter at the investigator's discretion, for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9588557/

Suvorexant maintenance enhances the reinforcing but not ... This study aimed to translate those preclinical findings and determine whether suvorexant maintenance altered the pharmacodynamic effects of cocaine in humans.

3. science.org science.org/doi/10.1126/scitranslmed.abn8238

Suvorexant ameliorated sleep disturbance, opioid ... The results suggest that suvorexant might be a promising treatment for sleep and opioid withdrawal in individuals undergoing a buprenorphine/naloxone taper.

4. massgeneral.trialstoday.org massgeneral.trialstoday.org/trial/NCT06584942

Mass General - Division of Clinical Research The goal of this study is to observe the impact of suvorexant, sold as BELSOMRA, on brain activity of people who frequently use cannabis.

5. hopkinsmedicine.org hopkinsmedicine.org/news/articles/2024/12/improving-sleep-for-those-with-opioid-use-disorder

Improving Sleep for Those with Opioid Use Disorder Finding that suvorexant is safe and effective for the treatment of insomnia in people with OUD could spur the Food and Drug Administration to ...

6. withpower.com withpower.com/trial/phase-4-marijuana-abuse-10-2024-15e91

Suvorexant for Cannabis Use Disorder The goal of this study is to observe the impact of suvorexant, sold as BELSOMRA, on brain activity of people who frequently use cannabis.

7. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(14)70053-5/abstract

Safety and efficacy of suvorexant during 1-year treatment ... Serious adverse events were recorded in 27 patients (5%) who received suvorexant and 17 (7%) who received placebo. The most common adverse event ...