Actively Recruiting

Phase 4
Age: 18Years - 60Years
All Genders
NCT06584942

Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study)

Led by Massachusetts General Hospital · Updated on 2026-01-20

20

Participants Needed

1

Research Sites

68 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

M

Massachusetts Institute of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study)

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-60 years, inclusive
  • Use cannabis daily or near daily and have been using cannabis consistently for at least the past year, by self-report
  • Meet criteria for cannabis use disorder (CUDIT-R scores greater than or equal to 8)
  • Female participants of childbearing potential must have a negative pregnancy test at the enrollment visit
  • Be able to read, speak, and understand the English language
  • Access to a mobile device to complete daily surveys
Not Eligible

You will not qualify if you...

  • Have an acutely unstable medical or psychiatric illness
  • Use medications that may depress CNS function as determined by the study physician
  • History of major head trauma causing cognitive impairment, seizures, or other neurological disorders
  • Presence of metallic foreign bodies such as pacemakers, perfusion pumps, aneurysm clips, or metallic tattoos near the eye
  • Severe hepatic impairment
  • Obesity with Body Mass Index (BMI) greater than 35
  • Use of CYP3A inhibitors or inducers
  • Current cardiac disorders such as palpitations, tachycardia, or use of Digoxin
  • Diagnosis of narcolepsy
  • Self-reported complex sleep behaviors like sleep driving or sleep-related eating
  • Active suicidal ideation with plan or intent, or suicide attempt or psychiatric hospitalization in the past year
  • Current substance use disorder other than nicotine and cannabis, or moderate/severe alcohol use disorder
  • Pregnancy or breastfeeding without a negative pregnancy test at enrollment
  • Unable to safely complete study procedures as judged by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Center for Addiction Medicine, Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

J

Jodi M Gilman, PhD

CONTACT

J

Julia Jashinski, MSW

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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