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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06584942
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cannabis Use Disorder
  • Cue-reactivity
  • Functional MRI
  • Orexin Antagonist

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Suvorexant — DRUG
    Subjects will titrate up to 20 mg of suvorexant daily. Subjects will follow a titration schedule with 10 mg once daily on days 1-3, 15 mg once daily on days 4-6, then 20 mg on day seven and for the remainder of the study. If participants report AEs (worsening depression/suicidal ideation, complex sleep behaviors, sleep paralysis, etc.) dose may be decreased to the previous dose taken. 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).

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Open-Label Suvorexant
    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).

Primary Outcome Measure

Change in Insula Activation to Cannabis Cues During a Cue Reactivity Task Measured by fMRI [ Time Frame: Baseline, Day 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Addiction Medicine, Massachusetts General HospitalBostonMassachusetts02114
Jodi M Gilman, PhD
[email protected]
617-643-7293

Find similar trials in Boston, MA

By research site
Center for Addiction Medicine, Massachusetts General Hospital· Boston, MA

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