Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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. English can be a second language, provided that the subject understands all the questions used in the assessment measures.

• Access to a mobile device to complete daily surveys

Locations
United States
Massachusetts
Center for Addiction Medicine, Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Jodi M Gilman, PhD
jgilman1@mgh.harvard.edu
617-643-7293
Backup
Julia Jashinski, MSW
jjashinski@mgh.harvard.edu
617-643-1984
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 10
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Massachusetts Institute of Technology

This content was sourced from clinicaltrials.gov