Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder
Massachusetts General Hospital
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
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 surv…
Interventions
- DrugSuvorexant
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).
Location
- Center for Addiction Medicine, Massachusetts General HospitalBoston, Massachusetts