Status:
RECRUITING
Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Massachusetts Institute of Technology
Conditions:
Cue-reactivity
Cannabis Use Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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. Re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Participants cannot have an acutely unstable medical or psychiatric illness
- Medications with the potential to depress CNS function will be assessed by the PI or study physician and participants will be excluded as necessary
- Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders
- Presence of metallic foreign bodies such as cardiac pacemakers, perfusion pumps, aneurysm clips, metallic tattoos anywhere on the body, tattoos near the eye
- Individuals with severe hepatic impairment will be excluded
- Participants cannot be obese as determined by a Body Mass Index (BMI) or greater than 35
- Participants cannot be using a CYP3A inhibitor/inducer (metabolism by CYP3A is the major elimination pathway for suvorexant)
- Participants cannot have a current cardiac disorder such as palpitations, tachycardia, and/or the use of the cardiac medication Digoxin
- Participants cannot have narcolepsy
- Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food, or making phone calls
- Participants cannot be actively suicidal (current suicidal ideation with specific plan or intent) and/or report a suicide attempt or psychiatric hospitalization in the past year
- Participants cannot have a current substance use disorder based on a DSM-V diagnosis and MINI Interview for Substance Use Disorders other than nicotine and cannabis and cannot meet criteria for moderate or severe alcohol use disorder
- Pregnancy or breastfeeding: a negative pregnancy test is required at the enrollment visit
- In the opinion of the investigators, not able to complete study procedures or safely participate in the study
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06584942
Start Date
March 10 2025
End Date
December 1 2025
Last Update
May 18 2025
Active Locations (1)
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1
Center for Addiction Medicine, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114