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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called suvorexant, which is commonly used to treat insomnia, on the brain activity of people who frequently use cannabis. The researchers believe that suvorexant may help reduce certain brain responses linked to cannabis use, and they want to see if this medication can make a difference. If you're between the ages of 18 and 60, use cannabis nearly every day for at least a year, and meet certain health criteria, you might be eligible to participate in this study.

Participants will take suvorexant for 14 days and will need to attend four study visits. During these visits, you'll fill out questionnaires, have interviews, and undergo two MRI scans to assess brain activity—one before starting the medication and one after two weeks. The MRI is a safe imaging test often used in hospitals. Additionally, you'll complete a short daily survey on your mobile device throughout the study. If you're interested in participating, keep in mind that there are specific health conditions that could exclude you from the study, so it's important to discuss your medical history with the study team.

Gender

ALL

Eligibility criteria

• 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 surveys
• Exclusion Criteria:
• • 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