Evaluating the effects of suvorexant on brain activity in cannabis users
Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder
PHASE4 · Massachusetts General Hospital · NCT06584942
This study is testing if the insomnia medication suvorexant can help reduce brain activity related to cannabis cravings in people who have a cannabis use disorder.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06584942 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess how suvorexant, an FDA-approved insomnia medication, influences brain activity in individuals with cannabis use disorder. Participants will undergo four visits over 14 days, during which they will take suvorexant and complete interviews, questionnaires, and biological sample collections. The study includes two functional MRI scans to measure brain reactivity before and after the treatment period. The goal is to determine if suvorexant can reduce brain activity linked to cannabis cues.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 who use cannabis daily or nearly daily and meet the criteria for cannabis use disorder.
Not a fit: Patients with acutely unstable medical or psychiatric conditions or those with a history of major head trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals struggling with cannabis use disorder by potentially reducing their brain's reactivity to cannabis-related cues.
How similar studies have performed: While the specific use of suvorexant for cannabis use disorder is novel, similar studies have explored the effects of orexin antagonists on addiction-related behaviors.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Center for Addiction Medicine, Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Jodi M Gilman, PhD — Massachusetts General Hospital
- Study coordinator: Jodi M Gilman, PhD
- Email: jgilman1@mgh.harvard.edu
- Phone: 617-643-7293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cue-reactivity, Cannabis Use Disorder, Functional MRI, Orexin Antagonist, Cannabis use, fMRI