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NCT06584942 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study)
A Phase 4 study of Cannabis Use Disorder and Orexin Antagonist, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06584942: Recruiting Phase 4 study of Cannabis Use Disorder and Orexin Antagonist, sponsored by Massachusetts General Hospital.
NCT06584942 is a Phase 4 study of Cannabis Use Disorder and Orexin Antagonist that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 109-participant average among 34 other Cannabis Use Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06584942, a Phase 4 study of Cannabis Use Disorder and Orexin Antagonist, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This task will measure brain reactivity to cannabis vs. neutral images. A whole-brain fixed-effects general linear model (GLM) will be run using image regressors (cannabis, neutral images) and motion confound regressors. Beta maps comparing cannabis with neutral images will be created for each subject. Multiple comparisons will be FDR corrected. Beta weights for the cannabis image \> neutral image contrasts will be extracted from the anterior insula across all voxels within each ROI.
Conditions Studied
Interventions
- DRUG Suvorexant
Study Locations (1)
Massachusetts
- Center for Addiction Medicine, Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-03-10 |
| Est. Completion | 2026-07 |
| Phase | Phase 4 |
What NCT06584942 shows while recruiting
NCT06584942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 109-participant average among 34 other Cannabis Use Disorder trials with a reported enrollment target (82% lower).
The record links to 4 conditions, with Cannabis Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Suvorexant is the first listed.
NCT06584942 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06584942 about?
NCT06584942 is a clinical study titled "Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study)". 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 ca...
What is the current status of trial NCT06584942?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2025-03-10. Estimated completion is 2026-07.
What conditions does trial NCT06584942 study?
This clinical trial studies the following conditions: Cannabis Use Disorder, Orexin Antagonist, Cue-reactivity, Functional MRI.
What interventions are being tested in trial NCT06584942?
The interventions under investigation include: Suvorexant (DRUG).
Who is sponsoring clinical trial NCT06584942?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06584942 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cannabis Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06584942's enrollment target sits among peer trials
20 30th of 34 higher than 5 of 34 other Cannabis Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cannabis Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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