Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder

NCT06584942 Phase 4 RECRUITING

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.

Details

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	RECRUITING
Enrolment	20
Start date	2025-03-10
Completion	2026-07

Conditions

• Cue-reactivity
• Cannabis Use Disorder
• Functional MRI
• Orexin Antagonist

Interventions

• Suvorexant

Primary outcomes

• Change in Insula Activation to Cannabis Cues During a Cue Reactivity Task Measured by fMRI — Baseline, Day 14
  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.

Countries

United States