Cue-reactivityPhase 4NCT06584942
Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study)
A Phase 4 study testing Suvorexant in people with Cue-reactivity and Cannabis Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cue-reactivity, Cannabis Use Disorder, Functional MRI
- What is being tested?
- Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 11 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Addiction Medicine, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder
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.
- Being tested
- Suvorexant
- Keywords
- Cannabis use, fMRI, Cue-reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Subjects will titrate up to 20 mg of suvorexant daily. Subjects will follow a titration schedule with 10 mg once daily on days 1-3, 15 mg once daily on days 4-6, then 20 mg on day seven and for the remainder of the study. If participants report AEs (worsening depression/suicidal ideation, complex sleep behaviors, sleep paralysis, etc.) dose may be decreased to the previous dose taken. Participants will be treated for 14 days in total; however, due to scanner availability, the second scan may occur more than 14 days after the first scan. In this case, participants will be allowed to continue taking this dose for up to 14 additional days until the final scan occurs (28 days total).
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Suvorexant | Experimental | Participants will complete study visits at Day 0 (Baseline, V2), Day 7 (V3), and Day 14 (V4). After completing a baseline pre-treatment fMRI scan, participants will begin taking 10 mg of suvorexant once daily by mouth in the evening on days 1-3, 15 mg once daily by mouth in the evening on days 4-6, and 20 mg once daily by mouth in the evening on day 7 through the remainder of the study. On day 14, participants will complete a post-treatment fMRI scan. Participants will be treated for 14 days in total; however, due to scanner availability, the second scan may occur more than 14 days after the first scan. In this case, participants will be allowed to continue taking this dose for up to 14 additional days until the final scan occurs (28 days total). Receives: Drug: Suvorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insula Activation to Cannabis Cues During a Cue Reactivity Task Measured by fMRI
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.
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start10 Mar 2025
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cue-reactivityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single-group pilot study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Jodi Gilman, Massachusetts General Hospital
- Investigators
- Jodi M Gilman, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584942
- Sponsor's protocol ID
- 2024P002380
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT06584942
- Acronym / sponsor ID
- 2024P002380
- Keywords
- Cannabis use, fMRI, Cue-reactivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single-group pilot study.
| Arm | Type | Receives |
|---|---|---|
| Open-Label Suvorexant | Experimental | Drug: SuvorexantParticipants will complete study visits at Day 0 (Baseline, V2), Day 7 (V3), and Day 14 (V4). After completing a baseline pre-treatment fMRI scan, participants will begin taking 10 mg of suvorexant once daily by mouth in the evening on days 1-3, 15 mg once daily by mouth in the evening on days 4-6, and 20 mg once daily by mouth in the evening on day 7 through the remainder of the study. On day 14, participants will complete a post-treatment fMRI scan. Participants will be treated for 14 days in total; however, due to scanner availability, the second scan may occur more than 14 days after the first scan. In this case, participants will be allowed to continue taking this dose for up to 14 additional days until the final scan occurs (28 days total). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuvorexantSubjects will titrate up to 20 mg of suvorexant daily. Subjects will follow a titration schedule with 10 mg once daily on days 1-3, 15 mg once daily on days 4-6, then 20 mg on day seven and for the remainder of the study. If participants report AEs (worsening depression/suicidal ideation, complex sleep behaviors, sleep paralysis, etc.) dose may be decreased to the previous dose taken. Participants will be treated for 14 days in total; however, due to scanner availability, the second scan may occur more than 14 days after the first scan. In this case, participants will be allowed to continue taking this dose for up to 14 additional days until the final scan occurs (28 days total). | Drug | Open-Label Suvorexant |
Primary outcome
Change in Insula Activation to Cannabis Cues During a Cue Reactivity Task Measured by fMRI
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodi M Gilman, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suvorexant in people with Cue-reactivity and Cannabis Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insula Activation to Cannabis Cues During a Cue Reactivity Task Measured by fMRI (time frame: Baseline, Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.