← Back to Search

Suvorexant for Opioid Use Disorder

Phase 2
Recruiting
Led By Andrew S Huhn, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Achieving a study maintenance dose of >=8mg sublingual buprenorphine/naloxone
Aged 18-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 nights during the initial residential phase and 1 night at the end of outpatient treatment
Awards & highlights

Study Summary

This trial will test if suvorexant, a medication that helps with sleep, is better than placebo in people with opioid use disorder who have recently been exposed to fentanyl.

Who is the study for?
This trial is for adults aged 18-65 with opioid use disorder, specifically those who have used fentanyl recently. Participants must be interested in buprenorphine treatment for their condition and able to follow the study's rules. They should not have significant medical conditions that could interfere with the trial, nor plans to move away during the study period.Check my eligibility
What is being tested?
The trial tests if suvorexant helps people with opioid use disorder when added to buprenorphine therapy compared to a placebo. It starts with a 5-day stay where participants stabilize on buprenorphine/naloxone, followed by a 3-week outpatient phase including extended-release buprenorphine.See study design
What are the potential side effects?
Suvorexant may cause drowsiness, headaches, dizziness, dry mouth or abnormal dreams. Since it's being tested alongside buprenorphine (which can also cause side effects like nausea and constipation), monitoring will be important.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am taking a maintenance dose of 8mg or more of sublingual buprenorphine/naloxone.
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 nights during the initial residential phase and 1 night at the end of outpatient treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 nights during the initial residential phase and 1 night at the end of outpatient treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment
Total Sleep Time

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SuvorexantExperimental Treatment1 Intervention
Nightly dosing of suvorexant
Group II: PlaceboPlacebo Group1 Intervention
Nightly dosing of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
2016
Completed Phase 4
~2120

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,289 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,045 Total Patients Enrolled
Andrew S Huhn, Ph.D.Principal InvestigatorJohns Hopkins University

Media Library

Suvorexant Clinical Trial Eligibility Overview. Trial Name: NCT05145764 — Phase 2
Opioid Use Disorder Research Study Groups: Suvorexant, Placebo
Opioid Use Disorder Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT05145764 — Phase 2
Suvorexant 2023 Treatment Timeline for Medical Study. Trial Name: NCT05145764 — Phase 2
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT05145764 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for the clinical trial?

"Affirmative. Clinicaltrials.gov's data establishes that this research, which initially went live on March 30th 2022, is actively recruiting individuals. A total of 120 participants must be sourced from a single medical centre."

Answered by AI

Does this clinical trial offer me the opportunity to participate?

"This medical study seeks 120 patients between 18 and 65 years old who are using suvorexant. Candidates must also promise to remain in the same locale for the duration of the trial, agree with all protocol conditions, and not have any significant chronic disorders that would impede their ability to be involved."

Answered by AI

Has Suvorexant been studied previously in other research projects?

"Currently, 14 clinical trials concerning Suvorexant are in progress with 2 Phase 3 tests. These experiments primarily take place at the Silver Spring, Maryland facility but there are 71 medical research sites worldwide partnering with this project."

Answered by AI

Could taking Suvorexant be potentially hazardous for patients?

"Suvorexant's safety was rated a 2 due to the limited evidence available from Phase 2 trials; while some data points towards its safety, there is no proof of efficacy."

Answered by AI

Is there an age threshold for participants of this research trial?

"This particular medical trial requires that participants are between 18-65 years of age. Alternatively, there are 22 studies aimed at minors and 252 trials targeting seniors over the age of 65."

Answered by AI

How many patients is the research team recruiting for this trial?

"That is accurate. Per the information on clinicaltrials.gov, this medical experiment was first announced on March 30th 2022 and is still open to applicants today. The study requires 120 participants to enroll from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins Bayview Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have been in recovery for 8 months and completed another study recently and would love to help with addiction struggles and be a part of help to improve recovery chances.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Johns Hopkins Bayview Medical Center: < 48 hours
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
2022. "Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05145764.
All > Belsomra
~34 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top