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Orexin Antagonist
Suvorexant for Opioid Use Disorder
Phase 2
Recruiting
Led By Andrew S Huhn, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD
Between the ages of 21-65, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial)
Awards & highlights
Study Summary
This trial is investigating whether the orexin neurotransmitter system is linked to sleep disturbance and stress in opioid use disorder patients who are early in their recovery and on medication assisted treatment.
Who is the study for?
This trial is for adults aged 21-65 with opioid use disorder who are in early recovery and experiencing sleep disturbances. They must be on medication-assisted treatments like methadone, buprenorphine, or XR-NTX, have abstained from illicit opioids for two weeks, and agree to weekly visits and daily monitoring. Exclusions include unstable serious mental illnesses, other severe substance disorders, certain medication allergies or uses, pregnancy/breastfeeding, specific sleep disorders like narcolepsy or severe apnea.Check my eligibility
What is being tested?
The study tests whether suvorexant can improve sleep and reduce stress-related relapse behaviors in patients recovering from opioid addiction compared to a placebo. Participants maintained on different medications (methadone/buprenorphine/XR-NTX) will randomly receive either suvorexant or a placebo while their sleep patterns and stress levels are monitored.See study design
What are the potential side effects?
Suvorexant may cause drowsiness during the day, headaches, dizziness when standing up too fast due to low blood pressure (orthostatic hypotension), unusual dreams or nightmares; less commonly it might lead to temporary muscle weakness (cataplexy) or an allergic reaction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently in a treatment program for opioid use disorder.
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I am between 21 and 65 years old.
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I have had trouble sleeping in the past month.
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I have had trouble sleeping in the past month.
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I am willing to follow a specific medication plan with methadone or XR-NTX for the study.
Select...
I am willing to follow a specific medication plan for the study.
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I am between 21 and 65 years old.
Select...
I am currently in a treatment program for opioid use disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Perceived Stress Scale 4 (PSS-4) score
Total Sleep Time
Total Wake Time After Sleep Onset
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: SuvorexantActive Control1 Intervention
Sleep medication (20mg suvorexant; 2 10mg capsules; patients can self-titrate to 1 10mg capsule)
Group II: PlaceboPlacebo Group1 Intervention
Placebo sleep medication (2 placebo oral capsules)
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,273 Previous Clinical Trials
14,840,192 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,326 Total Patients Enrolled
Andrew S Huhn, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking steroids or medications that affect my hormone control system.I have been diagnosed with narcolepsy, sleep paralysis, or restless leg syndrome.You have shown signs of wanting to harm yourself in the past month, as evaluated by a specific questionnaire.I have been prescribed suvorexant in the last 30 days.You have a moderate to severe problem with using drugs or alcohol, other than opioid use disorder.I am between 21 and 65 years old.I am willing to follow the study rules, including weekly visits and daily assessments.I am currently taking medication for sleep that is classified as schedule IV.You have a serious mental illness that is not stable and may affect your ability to take part in the study. This includes conditions like hearing things that aren't there, having strong beliefs that are not true, and thinking about hurting yourself or others.I have had trouble sleeping in the past month.I am not taking any medications that affect Cytochrome P450 3A.I have had trouble sleeping in the past month.I am willing to follow the study's rules, including weekly visits and daily assessments.I am currently in a treatment program for opioid use disorder.You are currently using illegal stimulant drugs like cocaine or methamphetamine.You have not used illegal opioids for at least two weeks, as confirmed by your self-report and urine tests.I am willing to follow a specific medication plan with methadone or XR-NTX for the study.I am willing to follow a specific medication plan for the study.You must not have used illegal opioids for at least two weeks, as confirmed by your own report and urine tests.I am between 21 and 65 years old.You stop breathing or have shallow breathing more than 30 times per hour during sleep.I am currently in a treatment program for opioid use disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Suvorexant
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to partake in this experiment?
"This clinical trial is in search of 200 individuals between the ages 21 to 65 who have been diagnosed with opioid use disorder. In order for participants to be accepted, they must meet these eligibility criteria."
Answered by AI
Is Suvorexant a risk-free medication for users?
"There is preliminary data that suggests the safety of Suvorexant, therefore this medication received a score of 2."
Answered by AI
What is the maximum capacity of people who can participate in this experiment?
"Affirmative, clinicaltrials.gov has evidence that this clinical experiment is actively seeking volunteers. It was initially posted on November 20th 2020 and recently updated on May 16th 2022. This trial requires 200 individuals to participate from 5 different sites."
Answered by AI
Is this research available to people under thirty years of age?
"The eligibility criteria for this clinical trial dictates that participants should be between 21 to 65 years of age. Separately, there are 121 studies involving patients below the legal voting age and 504 studies which involve seniors above 65."
Answered by AI
Are there any vacancies that participants can fill in this clinical investigation?
"According to the data available on clinicaltrials.gov, this trial is presently recruiting participants; it was first posted in November 2020 and has been recently updated as of May 16th 2022."
Answered by AI
Is there a precedent of Suvorexant being tested in clinical settings?
"Currently, 14 clinical trials are being conducted for Suvorexant with two in their final Phase 3. While the primary research hub is located in Silver Spring, Maryland, 71 other sites have been enlisted to run these studies."
Answered by AI
Who else is applying?
What state do they live in?
Delaware
Maryland
What site did they apply to?
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Ashley Addiction Treatment
Man Alive Inc., Lane Treatment Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Man Alive Inc., Lane Treatment Center: < 48 hours
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