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Orexin Receptor Antagonist

Open label trial of suvorexant in individuals with alcohol use disorder for Cushing's Syndrome (Suvsubuse Trial)

Phase 2 & 3
Waitlist Available
Led By Venkatesh Basappa Krishnamurthy, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Suvsubuse Trial Summary

This trial will determine if the orexin 1 / 2 receptor antagonist suvorexant decreases sleep disturbance and drug craving in patients with substance use disorders (SUDs), and if it has the potential to reduce relapse rates.

Eligible Conditions
  • Cushing's Syndrome
  • Craving
  • Sleep Disorder

Suvsubuse Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Total Sleep Time as Measured by Actigraphy and Sleep Logs Relative to Baseline Over the Course of 7 Days of Treatment With Suvorexant in Substance Use Disorder Patients.
Secondary outcome measures
Change in Scale Items on a Modified Abuse Liability Assessment Battery Relative to Baseline.
Relative to a Baseline, Change in Daily Reports of Craving Using Ecological Momentary Assessment (EMA Data) Over the Course of 7 Days of Treatment With Suvorexant in Substance Use Disorder Patients.
Relative to a Baseline, Change in Total Daily Salivary Cortisol Over the Course of 7 Days of Treatment With Suvorexant in Substance Use Disorder Patients.

Suvsubuse Trial Design

2Treatment groups
Experimental Treatment
Group I: Open label trial of suvorexant in individuals with opioid use disorderExperimental Treatment1 Intervention
It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder.
Group II: Open label trial of suvorexant in individuals with alcohol use disorderExperimental Treatment1 Intervention
It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant 20 mg
2019
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,794 Total Patients Enrolled
Venkatesh Basappa Krishnamurthy, MDPrincipal InvestigatorPenn State University Hershey Medical Center

Media Library

Suvorexant (Orexin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03412591 — Phase 2 & 3
Cushing's Syndrome Research Study Groups: Open label trial of suvorexant in individuals with alcohol use disorder, Open label trial of suvorexant in individuals with opioid use disorder
Cushing's Syndrome Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT03412591 — Phase 2 & 3
Suvorexant (Orexin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03412591 — Phase 2 & 3

Frequently Asked Questions

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

Are there any unfilled vacancies for participants in this experiment?

"Unfortunately, this study is not recruiting at the moment. Although, it's worth noting that the trial was most recently updated on July 12th, 2022 and originally posted on July 1st, 2019. If you're looking for similar studies, 516 trials are currently enrolling patients with cravings and 14 are seeking participants for this treatment."

Answered by AI

Are people over the age of 35 eligible to participate in this trial?

"As long as potential patients are aged between 21 and 64, they will be eligible for this clinical trial."

Answered by AI

How many people are being treated with this experimental medication?

"Unfortunately, this particular trial is no longer searching for patients to enroll. Although, if you are still interested in participating in a study, there are 516 other trials actively looking for participants with your condition and 14 other studies testing this treatment that are also currently recruiting."

Answered by AI

Is this a new or innovative treatment, or has it been studied before?

"There are currently 14 ongoing clinical trials testing this potential treatment. Out of these, 2 have progressed to Phase 3. The vast majority of trial locations for this study are situated in Silver Spring, Maryland; however, there are 71 total sites running these experiments."

Answered by AI

Who meets the eligibility requirements for this clinical trial?

"This trial is looking for 28 participants who have cravings and meet the following criteria: Caron Foundation residential alcohol or opioid dependent patients that have a history of daily or near daily substance use for the month prior to admittance, Group 2: at least five days post medically assisted withdrawal for opioid dependence and complain of problems falling asleep, remaining asleep after sleep onset, or poor sleep quality on current sleep medication (antidepressant/melatonin), Sex: male or female, Age: 21-64 (inclusive) years old."

Answered by AI
~5 spots leftby Apr 2025