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Orexin Receptor Antagonist

Suvorexant for Alcoholism

Phase < 1
Recruiting
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65
Engage in heavy alcohol use defined as drinking equal or greater than 14 standard drinks per week if male and equal or greater than 7 standard drinks per week if female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to post-treatment, up to 1.5-2 months.
Awards & highlights

Study Summary

This trial will explore if the drug suvorexant modifies brain and behavior targets of alcohol use disorder. Participants will complete tests and take the drug for 4 weeks before repeating the tests.

Who is the study for?
This trial is for adults aged 18-65 with moderate to severe alcohol use disorder (AUD), who drink heavily but are generally healthy. They must not be seeking AUD treatment, smoke little or no cigarettes, and agree to birth control if applicable. Exclusions include obesity, certain medication use, metal implants, claustrophobia, pregnancy, significant health conditions like liver disease or sleep apnea, and other mental health disorders.Check my eligibility
What is being tested?
The study tests whether Suvorexant (SUV), an orexin receptor antagonist that affects brain-behavior stress responses in AUD patients can change their drinking behavior. Participants will randomly receive SUV or a placebo and undergo stress tests with EMG and possibly fMRI before and after taking the drug daily for four weeks.See study design
What are the potential side effects?
Possible side effects of Suvorexant may include drowsiness, headaches, dizziness; it might also affect mood or sleep patterns. Side effects will be monitored through daily smartphone reports during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I drink 14 or more drinks weekly if male, or 7 or more if female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post-treatment, up to 1.5-2 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post-treatment, up to 1.5-2 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol behavior and daily use of suvorexant.
Startle reactivity to stress with an acute dose of suvorexant.
Startle reactivity to stress with daily use of suvorexant.
Secondary outcome measures
Brain change and daily use of suvorexant.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Suvorexant TreatmentExperimental Treatment1 Intervention
Individuals will take 10mg of suvorexant (Merck & Co Inc.) during the Acute Drug Challenge and daily for 28 days.
Group II: ControlPlacebo Group1 Intervention
Individuals will take a placebo pill during the Acute Drug Challenge and daily for 28 days.
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?

Ohio State UniversityLead Sponsor
823 Previous Clinical Trials
501,163 Total Patients Enrolled
2 Trials studying Alcoholism
274 Patients Enrolled for Alcoholism

Media Library

Suvorexant (Orexin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05656534 — Phase < 1
Alcoholism Research Study Groups: Control, Suvorexant Treatment
Alcoholism Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT05656534 — Phase < 1
Suvorexant (Orexin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05656534 — Phase < 1

Frequently Asked Questions

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

Is this experiment presently recruiting participants?

"According to clinicaltrials.gov, this research program is presently registering participants. It was initially released on November 29th 2022 and the parameters have since been amended as of December 11th 2022."

Answered by AI

Does this experiment accept participants who are older than forty years of age?

"This medical trial requires that participants are aged 18 to 65. In comparison, 285 trials accept minors and 830 studies enlist seniors as test subjects."

Answered by AI

What is the current capacity of participants for this medical experiment?

"Affirmative, the information located on clinicaltrials.gov indicates that this trial is actively seeking volunteers. This project was initially posted November 29th 2022 and has been recently updated December 11th of the same year. The study requires 80 individuals to be recruited from a single location."

Answered by AI

Who might qualify for participation in this clinical research study?

"This medical study is recruiting 80 participants, aged 18 to 65, with an active alcohol use disorder. Patients must also provide informed consent and pass a physical and medical assessment in order to be eligible for the trial. Furthermore, individuals need to meet DSM-5 criteria for moderate or severe AUD as well as engage in heavy drinking (>14 drinks/week if male; >7 drinks/week if female)."

Answered by AI
~24 spots leftby Oct 2024