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Orexin Receptor Antagonist

Suvorexant for Alcoholism

Phase 1 & 2

Recruiting

Led By Peter G Manza, Ph.D.

Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be male or female, ages 18-75 years old

Be older than 18 years old

Must not have

Body weight > 400 lbs

Severe head trauma with loss of consciousness > 60 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Summary

"This trial will investigate how the drug Suvorexant affects dopamine receptors in people with alcohol use disorder (AUD) and in healthy individuals. Participants with AUD will undergo alcohol detoxification in the clinic

Who is the study for?

This trial is for individuals aged 18 to 75 who are seeking treatment for Alcohol Use Disorder (AUD) and healthy volunteers. Participants with AUD will undergo detoxification and receive standard treatments, while healthy subjects will be monitored without the need for detox.

What is being tested?

The study tests Suvorexant's effects on dopamine receptors in the brain among those with AUD and healthy people. It involves taking Suvorexant or a placebo daily, movement tracking, blood tests, brain imaging scans (PET and MRI), cognitive assessments, and sleep studies.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of Suvorexant may include drowsiness, headache, dizziness, dry mouth; less commonly it can cause abnormal dreams or sleep behaviors.

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 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My body weight is over 400 lbs.

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I have had a severe head injury with unconsciousness for over an hour.

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I can't lie flat on my back for 2 hours.

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I am not on any long-term medications that would exclude me from the trial.

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I have no major medical issues affecting my brain function.

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I use certain medications every day.

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I do not have major health issues that would prevent me from taking suvorexant.

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I am on daily medication for a mental health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls.

Secondary study objectives

To examine suvorexant s effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification.