Phase 2 Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For all participants:

• People aged 18 to 75 years old, of any gender
• People who are willing to follow all study procedures and be available for the full duration of the study
• People who are able to understand and are willing to sign a written consent form

For participants with alcohol use disorder (AUD) specifically:

• People who have received a diagnosis of moderate or severe alcohol use disorder (AUD) under standard diagnostic criteria (DSM-5)
• People who are actively seeking treatment for their AUD
• People with a history of heavy drinking for at least 5 years, where heavy drinking means 5 or more drinks per day on at least 5 days per month for men, or 4 or more drinks per day on at least 5 days per month for women
• People whose last alcohol use was within the 7 days before enrolling in a linked study (Natural History protocol 14AA0181)
• People who report having sleep problems, such as trouble falling or staying asleep, or who score above 4 on a standard sleep quality questionnaire
• People who are able to swallow tablets and are willing to take the study medication (suvorexant or a placebo) as directed
• People who are able to commit to an inpatient (hospital) stay of at least 28 days and up to 40 days
• People who agree to follow the lifestyle guidelines set out for the study

Who may not be able to join:

For all participants:

• People who have metal objects in their body that are not safe for MRI scans, who have a fear of enclosed spaces, or who have any other standard reason they cannot have an MRI
• People who are unable to lie flat on their back comfortably for up to 2 hours in an MRI scanner
• People who weigh more than 400 pounds, due to the weight limit of the PET scanner
• People whose previous radiation exposure from X-rays, PET scans, or other sources would, combined with this study, exceed the annual research limits set by the NIH
• People who are currently pregnant or breastfeeding; women of childbearing age or who are 55 or younger will need to have a negative urine pregnancy test before and during the study
• People who have had a serious head injury involving loss of consciousness for more than 60 minutes
• People with ongoing conditions such as schizophrenia or bipolar 1 disorder
• People with severe depression or a significant level of suicidal thinking, as measured by a standard assessment tool
• People with serious medical conditions that can permanently affect brain function, such as epilepsy (seizures), stroke, Alzheimer's disease, Parkinson's disease, significant brain injury, certain heart rhythm problems, or HIV
• People whose liver enzyme levels are more than 5 times the normal upper limit, which would indicate serious liver damage
• People who are not able to read, speak, and understand English (confirm with trial site)

For AUD participants specifically:

• People who are currently taking certain medications every day, including stimulant medications, modafinil, Wellbutrin, naltrexone, antipsychotics, or certain strong medications that affect how the body processes drugs (confirm the full list with the trial site)
• People who are currently misusing benzodiazepines, opioids, or stimulants, defined as misuse on 5 or more days per week for more than 1 year, with use within 7 days of admission
• People who currently have a severe substance use disorder for substances other than alcohol, cannabis, nicotine, or caffeine — unless that disorder has been in remission for at least 6 months
• People who have medical conditions that make the study medication (suvorexant) unsafe for them, such as narcolepsy, severe sleep apnea, severe chronic lung disease, or a condition called REM sleep behaviour disorder

For healthy volunteer (control) participants specifically:

• People who have a current psychiatric diagnosis that has required daily psychiatric medication in the past 2 months, where that medication could affect brain function at the time of the study
• People with a history of moderate or severe substance use disorder for any substance other than nicotine or caffeine
• People who have been regularly taking certain medications in the past 2 months, including stimulants, opioids, antidepressants, antipsychotics, sedatives, anti-seizure medications, and several other categories — the full list should be confirmed with the trial site

Important: Always verify eligibility with the trial site directly before applying.