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New treatment option for Healthy Volunteers
Official title Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
ClinicalTrials.gov ID: NCT06484075
What this study is testing
What is Suvorexant?
Suvorexant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- All Participants To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ages 18-75 years old.
- Ability to understand and the willingness to sign a written informed consent document.
- AUD Participants To be eligible to participate in this study, an individual with AUD must meet all of the "All Participants" (listed above) and also...
You likely can't join if
- -All Participants An individual who meets any of the following criteria will be excluded from participation:
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard...
- Cannot lie comfortably flat on his/her back for up to 2 hours in the MRI scanner.
- Body weight \> 400 lbs. The PET scanner bed is tested to a weight limit of 400 lbs.
- Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual...
- Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a...
See the full eligibility criteria
Who can join
- All Participants To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ages 18-75 years old.
- Ability to understand and the willingness to sign a written informed consent document.
- AUD Participants To be eligible to participate in this study, an individual with AUD must meet all of the "All Participants" (listed above) and also meet the following criteria:
- DSM 5 diagnosis of moderate or severe AUD.
- Participants seeking treatment for their AUD.
- Current AUD with minimum 5-year lifetime history of heavy drinking (SAMSHA's criteria for heavy drinking: for men 5 or more drinks/day on at least 5 different days per month; and for women 4 or more drinks/day on at...
- Last alcohol use within the 7 days prior to enrollment in the Natural History protocol 14AA0181.
- Self-reported insomnia/sleep problems: PSQI score \> 4 and/or endorsing "problems falling asleep or staying asleep throughout the night".
- Ability to take oral medication and be willing to adhere to the suvorexant/placebo regimen.
- Agreement to commit to at least 28 days, and up to 40 days, inpatient stay (starting from Natural History protocol enrollment).
- Agreement to adhere to Lifestyle Considerations throughout study duration.
What rules you out
- -All Participants An individual who meets any of the following criteria will be excluded from participation:
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI.
- Cannot lie comfortably flat on his/her back for up to 2 hours in the MRI scanner.
- Body weight \> 400 lbs. The PET scanner bed is tested to a weight limit of 400 lbs.
- Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.
- Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a urine pregnancy test and it must be negative to continue participation...
- Severe head trauma with loss of consciousness \> 60 minutes.
- Chronic recurrent primary psychotic disorders like schizophrenia and bipolar 1 disorder.
- Montgomery-Asberg depression rating scale (MADRS) total score \> 35 or 'suicidal thoughts' item score \> 3, indicating severe depression or moderate suicidality, respectively.
- Major medical problems that can permanently impact brain function (e.g., seizures, psychosis, stroke, Alzheimer's disease, Parkinson's disease, traumatic brain injury, clinically significant arrhythmias except...
- Hepatic enzymes (ALT/GPT, AST/GOT, Total Bilirubin, Direct Bilirubin) that are \>5x the upper limit of normal, indicating severe hepatic impairment.
- Non-English speakers (must also be able to read and comprehend English).
- The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since it includes the administration of questionnaires, surveys and...
- AUD Participants An individual with AUD who meets any of the "All Participants" exclusion criteria (listed above) or any of the following criteria will be excluded from participation in this study:
- Current daily use of stimulant medications, modafinil, wellbutrin, naltrexone, antipsychotics, or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir...
- Current benzodiazepine, opioids, or stimulant misuse (must have misused 5+ days/week for \>1 year, and most recent use must have been within 7 days of inpatient admission).
- Current severe substance use disorders (other than alcohol, cannabis, nicotine or caffeine). If a subject had a severe SUD (other than alcohol, cannabis, nicotine or caffeine), they must be in remission for at least 6...
- Major medical problems that are contraindicated for the use of suvorexant (narcolepsy, severe obstructive sleep apnea or severe chronic obstructive pulmonary disease, REM behavioral disorder) as determined by history...
- If urine drug screen is positive for THC-COOH, a saliva drug screen will be performed. However, there are reports that THC can still be detected in saliva even eight days after cessation of drug use. Because of this...
- If any other urine results are positive, we may include those results as a covariate in our statistical analyses. It is important to note that the people will have been in the inpatient unit detoxifying from alcohol and...
- Current DSM-5 diagnosis of a psychiatric disorder that requires/required daily psychoactive medications (antidepressant, antipsychotics, stimulants, opioids, benzodiazepines or barbiturates) in the past two months and...
- History of moderate or severe substance use disorders (other than nicotine or caffeine).
- The following current chronically used (past 2 months) medications are exclusionary: stimulant or stimulant-like drugs and medications (cocaine, methamphetamine, amphetamine, methylphenidate, modafinil); opioid drugs or...
- If a subject's urine drug/breath alcohol (\>0.08%) screen test is positive on days involving imaging (MRI and/or PET) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3...
- If a participants urine drug screen test is positive for marijuana (urine drug screen positive for THC-COOH) on the day of the scan, we will then perform a saliva drug screen to verify if THC is present. If positive...
- If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine they will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.