Clinical trial 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?
An investigational oral medicine being studied to see how it affects brain chemicals in people with alcohol use disorder. is designed to block certain receptors in the brain that help regulate sleep and alertness.
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
- This study aims to learn how Suvorexant, a drug used for sleep problems, changes dopamine levels in the brain. Dopamine is a chemical that helps brain cells send signals.
- Who it's for
- The study is looking for adults aged 18 to 75 who are seeking treatment for alcohol use disorder, as well as healthy volunteers.
- What's involved
- Participants will take a daily pill, which may be the study drug or a fake pill. They will wear a wristwatch-like device to track movement and undergo brain scans, blood tests, and memory checks.
- Time commitment
- People with alcohol use disorder will stay in the clinic for 10 to 28 days, while healthy volunteers will visit for scans and wear the movement monitor for one week.
- 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
- 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.
- DSM 5 diagnosis of moderate or severe AUD.
- Participants seeking treatment for their AUD.
You likely can't join if
- 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...
- Severe head trauma with loss of consciousness \> 60 minutes.
See the full eligibility 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.
- 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
- 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.
- 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).
- 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.
- 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).
- If a subject's urine drug/breath alcohol (\>0.08%) screen test is positive on days involving imaging (MRI and/or PET), the procedures will be postponed and rescheduled.
- 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 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 is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.