Suvorexant for Alcohol Use Disorder: Brain Mechanisms
Researchers are studying Suvorexant, a drug approved for sleep, to see how it affects the brain in people with Alcohol Use Disorder (AUD) and healthy volunteers. They want to understand if Suvorexant can change dopamine receptors (brain chemicals involved in addiction) and potentially help with AUD. This study will compare Suvorexant to a placebo (an inactive tablet) in adults aged 18-75. The main goal is to see how Suvorexant impacts dopamine receptors in people with AUD undergoing detoxification, compared to healthy individuals. They will also look at how Suvorexant affects sleep and alcohol cravings. The study aims to enroll 180 participants.
- Study design
- This is an interventional study comparing Suvorexant to a placebo. It plans to enroll 180 participants, including healthy volunteers and individuals with Alcohol Use Disorder.
- What's involved
- Participants with AUD will stay in a clinic for at least 10-28 days for alcohol detoxification and receive normal AUD treatment. They will also receive either Suvorexant or a placebo.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, examining the impact of suvorexant on dopamine receptors, will be measured at 3 years.
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NCT06484075
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
Recruiting
PHASE1Ages 18–75InterventionalBasic scienceNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Government-funded
~180 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:PlaceboSuvorexant
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls.
Measured over 3 years
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Nora D Volkow Adler, M.D. · PRINCIPAL_INVESTIGATOR · National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
All Participants
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
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 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.
Exclusion
All Participants
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. Urine pregnancy tests will be repeated on subsequent days of study (i.e., within 24 hours before study procedures). Females must not be currently breastfeeding.
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 bradycardia, and HIV+).
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 assessments that are validated for English; only some are available in Spanish. In addition, our fMRI paradigms require that the subject be able to speak, read and comprehend English.
AUD Participants
Current daily use of stimulant medications, modafinil, wellbutrin, naltrexone, antipsychotics, or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan).
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 months prior to enrollment.
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 and clinical exam.
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 until BrAC \<0.08. This is not expected to happen in most cases especially since participants will have been detoxifying for 1-5 days (possibly longer) and should no longer test positive for BrAC at this point. After initial screening under 14AA0181, subjects will be in the inpatient unit detoxifying.
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, AUD subjects may proceed with study day testing procedures even if saliva results for THC are positive. If any AUD participants test positive for saliva THC-COOH, we may include those results as a covariate in our statistical analyses.
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 subjects will have been in the inpatient unit detoxifying from alcohol and won't have access to drugs of misuse during this time. Positive results could be indicative of slow metabolizers of drugs and subject may stay enrolled and participate in the imaging scans.
Control Participants
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 that could impact brain function at the time of the study as determined by history and clinical exam.
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 medications; antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antihistamines (sedating); beta-blocker antihypertensives; antineoplastics; antiobesity; antipsychotics; anxiolytics (benzodiazepine or barbiturates); lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos); sedatives/hypnotics, systemic steroids. Note that nicotine and/or caffeine is not exclusionary.
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 rescheduled study days resulting from positive urine drug/breath alcohol screens. If urine drug screen is positive for THC-COOH, a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative. If the urine/saliva drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study.
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, procedures will be postponed until it becomes negative.
If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine they will be excluded.
What this trial measures
- To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls.3 years
We hypothesize that suvorexant compared to placebo will (1) increase striatal dopamine D2 receptors while decreasing the balance of D1 to D2 receptor signaling (D1R/D2R) and (2) improve sleep and reduce alcohol craving and dysphoria.