Healthy VolunteersPhase 1/2NCT06484075
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
A Phase 1/2 study testing Siemens 3T PRISMA MR Scanner, PET/CT Scanner and Suvorexant in people with Healthy Volunteers and Alcohol Use Disorder (AUD), run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Alcohol Use Disorder (AUD)
- What is being tested?
- Siemens 3T PRISMA MR Scanner, PET/CT Scanner and Suvorexant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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
Show all 15Show fewer
- To be eligible to participate in this study, an individual with AUD must meet all of the "All Participants" inclusion criteria (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 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.
Who cannot join
- -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.
Show all 36Show fewer
- 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 involving imaging scans (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
- 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, 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.
- Note that AUD subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs/alcohol on initial screening. The following guidelines will be followed for positive drug/alcohol screens on study procedure days involving imaging scans:
- -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 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.
- We minimized exclusion criteria pertaining to current medication use in the AUD group participants to make recruitment feasible and so the outcome can be better generalized to vulnerable AUD populations which have high rates of comorbid mental and physical illness requiring medication. Note however that although current daily use of naltrexone is an exclusion per above, once the imaging scans and study drug dosing are completed, standard of care treatment will be started a few days prior to discharge and this could include taking naltrexone daily. This will not be considered a violation or non-compliance or deviation from criteria listed above once the imaging studies are complete. Standard of care may start within 24 hours of last study drug medication dose or last brain imaging scan under the current protocol, whichever happens last. This treatment is initiated for a few days under the 14AA0181 Natural History protocol prior to discharge from the unit.
- -Control Participants
- A control individual who meets any of the criteria listed under "All Participants" exclusion criteria (listed above) or any of the following criteria will be excluded from participation in this study:
- 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.
- When developing this protocol to include healthy volunteers, we needed a population not taking medications that could impact our interpretation of dopamine level measurements, since we are hoping to get estimates of 'baseline' dopamine levels in this control population.
- Note that subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs/alcohol on initial screening. The following guidelines will be followed for positive drug/alcohol screens on study procedure days involving imaging scans in HV participants:
- 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. 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.
Read more
Objective:
To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.
Eligibility:
People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.
Design:
Participants with AUD will stay in the clinic for at least 10-28 days for alcohol detoxification. They will receive normal treatment for AUD.
Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.
Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay.
Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.
Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies.
Imaging scans and other tests will be repeated at the end of the study.
Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.
...
Read the detailed description
Study Description:
This protocol examines effects of a 10-28 day course of suvorexant treatment on brain dopamine receptors, brain reactivity to cues and symptomatology in individuals with alcohol use disorder (AUD) undergoing detoxification. 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.
Objectives:
Primary 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 objectives: To examine suvorexant's effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification.
Endpoints:
Primary Endpoint: Suvorexant's effects on brain dopamine receptors:
-Striatal dopamine D1 and D2 receptor availabilities and D1R/D2R ratios
Secondary Endpoints: Effects of suvorexant on:
- N3, REM, and total sleep duration (assessed with polysomnography)
- Self-reports of sleep quality
- Self-reports of alcohol craving and mood
Exploratory Endpoints:
- Brain structure, function, chemistry and cerebrospinal fluid (CSF) dynamics as assessed by MRI (task and resting fMRI, MRS, structural MRI, and diffusion tensor imaging or DTI)
- Cognitive Test Performance
- Conditions
- Healthy Volunteers, Alcohol Use Disorder (AUD)
- Being tested
- Siemens 3T PRISMA MR Scanner, PET/CT Scanner, Suvorexant, Placebo
- Keywords
- Suvorexant, Sleep, Dopamine D2R, Dopamine D1R, Alcohol Use Disorder (AUD), Alcohol Craving
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siemens 3T PRISMA MR ScannerDevice
MRI scans
PET/CT ScannerDevice
PET/CT scans
SuvorexantDrug
Drug approved for improving sleep
PlaceboDrug
The placebo will be a tablet, but only containing inert inactive ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Non treatment | No intervention | Healthy Volunteers will receive two PET scans and one MRI session without any treatment. |
| Placebo | Placebo comparator | AUD subjects randomized to receive placebo for up to 28 days during inpatient treatment. Receives: Device: Siemens 3T PRISMA MR Scanner; Device: PET/CT Scanner; Drug: Placebo |
| Suvorexant | Active comparator | AUD subjects randomized to receive Suvorexant (20 mg po) for up to 28 days during inpatient treatment. Receives: Device: Siemens 3T PRISMA MR Scanner; Device: PET/CT Scanner; Drug: Suvorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls.
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.
Measured: 3 years
Secondary outcomes (1)
To examine suvorexant's effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification.
We hypothesize that suvorexant compared to placebo will improve sleep and reduce alcohol craving and dysphoria.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start21 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nora D Volkow Adler, M.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484075
- Sponsor's protocol ID
- 10001561
- Other IDs
- 001561-AA
- Status last verified
- 14 Oct 2026
- First submitted
- 29 Jun 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data is analyzed by subject group and not on an individual basis.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
- ClinicalTrials.gov ID
- NCT06484075
- Acronym / sponsor ID
- 10001561
- Conditions
- Healthy Volunteers, Alcohol Use Disorder (AUD)
- Keywords
- Suvorexant, Sleep, Dopamine D2R, Dopamine D1R, Alcohol Use Disorder (AUD), Alcohol Craving
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.
Objective:
To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.
Eligibility:
People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.
Design:
Participants with AUD will stay in the clinic for at least 10-28 days for alcohol detoxification. They will receive normal treatment for AUD.
Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.
Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay.
Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.
Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies.
Imaging scans and other tests will be repeated at the end of the study.
Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.
...
Detailed description
Study Description:
This protocol examines effects of a 10-28 day course of suvorexant treatment on brain dopamine receptors, brain reactivity to cues and symptomatology in individuals with alcohol use disorder (AUD) undergoing detoxification. 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.
Objectives:
Primary 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 objectives: To examine suvorexant's effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification.
Endpoints:
Primary Endpoint: Suvorexant's effects on brain dopamine receptors:
-Striatal dopamine D1 and D2 receptor availabilities and D1R/D2R ratios
Secondary Endpoints: Effects of suvorexant on:
- N3, REM, and total sleep duration (assessed with polysomnography)
- Self-reports of sleep quality
- Self-reports of alcohol craving and mood
Exploratory Endpoints:
- Brain structure, function, chemistry and cerebrospinal fluid (CSF) dynamics as assessed by MRI (task and resting fMRI, MRS, structural MRI, and diffusion tensor imaging or DTI)
- Cognitive Test Performance
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non treatment | No intervention | –Healthy Volunteers will receive two PET scans and one MRI session without any treatment. |
| Placebo | Placebo comparator | Device: Siemens 3T PRISMA MR Scanner, Device: PET/CT Scanner, Drug: PlaceboAUD subjects randomized to receive placebo for up to 28 days during inpatient treatment. |
| Suvorexant | Active comparator | Device: Siemens 3T PRISMA MR Scanner, Device: PET/CT Scanner, Drug: SuvorexantAUD subjects randomized to receive Suvorexant (20 mg po) for up to 28 days during inpatient treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (36 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siemens 3T PRISMA MR ScannerMRI scans | Device | Placebo, Suvorexant |
| PET/CT ScannerPET/CT scans | Device | Placebo, Suvorexant |
| SuvorexantDrug approved for improving sleep | Drug | Suvorexant |
| PlaceboThe placebo will be a tablet, but only containing inert inactive ingredients. | Drug | Placebo |
Primary outcome
To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls.
Time frame: 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.
1 secondary outcome
To examine suvorexant's effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data is analyzed by subject group and not on an individual basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nora D Volkow Adler, M.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Siemens 3T PRISMA MR Scanner, PET/CT Scanner and Suvorexant in people with Healthy Volunteers and Alcohol Use Disorder (AUD), run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora D Volkow Adler, M.D. ((301) 443-6480, nvolkow@nida.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.