Alcohol Use DisorderPhase 2NCT07214207
Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking
A Phase 2 study testing Suvorexant 10 mg in people with Alcohol Use Disorder, run by Ohio State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are: Is SUV effective for AUD? Does SUV dampen stress reactivity? Can the researchers develop a biomarker for SUV treatment response? Researchers will… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Suvorexant 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to Sep 2030
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally medically and neurologically healthy;
- Age 18 to 65 at the time of consent;
- Willing and able to give informed consent;
- Current DSM-5 diagnosis of moderate to severe alcohol use disorder;
- Engages in heavy alcohol use defined as drinking ≥14 standard drinks per week if male, and ≥7 standard drinks per week if female;
- Self-reported treatment-seeking for alcohol use disorder
Who cannot join
- Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or interfere with the study protocol, and/or be contraindicated for suvorexant including sleep disorders (e.g., narcolepsy; severe obstructive sleep apnea), hepatic impairment, compromised respiratory function, renal impairment, and endocrine disorders;
- Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
- Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder;
- Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women);
- Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants);
- Current antihistamines use or medication use that may increase risk including, prescribed, over-the-counter, and herbal preparations, as determined by the study physician;
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- Current use of strong or moderate inhibitors of CYP3A liver enzymes;
- Current use of strong CYP3A inducers;
- Current use of digoxin;
- Liver function tests more than 3 times the upper limit of normal or elevated bilirubin;
- Engages in night shift work;
- Smoke 10 or more cigarettes (or electronic equivalent) per day and are thus susceptible to acute nicotine withdrawal during lab visits;
- Obesity as defined by a body-mass index (BMI) equal or greater than 30, as calculated from weight and height self-report;
- Clinically significant alcohol withdrawal symptoms the day of the lab sessions, defined as a score >10 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar);
- Unwilling/unable to sign the informed consent document;
- Under 18 years old or over 65 years old at the time of enrollment;
- Have attempted suicide in the past 3 years and/or have current suicidal ideation determined as greater than moderate via the Columbia Suicide Severity Rating Scale (C-SSRS)
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
Ohio State University
Columbus, Ohio, 43210
Stephanie Gorka, PhD
About this study
The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are:
- Is SUV effective for AUD?
- Does SUV dampen stress reactivity?
- Can the researchers develop a biomarker for SUV treatment response?
Read more
Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD.
Participants will:
- Take 10mg capsules of SUV or a placebo orally each night before bedtime for 8-weeks.
- Visit the laboratory before (baseline), 4-weeks (mid-point), and 8-weeks (end-point) after taking SUV or placebo that include the psychophysiological stress paradigm (electromyography; EMG).
- Complete daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 8-week medication trial.
- Conditions
- Alcohol Use Disorder
- Being tested
- Suvorexant 10 mg, Placebo
- Keywords
- suvorexant, alcohol use disorder, electromyography
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suvorexant 10 mgDrug
Also called Belsomra
This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. Suvorexant (SUV) will be placed in opaque capsules with dextrose filler. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4 weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial.
PlaceboOther
This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. The placebo pill will be identical in appearance to suvorexant but will contain only dextrose. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Individuals will take a placebo pill daily for 8-weeks. Receives: Other: Placebo |
| Suvorexant | Experimental | Individuals will take 10mg of suvorexant (Merck \& Co Inc.) daily for 8-weeks. Receives: Drug: Suvorexant 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Heavy Drinking Days
Self-reported heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measured as proportion of heavy drinking days.
Measured: 8-week treatment period
Startle eyeblink potentiation
Startle eyeblink potentiation will be collected during the NPU threat task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.
Measured: Baseline; 4-weeks; 8-weeks
Alcohol Craving Via Ecological Momentary Assessment (EMA)
Participants will rate the intensity of their alcohol cravings using a Likert scale of 1 (lowest craving) -7 (highest craving).
Measured: 8-week treatment period
Secondary outcomes (5)
Drinks Per Day
Self-reported total number of alcoholic drinks per day of the trial.
Measured: 8-week treatment period
Proportion of Days Abstinent
Self-reported proportion of days that individuals were abstinent from alcohol use.
Measured: 8-week treatment period
Transdermal Alcohol Concentration (TAC)
Participants' TAC will provide an objective estimate of alcohol consumption each day.
Measured: 8-week treatment period
Phosphatidylethanol (PEth) levels
PEth will be measured from plasma samples at the mid-point and end-point. PEth is an objective biomarker of recent alcohol consumption.
Measured: 4-weeks; 8-weeks
Subjective Stress Levels via Ecological Momentary Assessment
Participants will rate their subjective stress levels using a Likert scale of 1 (least stress) - 5 (most stress).
Measured: 8-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start4 Dec 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Stephanie M Gorka, PhD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214207
- Sponsor's protocol ID
- STUDY20250713
- Other IDs
- R01AA032711
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from this project will be submitted to the NIAAA Data Archive (NDA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. The investigators will follow instructions as discussed in the NIAAA Data Archive Data Sharing Terms and Conditions.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking
- ClinicalTrials.gov ID
- NCT07214207
- Acronym / sponsor ID
- STUDY20250713
- Conditions
- Alcohol Use Disorder
- Keywords
- suvorexant, alcohol use disorder, electromyography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 9 Oct 2025 (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.
The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are:
- Is SUV effective for AUD?
- Does SUV dampen stress reactivity?
- Can the researchers develop a biomarker for SUV treatment response?
Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD.
Participants will:
- Take 10mg capsules of SUV or a placebo orally each night before bedtime for 8-weeks.
- Visit the laboratory before (baseline), 4-weeks (mid-point), and 8-weeks (end-point) after taking SUV or placebo that include the psychophysiological stress paradigm (electromyography; EMG).
- Complete daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 8-week medication trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboIndividuals will take a placebo pill daily for 8-weeks. |
| Suvorexant | Experimental | Drug: Suvorexant 10 mgIndividuals will take 10mg of suvorexant (Merck \& Co Inc.) daily for 8-weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Generally medically and neurologically healthy;
- Age 18 to 65 at the time of consent;
- Willing and able to give informed consent;
- Current DSM-5 diagnosis of moderate to severe alcohol use disorder;
- Engages in heavy alcohol use defined as drinking ≥14 standard drinks per week if male, and ≥7 standard drinks per week if female;
Key exclusion criteria (17 listed)
- Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or interfere with the study protocol, and/or be contraindicated for suvorexant including sleep disorders (e.g., narcolepsy; severe obstructive sleep apnea), hepatic impairment, compromised respiratory function, renal impairment, and endocrine disorders;
- Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
- Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder;
- Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women);
- Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants);
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 |
|---|---|---|
| Suvorexant 10 mgAlso: BelsomraThis study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. Suvorexant (SUV) will be placed in opaque capsules with dextrose filler. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4 weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial. | Drug | Suvorexant |
| PlaceboThis study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. The placebo pill will be identical in appearance to suvorexant but will contain only dextrose. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial. | Other | Control |
Primary outcome
Proportion of Heavy Drinking Days
Time frame: 8-week treatment period
Self-reported heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measured as proportion of heavy drinking days.
Startle eyeblink potentiation
Time frame: Baseline; 4-weeks; 8-weeks
Startle eyeblink potentiation will be collected during the NPU threat task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.
Alcohol Craving Via Ecological Momentary Assessment (EMA)
Time frame: 8-week treatment period
Participants will rate the intensity of their alcohol cravings using a Likert scale of 1 (lowest craving) -7 (highest craving).
5 secondary outcomes
Drinks Per Day
Time frame: 8-week treatment period
Proportion of Days Abstinent
Time frame: 8-week treatment period
Transdermal Alcohol Concentration (TAC)
Time frame: 8-week treatment period
Phosphatidylethanol (PEth) levels
Time frame: 4-weeks; 8-weeks
Subjective Stress Levels via Ecological Momentary Assessment
Time frame: 8-week treatment period
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data from this project will be submitted to the NIAAA Data Archive (NDA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. The investigators will follow instructions as discussed in the NIAAA Data Archive Data Sharing Terms and Conditions.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvorexant 10 mg in people with Alcohol Use Disorder, run by Ohio State University 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 6 inclusion and 17 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 21 Sep 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 phase mean?
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 Stephanie Gorka (614-366-1027, stephanie.gorka@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Heavy Drinking Days (time frame: 8-week treatment period). The study lists 3 primary outcomes in all. 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 21 Sep 2026.