NCT07214207 Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking
| NCT ID | NCT07214207 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ohio State University |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2025-12-04 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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; * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07214207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07214207 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07214207 currently recruiting?
Yes, NCT07214207 is actively recruiting participants. Contact the research team at stephanie.gorka@osumc.edu for enrollment information.
Where is the NCT07214207 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07214207 clinical trial?
NCT07214207 is sponsored by Ohio State University. The trial plans to enroll 250 participants.