Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking

Who can take part

• 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 take part

• 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
• 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
• Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants)
• Liver function tests more than 3 times the upper limit of normal or elevated bilirubin
• Under 18 years old or over 65 years old at the time of enrollment
• Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women)
• Current use of strong CYP3A inducers
• Current use of digoxin
• 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
• 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)