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RecruitingAccepts healthy volunteersEarly Phase 1

Suvorexant and Alcohol

William Stoops · with National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NCT06326684

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
30
US sites recruiting
1
Study start
June 7, 2024
Record last updated
June 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.

Being studied: Alcohol; Placebo; Suvorexant; Suvorexant

Conditions: Alcohol Use Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion/Exclusion Criteria

  • Able to speak and read English.
  • Not seeking treatment at the time of the study.
  • Between the ages of 21 and 55 years.
  • Engaging in at least one binge drinking episode, per the NIAAA definition, in the last 30 days.
  • Fulfillment of moderate or severe DSM-5 diagnostic criteria for AUD based on computerized SCID results reviewed by a psychiatrist or psychologist.
  • ECG, read by cardiologist, within normal limits.
  • Body mass index of 19 - 35.
  • Birthing individuals using an effective form of birth control and not pregnant or breast feeding.
  • Judged by the medical staff to be psychiatrically and physically healthy (i.e., no current severe SUD or psychiatric diagnoses other than AUD or Tobacco Use Disorder; no current physical diagnoses that would interfere with study participation according to study physician judgment).
  • Not currently physiologically dependent on any substances.
  • Able to abstain from alcohol during admission (i.e., not physically dependent on alcohol and scores less than 8 on Clinical Institute Withdrawal Assessment for Alcohol [CIWA-Ar] at screening).
  • Not currently taking any prescribed medications for a chronic condition (other than birth control).
  • No indication of sleep apnea on the STOP-Bang questionnaire (score of 5 or greater).
  • No contraindications/allergies to suvorexant.

Recruiting US locations

  • Psychopharmacology of Addiction Laboratory

    Lexington, KY 40507

    Site contact: William Walton Stoops · 8592575388 · william.stoops@uky.edu

Study contacts (from the official record)

  • William W Stoops, PhD · 8592575388 · william.stoops@uky.edu
Suvorexant and Alcohol (NCT06326684) | Bored Studies