Suvorexant and Alcohol

NCT06326684 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 88524R01AA030775
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Reinforcing Effects of Alcohol

  Number of Times Subjects Choose Alcohol (Maximum of 5 Choices) Over Money

  6 times over approximately 3 week inpatient admission.

Secondary Outcomes (12)

• Craving

  6 times over approximately 3 week inpatient admission.

• Mood

  6 times over approximately 3 week inpatient admission.

• Alcohol Response

  6 times over approximately 3 week inpatient admission.

• Heart rate

  Daily over approximately 3 week inpatient admission.

• Blood pressure

  Daily over approximately 3 week inpatient admission.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects will be treated daily with an oral placebo.

Drug: Alcohol; Drug: Placebo

Suvorexant Dose 1

EXPERIMENTAL

Subjects will be treated daily with oral suvorexant (10 mg).

Drug: Alcohol; Drug: Suvorexant

Suvorexant Dose 2

EXPERIMENTAL

Subjects will be treated daily with oral suvorexant (20 mg).

Drug: Alcohol; Drug: Suvorexant

Interventions

Suvorexant DRUG

The effects of suvorexant dose 1 will be determined.

Suvorexant Dose 1

Alcohol DRUG

The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.

Placebo; Suvorexant Dose 1; Suvorexant Dose 2

Placebo DRUG

The effects of placebo will be determined.

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Gender Eligibility Details: All gender identities are eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Stoops: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; suvorexant

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• William W Stoops, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William W Stoops, PhD

CONTACT

8592575388; william.stoops@uky.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)