Recruiting
Early Phase 1

Suvorexant & Alcohol

Sponsor:

William Stoops

Code:

NCT06326684

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Alcohol

Placebo

Suvorexant

Suvorexant

Study Details

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

Study ID

NCT06326684

Start date

Jun 7, 2024

Status verified date

Jun, 2026

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Inclusion/Exclusion Criteria:

1. Able to speak and read English.
2. Not seeking treatment at the time of the study.
3. Between the ages of 21 and 55 years.
4. Engaging in at least one binge drinking episode, per the NIAAA definition, in the last 30 days.
5. Fulfillment of moderate or severe DSM-5 diagnostic criteria for AUD based on computerized SCID results reviewed by a psychiatrist or psychologist.
6. ECG, read by cardiologist, within normal limits.
7. Body mass index of 19 - 35.
8. Birthing individuals using an effective form of birth control and not pregnant or breast feeding.
9. 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).
10. Not currently physiologically dependent on any substances.
11. 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).
12. Not currently taking any prescribed medications for a chronic condition (other than birth control).
13. No indication of sleep apnea on the STOP-Bang questionnaire (score of 5 or greater).
14. No contraindications/allergies to suvorexant.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Subjects will be treated daily with an oral placebo.

experimental: Suvorexant Dose 1

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

experimental: Suvorexant Dose 2

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

Interventions

Alcohol

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

Placebo

The effects of placebo will be determined.

Suvorexant

The effects of suvorexant dose 1 will be determined.

Suvorexant

The effects of suvorexant dose 2 will be determined.

Primary outcome measure

  • Reinforcing Effects of Alcohol [ Time Frame: 6 times over approximately 3 week inpatient admission. ]

Central Contacts and Locations

Central contacts

Locations

Psychopharmacology of Addiction Laboratory

Recruiting

Lexington, Kentucky, United States, 40507

Contacts

Principal Investigator:

William W Stoops, PhD

More Information

Sponsor

William Stoops

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Stoops on 2026-06-08.