Suvorexant and Alcohol

William Stoops

Status and phase: Enrolling; Early Phase 1

Conditions: Alcohol Use Disorder

Treatments: Drug: Suvorexant; Drug: Alcohol; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06326684

88524

R01AA030775 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will be treated daily with an oral placebo.

Treatment:

Drug: Placebo

Drug: Alcohol

Suvorexant Dose 1

Experimental group

Description:

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

Treatment:

Drug: Suvorexant

Drug: Alcohol

Drug: Suvorexant

Suvorexant Dose 2

Experimental group

Description:

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

Treatment:

Drug: Suvorexant

Drug: Alcohol

Drug: Suvorexant