Suvorexant and Alcohol

Purpose

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.

Condition

  • Alcohol Use Disorder

Eligibility

Eligible Ages
Between 21 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 DisorderĶ¾
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

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Subjects will be treated daily with an oral placebo.
  • Drug: Alcohol
    The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
  • Drug: Placebo
    The effects of placebo will be determined.
Experimental
Suvorexant Dose 1 		Subjects will be treated daily with oral suvorexant (10 mg).
  • Drug: Alcohol
    The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
  • Drug: Suvorexant
    The effects of suvorexant dose 1 will be determined.
Experimental
Suvorexant Dose 2 		Subjects will be treated daily with oral suvorexant (20 mg).
  • Drug: Alcohol
    The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
  • Drug: Suvorexant
    The effects of suvorexant dose 2 will be determined.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Psychopharmacology of Addiction Laboratory
Lexington, Kentucky 40507
Contact:
William Walton Stoops
8592575388
william.stoops@uky.edu

More Details

NCT ID
NCT06326684
Status
Recruiting
Sponsor
University of Kentucky

Study Contact

William W Stoops, PhD
8592575388
william.stoops@uky.edu