Suvorexant and Alcohol

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
William Stoops
Study ID
NCT06326684
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Alcohol — DRUG
    The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
  • Placebo — DRUG
    The effects of placebo will be determined.
  • Suvorexant — DRUG
    The effects of suvorexant dose 1 will be determined.
  • Suvorexant — DRUG
    The effects of suvorexant dose 2 will be determined.

Study Details

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.

Key Dates

Start date
Jun 7, 2024
Status verified
Jun 2026
Primary completion
Mar 15, 2027
Completion
Mar 15, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Psychopharmacology of Addiction LaboratoryLexingtonKentucky40507
William Walton Stoops
[email protected]
8592575388
William W Stoops, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, KY

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Psychopharmacology of Addiction Laboratory· Lexington, KY

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