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Recruiting NCT06326684

Suvorexant and Alcohol

Early Phase I Interventional Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alcohol, Placebo, Suvorexant, Suvorexant.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder. Basic parameters: 21 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Influence of Orexin Antagonism on Motivation for Alcohol

Overview

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.

Interventions

  • 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.
  • Drug Suvorexant
    The effects of suvorexant dose 1 will be determined.
  • Drug Suvorexant
    The effects of suvorexant dose 2 will be determined.

Primary outcome measures

  • Reinforcing Effects of Alcohol [Time frame: 6 times over approximately 3 week inpatient admission.]
Secondary outcome measures (12)
  • Craving [Time frame: 6 times over approximately 3 week inpatient admission.]
  • Mood [Time frame: 6 times over approximately 3 week inpatient admission.]
  • Alcohol Response [Time frame: 6 times over approximately 3 week inpatient admission.]
  • Heart rate [Time frame: Daily over approximately 3 week inpatient admission.]
  • Blood pressure [Time frame: Daily over approximately 3 week inpatient admission.]
  • Breath Alcohol Level [Time frame: Daily over approximately 3 week inpatient admission.]
  • Temperature [Time frame: Daily over approximately 3 week inpatient admission.]
  • Side Effects [Time frame: Daily over approximately 3 week inpatient admission.]
  • Delay Discounting [Time frame: 6 times over approximately 3 week inpatient admission.]
  • n-back Task [Time frame: 6 times over approximately 3 week inpatient admission.]
  • Stop-Signal Task Inhibitory Failures [Time frame: 6 times over approximately 3 week inpatient admission.]
  • Sleep [Time frame: Daily over approximately 3 week inpatient admission.]

Eligibility criteria

Inclusion/Exclusion Criteria:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Psychopharmacology of Addiction Laboratory — Lexington

Identifiers

NCT: NCT06326684 · 88524 · R01AA030775

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗