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NCT Number: NCT06326684

Suvorexant and Alcohol

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507, United States

Location status: Recruiting

Location contact

William W Stoops, PhD

PRINCIPAL_INVESTIGATOR

William Walton Stoops

CONTACT

[email protected]

8592575388

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Reinforcing Effects of Alcohol

    Time frame: 6 times over approximately 3 week inpatient admission.

    Number of Times Subjects Choose Alcohol (Maximum of 5 Choices) Over Money

Secondary outcomes

  1. Craving

    Time frame: 6 times over approximately 3 week inpatient admission.

    Subjects will report their craving during 6 sessions while they are admitted to our inpatient unit. Measured using a 10 point craving questionnaire with higher scores meaning greater craving.

  2. Mood

    Time frame: 6 times over approximately 3 week inpatient admission.

    Subjects will complete the Profile of Mood States during 6 sessions while they are admitted to our inpatient unit. Scores range from 0 to 4 with higher scores indicating stronger mood.

  3. Alcohol Response

    Time frame: 6 times over approximately 3 week inpatient admission.

    Subjects will complete the Biphasic Alcohol Effects Scale during 6 sessions while they are admitted to our inpatient unit. Scores range from 0 to 10 with higher scores indicating greater responses.

  4. Heart rate

    Time frame: Daily over approximately 3 week inpatient admission.

    Beats per minute. Measured daily during inpatient admission.

  5. Blood pressure

    Time frame: Daily over approximately 3 week inpatient admission.

    mm Hg. Measured daily during inpatient admission.

  6. Breath Alcohol Level

    Time frame: Daily over approximately 3 week inpatient admission.

    Percent. Measured daily during inpatient admission.

  7. Temperature

    Time frame: Daily over approximately 3 week inpatient admission.

    Degrees Fahrenheit. Measured daily during inpatient admission.

  8. Side Effects

    Time frame: Daily over approximately 3 week inpatient admission.

    Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.

  9. Delay Discounting

    Time frame: 6 times over approximately 3 week inpatient admission.

    Subjects will complete the delay discounting task during 6 sessions while they are admitted to our inpatient unit. Responses will be used to calculate discounting slope (i.e., K).

  10. n-back Task

    Time frame: 6 times over approximately 3 week inpatient admission.

    Subjects will complete the n-back task during 6 sessions while they are admitted to our inpatient unit. Percentage of correct responses will be the outcome.

  11. Stop-Signal Task Inhibitory Failures

    Time frame: 6 times over approximately 3 week inpatient admission.

    Subjects will complete the stop-signal task during 6 sessions while they are admitted to our inpatient unit. Proportion of inhibitory failures will be the outcome variable.

  12. Sleep

    Time frame: Daily over approximately 3 week inpatient admission.

    Subjects will complete the St. Mary's Sleep Questionnaire daily while they are admitted to our inpatient unit. Total sleep time will be the outcome variable and will be recorded in minutes. Higher scores indicate more sleep. Total sleep time is measured by self-report; minimum score=0, maximum score=1440 per day.

Study contacts

Contact information is provided by the study sponsor or research team.

William W Stoops, PhD

CONTACT

[email protected]

8592575388

Sponsors and collaborators

Lead sponsor

William Stoops

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Influence of Orexin Antagonism on Motivation for Alcohol

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 22, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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