Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2024-06-07
2027-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Subjects will be treated daily with an oral placebo.
Alcohol
The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
Placebo
The effects of placebo will be determined.
Suvorexant Dose 1
Subjects will be treated daily with oral suvorexant (10 mg).
Alcohol
The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
Suvorexant
The effects of suvorexant dose 1 will be determined.
Suvorexant Dose 2
Subjects will be treated daily with oral suvorexant (20 mg).
Alcohol
The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
Suvorexant
The effects of suvorexant dose 2 will be determined.
Interventions
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Alcohol
The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
Placebo
The effects of placebo will be determined.
Suvorexant
The effects of suvorexant dose 1 will be determined.
Suvorexant
The effects of suvorexant dose 2 will be determined.
Eligibility Criteria
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Exclusion Criteria
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.
21 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
William Stoops
OTHER
Responsible Party
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William Stoops
Professor
Principal Investigators
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William W Stoops, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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William Walton Stoops
Role: primary
Other Identifiers
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88524
Identifier Type: -
Identifier Source: org_study_id