An Early Phase 1 interventional study of Alcohol and Placebo in Alcohol Use Disorder, sponsored by William Stoops. Recruiting at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by William Stoops · Early Phase 1, Interventional, and Basic science
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 30 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →William Stoops is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion/Exclusion Criteria:
Subjects will be treated daily with an oral placebo.
Drug: Alcohol · Drug: Placebo
Subjects will be treated daily with oral suvorexant (10 mg).
Drug: Alcohol · Drug: Suvorexant
Subjects will be treated daily with oral suvorexant (20 mg).
Drug: Alcohol · Drug: Suvorexant
The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
The effects of placebo will be determined.
The effects of suvorexant dose 1 will be determined.
The effects of suvorexant dose 2 will be determined.
Reinforcing Effects of Alcohol
Number of Times Subjects Choose Alcohol (Maximum of 5 Choices) Over Money
Time frame: 6 times over approximately 3 week inpatient admission.
Craving
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.
Time frame: 6 times over approximately 3 week inpatient admission.
Mood
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.
Time frame: 6 times over approximately 3 week inpatient admission.
Alcohol Response
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.
Time frame: 6 times over approximately 3 week inpatient admission.
Heart rate
Beats per minute. Measured daily during inpatient admission.
Time frame: Daily over approximately 3 week inpatient admission.
Blood pressure
mm Hg. Measured daily during inpatient admission.
Time frame: Daily over approximately 3 week inpatient admission.
Breath Alcohol Level
Percent. Measured daily during inpatient admission.
Time frame: Daily over approximately 3 week inpatient admission.
Temperature
Degrees Fahrenheit. Measured daily during inpatient admission.
Time frame: Daily over approximately 3 week inpatient admission.
Side Effects
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.
Time frame: Daily over approximately 3 week inpatient admission.
Delay Discounting
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).
Time frame: 6 times over approximately 3 week inpatient admission.
n-back Task
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.
Time frame: 6 times over approximately 3 week inpatient admission.
Stop-Signal Task Inhibitory Failures
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.
Time frame: 6 times over approximately 3 week inpatient admission.
Sleep
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.
Time frame: Daily over approximately 3 week inpatient admission.
Plan to share: No
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William Stoops