Alcohol Use DisorderEarly Phase 1NCT06326684
Suvorexant and Alcohol
A Early Phase 1 study testing Alcohol and Suvorexant in people with Alcohol Use Disorder, run by William Stoops at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Alcohol and Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 15 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, 40507
William Walton Stoops, 8592575388, william.stoops@uky.edu
William W Stoops, PhD
About this study
Official title: Influence of Orexin Antagonism on Motivation for 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Alcohol, Placebo, Suvorexant
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
PlaceboDrug
The effects of placebo will be determined.
SuvorexantDrug
The effects of suvorexant dose 1 will be determined.
SuvorexantDrug
The effects of suvorexant dose 2 will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will be treated daily with an oral placebo. Receives: Drug: Alcohol; Drug: Placebo |
| Suvorexant Dose 1 | Experimental | Subjects will be treated daily with oral suvorexant (10 mg). Receives: Drug: Alcohol; Drug: Suvorexant |
| Suvorexant Dose 2 | Experimental | Subjects will be treated daily with oral suvorexant (20 mg). Receives: Drug: Alcohol; Drug: Suvorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Effects of Alcohol
Number of Times Subjects Choose Alcohol (Maximum of 5 Choices) Over Money
Measured: 6 times over approximately 3 week inpatient admission.
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 6 times over approximately 3 week inpatient admission.
Heart rate
Beats per minute. Measured daily during inpatient admission.
Measured: Daily over approximately 3 week inpatient admission.
Blood pressure
mm Hg. Measured daily during inpatient admission.
Measured: Daily over approximately 3 week inpatient admission.
Breath Alcohol Level
Percent. Measured daily during inpatient admission.
Measured: Daily over approximately 3 week inpatient admission.
Temperature
Degrees Fahrenheit. Measured daily during inpatient admission.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily over approximately 3 week inpatient admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start7 Jun 2024
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Stoops
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, William Stoops, University of Kentucky
- Investigators
- William W Stoops, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326684
- Sponsor's protocol ID
- 88524
- Other IDs
- R01AA030775
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Orexin Antagonism on Motivation for Alcohol
- ClinicalTrials.gov ID
- NCT06326684
- Acronym / sponsor ID
- 88524
- Conditions
- Alcohol Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- William StoopsUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Alcohol, Drug: PlaceboSubjects will be treated daily with an oral placebo. |
| Suvorexant Dose 1 | Experimental | Drug: Alcohol, Drug: SuvorexantSubjects will be treated daily with oral suvorexant (10 mg). |
| Suvorexant Dose 2 | Experimental | Drug: Alcohol, Drug: SuvorexantSubjects will be treated daily with oral suvorexant (20 mg). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholThe pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined. | Drug | Placebo, Suvorexant Dose 1, Suvorexant Dose 2 |
| PlaceboThe effects of placebo will be determined. | Drug | Placebo |
| SuvorexantThe effects of suvorexant dose 1 will be determined. | Drug | Suvorexant Dose 1 |
| SuvorexantThe effects of suvorexant dose 2 will be determined. | Drug | Suvorexant Dose 2 |
Primary outcome
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
12 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William W Stoops, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alcohol and Suvorexant in people with Alcohol Use Disorder, run by William Stoops at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William W Stoops, PhD (8592575388, william.stoops@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reinforcing Effects of Alcohol (time frame: 6 times over approximately 3 week inpatient admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.