Could an arthritis drug curb alcohol cravings?
NCT ID NCT06324435
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether a drug called apremilast can help people with Alcohol Use Disorder drink less alcohol. Ten adults will take the medicine and then have their drinking measured in a lab setting. The goal is to see if the drug reduces alcohol consumption, especially after stress.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 21-65. 4. Able to read and write English 5. Meets DSM-5 criteria for current (past 6 months) AUD 6. Drinking criteria: males - drinks \> 14 drinks per week and exceeds 4 drinks per day at least twice per week; females - drinks \> 7 drinks per week and exceeds 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period prior to baseline. 7. Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam) 8. Able to take oral medications and willing to adhere to a medication regimen. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Subjects with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions, including HIV 2. Current DSM-5 substance use disorder (other than AUD or tobacco use disorder) 3. A positive test result at intake appointment on urine drug screens conducted for illicit drugs. 4. Past 30-day use of psychoactive drugs may be included at the discretion of the study MD as long as the concurrent treatment does not compromise the study integrity by virtue of its type, duration, or intensity. 5. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD) 6. Suicidal, homicidal, or evidence of current (past 6 months) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders 7. Only one member per household can participate in the study 8. Specific exclusions for administration of apremilast not already specified include: known hypersensitivity to apremilast; cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin). 9. Drugs that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants). 10. Subjects likely to exhibit clinically significant alcohol withdrawal during the study. We will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments. 11. Subjects who have taken any investigational drug within 4 weeks immediately preceding admission to the treatment period. 12. Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application. 13. Those currently in treatment for alcohol use, individuals with a history of serious withdrawal, and individuals who have repeatedly undergone alcohol detoxification.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Yale University
New Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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