Recruiting
Phase 2

Apremilast

Sponsor:

Yale University

Code:

NCT07029529

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Apremilast 60mg

Placebo

Study Details

Brief summary:

For this protocol, the investigators plan to collect data to evaluate apremilast (60mg/day) vs placebo in adults with Alcohol Use Disorders (AUD).

Conditions

Alcohol Use Disorder

Study ID

NCT07029529

Start date

May 12, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 21-65.
2. Able to read and write English.
3. Meets DSM-5 criteria for current (past 6 months) AUD.
4. 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.
5. 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).
6. Able to take oral medications and willing to adhere to medication regimen.
7. Provision of signed and dated informed consent form
8. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

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 study 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. Individuals who are currently in treatment for drinking or who have attempted to quit drinking within the past 3 months in order to exclude participants seeking treatment.
14. Individuals with a history of serious withdrawal, and individuals who have repeatedly undergone alcohol detoxification.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Apremilast 60mg/day

Apremilast 60mg/day. Administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Day 1 10mg AM; Day 2 10mg AM, 10mg PM; Day 3 10mg AM, 20mg PM; Day 4 20mg AM, 20mg PM; Day 5 20 mg AM, 30mg PM; Day 6 30mg AM, 30mg PM. Once at steady state, administration is orally twice daily at 8:00 AM (30mg) and 8:00 PM (30mg).

placebo comparator: Placebo

Administered orally twice daily at 8:00 AM and 8:00 PM.

Interventions

Apremilast 60mg

Apremilast 60mg/day

Placebo

Placebo

Primary outcome measure

  • Alcohol Consumption [ Time Frame: Lab Sessions (Days 10, 17 & 24) ]

Central Contacts and Locations

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

More Information

Sponsor

Yale University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-08.