Apremilast for Alcohol Use Disorder Treatment in Women and Men

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 theduration 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 dayat least twice per week; females - drinks > 7 drinks per week and exceeds 3 drinksper day at least twice per week. They must meet drinking criteria during aconsecutive 30-day period prior to baseline.

7. Laboratory sessions will be scheduled such that subjects will not have majorresponsibilities on the following day which might limit drinking during theself-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 orhallucinations, 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 forillicit drugs.

4. Past 30-day use of psychoactive drugs may be included at the discretion of the studyMD as long as the concurrent treatment does not compromise the study integrity byvirtue of its type, duration, or intensity.

5. Women who are pregnant or nursing, or fail to use one of the following methods ofbirth control unless she or her partner is surgically sterile or she ispostmenopausal (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 asschizophrenia, 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 thestudy. 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 onthe Clinical Institute Withdrawal Assessment scale at intake appointments.

11. Subjects who have taken any investigational drug within 4 weeks immediatelypreceding admission to the treatment period.

12. Participation within the past 8 weeks in other studies that involve additive bloodsampling and/or interventional measures that would be considered excessive incombination with the current application.

13. Those currently in treatment for alcohol use, individuals with a history of seriouswithdrawal, and individuals who have repeatedly undergone alcohol detoxification.