Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder

Exclusion Criteria14

• Subjects with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions, including HIV.
• Current DSM-5 substance use disorder (other than AUD or tobacco use disorder).
• A positive test result at intake appointment on urine drug screens conducted for illicit drugs.
• 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.
• 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).
• Suicidal, homicidal, or evidence of current (past 6 months) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders.
• Only one member per household can participate in the study.
• Specific exclusions for administration of apremilast not already specified include: known hypersensitivity to apremilast; cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin).
• Drugs that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants).
• 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.
• Subjects who have taken any investigational drug within 4 weeks immediately preceding admission to the study period.
• 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.
• 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.
• Individuals with a history of serious withdrawal, and individuals who have repeatedly undergone alcohol detoxification.