Medication Development in Alcoholism: Apremilast Versus Placebo
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Intervention: Apremilast; Placebo
Intervention description: Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.; Identical placebo pills taken orally for 14 days
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment, Double Blind, Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary hypotheses under test are that alcohol dependent subjects treated with apremilast
      will report decreased craving for alcohol following alcohol exposure in the laboratory and
      report significantly less drinking under naturalistic conditions, than those treated with
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers, 18-65 years of age

          -  Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity
             (AUD-MS)

          -  In the month prior to screening, reports drinking ≥ 21 standard drinks per week if
             male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females)
             per week.

          -  Subjects will not be seeking treatment because the medication studies are not
             treatment trials, and to avoid exposing treatment-seekers to alcohol cues

          -  Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the
             human lab session

          -  Negative BAC and a CIWA score of < 9 at time of lab session to eliminate acute alcohol
             or withdrawal effects on dependent measures.

          -  In acceptable health in the judgment of the study physician, on the basis of
             interview, medical history, physical exam, EKG, routine urine and blood chemistry.

          -  Females with childbearing potential must have a negative pregnancy test on the
             screening, randomization, and lab session visits and agree to use effective birth
             control for the duration required by a given study.

          -  Able to provide informed consent and understand questionnaires and study procedure

          -  Willing to comply with the provisions of the protocol and take daily oral medication.

        Exclusion Criteria:

          -  Active suicidal ideation, as systematically assessed with the Columbia Suicide
             Severity Rating Scale.

          -  Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety
             disorders or substance use disorders other than alcohol or nicotine

          -  Has a urine drug screen (UDS) positive for substances of abuse other than alcohol.

          -  Significant medical disorders that will increase potential risk or interfere with
             study participation as determined by the study physician

          -  Known hypersensitivity to apremilast

          -  Treatment within the month prior to screening with (1) an investigational drug, (2)
             medications which may negatively interact with study medications, or (3) drugs that
             may influence study outcomes (e.g., disulfiram [Antabuse], naltrexone [ReVia],
             acamprosate [Campral], anticonvulsants, or antidepressants).

          -  Ongoing treatment with medications that may increase risk, including prescribed,
             over-the-counter, and herbal preparations, as determined by the study physician.

          -  Sexually active female subjects with childbearing potential who are pregnant, nursing,
             or refuse to use effective methods of birth control for the duration required by a
             specific protocol.

          -  No fixed domicile and/or no availability by home or mobile telephone

          -  History of hypersensitivity to the study drug or the ingredients.

          -  Failure to take double-blind medication as prescribed.