Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Intervention: Miricorilant; Placebo oral tablet
Intervention description: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks; Six placebo tablets taken orally once daily for two weeks
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: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Alcohol-Related Disorders

Summary:

      The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or
      greater severity treated with CORT118335 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, 18-75 years of age.

          -  Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity
             (AUD-MS).

          -  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.

          -  In acceptable health in the judgment of the study physician, based on interview,
             medical history, physical exam, ECG, routine urine and blood chemistry.

          -  Subjects with a history of depression, who have been on a stable dose of
             anti-depressant medication for at least 3 months, and do not meet current DSM-5
             criteria for depression or anxiety.

          -  All subjects must agree to use double barrier birth control for the study duration and
             one month thereafter i.e., males must use condoms and females must use spermicide
             and/or a non hormonal barrier method, and their opposite sex partner must likewise use
             an effective non hormonal form of contraception.

          -  Able to provide informed consent and understand questionnaires and study procedures in
             English.

          -  Willing to comply with the provisions of the protocol and take daily oral medication

        Exclusion Criteria:

          -  Medical conditions that could be aggravated by glucocorticoid and/or mineralocorticoid
             antagonism.

          -  Clinically significant findings on physical exam, ECG, urine or blood tests that may
             increase risk.

          -  CYP2C19 inhibitors

          -  Substrates metabolized primarily by CYP3A, CYP2C9, and CYP2C8 with narrow therapeutic
             index

          -  BCRP and UGT1A1 substrates

          -  Meets DSM-5 criteria for a current major psychiatric disorder, including mood, anxiety
             or substance use disorders, other than alcohol, nicotine, or mild cannabis use
             disorders.

          -  Pregnant or lactating.

          -  Treatment within the month prior to screening with (1) an investigational drug, (2)
             drugs which may negatively interact with study medications, or (3) drugs that may
             influence study outcomes (e.g., disulfiram [Antabuse], naltrexone [ReVia], acamprosate
             [Campral], or anticonvulsants.

          -  Chronic systemic steroid use

          -  Using drugs that are strong inhibitors and inducers of CYP2C9.

          -  No fixed domicile and/or no availability by home or mobile telephone.