Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

The Scripps Research Institute

Status and phase: Completed; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: Miricorilant; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04466215

U01AA025476

NIAAAMAS006420

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Miricorilant

Active Comparator group

Description:

900 mg (6 x 150 mg) tablets daily taken orally for two weeks

Treatment:

Drug: Miricorilant

Placebo

Placebo Comparator group

Description:

Six placebo tablets taken orally for two weeks

Treatment:

Drug: Placebo oral tablet