Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

NCT ID: NCT04466215

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2022-06-07

Brief 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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Miricorilant

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

Group Type: ACTIVE_COMPARATOR

Miricorilant

Intervention Type: DRUG

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

Placebo

Six placebo tablets taken orally for two weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Six placebo tablets taken orally once daily for two weeks

Interventions

Miricorilant

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

Intervention Type: DRUG

Placebo oral tablet

Six placebo tablets taken orally once daily for two weeks

Intervention Type: DRUG

Other Intervention Names

CORT118335; Sugar pill

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

The Scripps Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara J. Mason, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Scripps Research Institute

Locations

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

La Jolla, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01AA025476

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAMAS006420

Identifier Type: -

Identifier Source: org_study_id