Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

NCT04466215 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: NIAAAMAS006420U01AA025476
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Alcohol-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Craving to Drink

  Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.

  1 hour on the last day of dosing (Day 14)

Secondary Outcomes (1)

• Drinking

  11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)

Study Arms (2)

Miricorilant

ACTIVE COMPARATOR

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

Drug: Miricorilant

Placebo

PLACEBO COMPARATOR

Six placebo tablets taken orally for two weeks

Drug: Placebo oral tablet

Interventions

Miricorilant DRUG

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

Also known as: CORT118335

Miricorilant

Placebo oral tablet DRUG

Six placebo tablets taken orally once daily for two weeks

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol-Related Disorders

Interventions

CORT118335; Sugars

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Barbara J.. Mason, Ph.D.
• Organization: The Scripps Research Institute

mason@scripps.edu

(858) 784-7324

Study Officials

• Barbara J. Mason, Ph.D.

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, Double-Blind, Randomized

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: April 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: June 7, 2022
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)