Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

Alcohol Use Disorder Clinical Trial

Official title:

Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466215
• Other study ID #: NIAAAMAS006420
• Secondary ID: U01AA025476
• Status: Completed
• Phase: Phase 2
• Start date: April 15, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: January 2023
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 7, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Miricorilant
900 mg (6 x 150 mg) tablets taken orally once daily for two weeks
• Placebo oral tablet
Six placebo tablets taken orally once daily for two weeks

Locations

Country	Name	City	State
United States	The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Drinking	Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.; Treatment effects on drinking were assessed during the 11 days of ad libitum drinking and did not include the final three days of mandatory abstinence prior to cue reactivity session.	11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)