Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

Study Overview
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Brief Summary
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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.

Official Title
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Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Miricorilant
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment, Double-Blind, Randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Miricorilant<br>900 mg (6 x 150 mg) tablets daily taken orally for two weeks | Drug: Miricorilant<br>* 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks<br>* Other names: CORT118335;|
| Placebo Comparator: Placebo<br>Six placebo tablets taken orally for two weeks | Drug: Placebo oral tablet<br>* Six placebo tablets taken orally once daily for two weeks<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol-Related Disorders