Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 15, 2022

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Miricorilant
    • 900 mg (6 x 150 mg) tablets daily taken orally for two weeks
  • Placebo Comparator: Placebo
    • Six placebo tablets taken orally for two weeks

Clinical Trial Outcome Measures

Primary Measures

  • Craving to Drink
    • Time Frame: 1 hour on the last day of dosing (Day 14)
    • 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.

Secondary Measures

  • Drinking
    • Time Frame: 11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Scripps Research Institute
  • Collaborator
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Barbara J. Mason, Ph.D., Principal Investigator, The Scripps Research Institute

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