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Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466215
Recruitment Status : Completed
First Posted : July 10, 2020
Results First Posted : February 3, 2023
Last Update Posted : February 3, 2023
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
The Scripps Research Institute

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Miricorilant Drug: Placebo oral tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment, Double-Blind, Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
Actual Study Start Date : April 15, 2021
Actual Primary Completion Date : April 15, 2022
Actual Study Completion Date : June 7, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Miricorilant
900 mg (6 x 150 mg) tablets daily taken orally for two weeks
Drug: Miricorilant
900 mg (6 x 150 mg) tablets taken orally once daily for two weeks
Other Name: CORT118335

Placebo Comparator: Placebo
Six placebo tablets taken orally for two weeks
Drug: Placebo oral tablet
Six placebo tablets taken orally once daily for two weeks
Other Name: Sugar pill




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466215


Locations
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United States, California
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Barbara J. Mason, Ph.D. The Scripps Research Institute
  Study Documents (Full-Text)

Documents provided by The Scripps Research Institute:
Study Protocol  [PDF] October 1, 2020
Statistical Analysis Plan  [PDF] September 28, 2020
Informed Consent Form  [PDF] February 3, 2022

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Responsible Party: The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT04466215    
Other Study ID Numbers: NIAAAMAS006420
U01AA025476 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2020    Key Record Dates
Results First Posted: February 3, 2023
Last Update Posted: February 3, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Scripps Research Institute:
Alcohol-Related Disorders
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders