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Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Miricorilant
Placebo oral tablet
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder focused on measuring Alcohol-Related Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Miricorilant

Placebo

Arm Description

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

Six placebo tablets taken orally for two weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 6, 2020
Last Updated
January 31, 2023
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04466215
Brief Title
Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
Official Title
Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Alcohol-Related Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment, Double-Blind, Randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Miricorilant
Arm Type
Active Comparator
Arm Description
900 mg (6 x 150 mg) tablets daily taken orally for two weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Six placebo tablets taken orally for two weeks
Intervention Type
Drug
Intervention Name(s)
Miricorilant
Other Intervention Name(s)
CORT118335
Intervention Description
900 mg (6 x 150 mg) tablets taken orally once daily for two weeks
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Sugar pill
Intervention Description
Six placebo tablets taken orally once daily for two weeks
Primary Outcome Measure Information:
Title
Craving to Drink
Description
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.
Time Frame
1 hour on the last day of dosing (Day 14)
Secondary Outcome Measure Information:
Title
Drinking
Description
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.
Time Frame
11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

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