- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04466215
Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
January 31, 2023 updated by: The Scripps Research Institute
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Miricorilant
900 mg (6 x 150 mg) tablets daily taken orally for two weeks
|
900 mg (6 x 150 mg) tablets taken orally once daily for two weeks
Other Names:
|
Placebo Comparator: Placebo
Six placebo tablets taken orally for two weeks
|
Six placebo tablets taken orally once daily for two weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 hour on the last day of dosing (Day 14)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2021
Primary Completion (Actual)
April 15, 2022
Study Completion (Actual)
June 7, 2022
Study Registration Dates
First Submitted
July 6, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
February 3, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAAMAS006420
- U01AA025476 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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