Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
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|ClinicalTrials.gov Identifier: NCT04466215|
Recruitment Status : Completed
First Posted : July 10, 2020
Results First Posted : February 3, 2023
Last Update Posted : February 3, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Miricorilant Drug: Placebo oral tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment, Double-Blind, Randomized|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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 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
- 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.
- 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.
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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|
- 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
- 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.
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
|United States, California|
|The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Barbara J. Mason, Ph.D.||The Scripps Research Institute|
Documents provided by The Scripps Research Institute:
|Responsible Party:||The Scripps Research Institute|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|