Clinical trial NCT04466215: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: Alcohol-Related Disorders
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, Double-Blind, Randomized
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Craving to Drink
timeFrame: 1 hour on the last day of dosing (Day 14)
Secondary outcomes:
measure: Drinking
timeFrame: 11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J. Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: