NCT04466215

Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

Completed Phase 2 Results posted Last updated 3 February 2023

What this trial tests

Phase 2 trial testing Miricorilant in Alcohol Use Disorder in 50 participants. Completed in 7 June 2022.

Timeline

15 April 2021

Primary endpoint
15 April 2022

7 June 2022

Quick facts

Lead sponsor	The Scripps Research Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	50
Start date	15 April 2021
Primary completion	15 April 2022
Estimated completion	7 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Miricorilant — full drug profile →
• Placebo oral tablet — full drug profile →

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

The Scripps Research Institute

Who can join

Adults 18 to 75, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Craving to Drink Primary · 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.

Group	Value	95% CI
CORT118335	31.1	23.8 – 38.5
Placebo	33.2	23.3 – 43.0

Drinking Secondary · 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.

Group	Value	95% CI
CORT118335	3.7	± .41
Placebo	3.7	± .29

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CORT118335

Serious: 0/25 (0%)

Deaths: 0/25

Placebo

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (5 terms — click to expand)

Reaction	System	CORT118335	Placebo
Nausea	Gastrointestinal disorders	—	—
Fatigue	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Feeling less euphoric	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT04466215 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.