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| ID | Type | Description | Link |
|---|---|---|---|
| U01AA025476 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miricorilant | Active Comparator | 900 mg (6 x 150 mg) tablets daily taken orally for two weeks |
|
| Placebo | Placebo Comparator | Six placebo tablets taken orally for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miricorilant | Drug | 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour on the last day of dosing (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J. Mason, Ph.D. | The Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research | La Jolla | California | 92037 | United States |
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Twenty-seven subjects were excluded from study participation, twenty-five did not meet admission criteria and two declined to participate.
Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 04/15/2021-05/25/2022. Seventy-seven non-treatment seeking, paid volunteers signed informed consent, Fifty subjects were enrolled, and Fifty subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | CORT118335 | 900 mg (6 x 150 mg) tablets daily taken orally for two weeks CORT118335: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks |
| FG001 | Placebo | Six placebo tablets taken orally for two weeks Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CORT118335 | 900 mg (6 x 150 mg) tablets daily taken orally for two weeks CORT118335: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks |
| BG001 | Placebo | Six placebo tablets taken orally for two weeks Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects who completed cue exposure testing in the laboratory were included. | Posted | Mean | 95% Confidence Interval | score on a scale | 1 hour on the last day of dosing (Day 14) |
|
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).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CORT118335 | 900 mg (6 x 150 mg) tablets daily taken orally for two weeks CORT118335: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara J.. Mason, Ph.D. | The Scripps Research Institute | (858) 784-7324 | mason@scripps.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2020 | Jan 31, 2023 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2020 | Jan 31, 2023 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2022 | Jan 31, 2023 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000606526 | CORT118335 |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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Parallel Assignment, Double-Blind, Randomized
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| Placebo oral tablet | Drug | Six placebo tablets taken orally once daily for two weeks |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| DSM-V symptom count | Symptom count from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria for Alcohol Use Disorder (AUD) | Mean | Standard Deviation | Symptom count |
|
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|
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| Secondary | 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. | All subjects with post baseline drinking data were included. | Posted | Mean | Standard Error | Average drinks per day | 11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 9 |
| 25 |
| EG001 | Placebo | Six placebo tablets taken orally for two weeks Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks | 0 | 25 | 0 | 25 | 4 | 25 |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Feeling less euphoric | Psychiatric disorders | MedDRA | Systematic Assessment |
|
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