Trial Outcomes & Findings for INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers (NCT NCT02989662)
NCT ID: NCT02989662
Last Updated: 2025-05-30
Results Overview
Participants observed alcohol and neutral cues during functional MRI (fMRI) scans. Larger numbers indicate greater activation to alcohol versus non alcohol stimuli. Mean response Pre and Post medication (mifepristone (MIFE), placebo), is measured. The greater the number the greater the reactivity to alcohol-related cues.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Change from baseline (Day 1) to day 4 of MIFE dosing
Results posted on
2025-05-30
Participant Flow
Of the 65 participants who were consented for the study, 33 were determined to be ineligible during the assessment procedures. Among the 32 persons who were eligible, 16 were not randomized to study medication (8 participants were lost to follow-up and 8 participants withdrew from the study).
Participant milestones
| Measure |
Alcohol Use Disorder - Mifepristone
Participants diagnosed with alcohol use disorder who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
Mifepristone: Participants receive 6 doses.
|
Alcohol Use Disorder - Placebo
Participants diagnosed with alcohol use disorder who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
Placebo - Cap: Participants receive 6 doses
|
Healthy Control - Mifepristone
Healthy control participants who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Healthy Control - Placebo
Healthy control participants who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
6
|
3
|
|
Overall Study
COMPLETED
|
0
|
3
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Alcohol Use Disorder - Mifepristone
Participants diagnosed with alcohol use disorder who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
Mifepristone: Participants receive 6 doses.
|
Alcohol Use Disorder - Placebo
Participants diagnosed with alcohol use disorder who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
Placebo - Cap: Participants receive 6 doses
|
Healthy Control - Mifepristone
Healthy control participants who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Healthy Control - Placebo
Healthy control participants who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
Baseline characteristics by cohort
| Measure |
Alcohol Use Disorder - Mifepristone
n=4 Participants
Participants diagnosed with alcohol use disorder who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Alcohol Use Disorder - Placebo
n=3 Participants
Participants diagnosed with alcohol use disorder who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
Healthy Control - Mifepristone
n=6 Participants
Healthy control participants who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Healthy Control - Placebo
n=3 Participants
Healthy control participants who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
39.1 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change from baseline (Day 1) to day 4 of MIFE dosingPopulation: No data were collected for the AUD Mifepristone participants. AUD Mifepristone participants either dropped out or were withdrawn from the study prior to fMRI procedures. In addition, fMRI data were lost on one AUD-Placebo participant and one Healthy Control - Placebo participant due to head movement artifact.
Participants observed alcohol and neutral cues during functional MRI (fMRI) scans. Larger numbers indicate greater activation to alcohol versus non alcohol stimuli. Mean response Pre and Post medication (mifepristone (MIFE), placebo), is measured. The greater the number the greater the reactivity to alcohol-related cues.
Outcome measures
| Measure |
Alcohol Use Disorder - Mifepristone
Participants diagnosed with alcohol use disorder who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Alcohol Use Disorder - Placebo
n=2 Participants
Participants diagnosed with alcohol use disorder who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
Healthy Control - Mifepristone
n=6 Participants
Healthy control participants who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Healthy Control - Placebo
n=2 Participants
Healthy control participants who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
|---|---|---|---|---|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
Amygdala, centromedian - day 1
|
—
|
0.267390 BOLD response
Standard Error 0.128827
|
0.040281 BOLD response
Standard Error 0.074378
|
0.058670 BOLD response
Standard Error 0.128827
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
Amygdala, centromedian - day 4
|
—
|
-0.069048 BOLD response
Standard Error 0.142952
|
0.037178 BOLD response
Standard Error 0.082533
|
0.052388 BOLD response
Standard Error 0.142952
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
Amygdala, lateral - day 1
|
—
|
0.091174 BOLD response
Standard Error 0.190861
|
0.151864 BOLD response
Standard Error 0.110194
|
0.099169 BOLD response
Standard Error 0.190861
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
Amygdala, lateral - day 4
|
—
|
0.294417 BOLD response
Standard Error 0.115607
|
-0.021411 BOLD response
Standard Error 0.066746
|
0.126445 BOLD response
Standard Error 0.115607
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
medial prefrontal cortex - day 1
|
—
|
0.044635 BOLD response
Standard Error 0.287281
|
-0.323039 BOLD response
Standard Error 0.165862
|
0.031454 BOLD response
Standard Error 0.287281
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
medial prefrontal cortex - day 4
|
—
|
0.439822 BOLD response
Standard Error 0.226576
|
0.257514 BOLD response
Standard Error 0.130814
|
-0.514729 BOLD response
Standard Error 0.226576
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
nucleus accumbens - day 1
|
—
|
0.138441 BOLD response
Standard Error 0.147427
|
0.131360 BOLD response
Standard Error 0.085117
|
0.262425 BOLD response
Standard Error 0.147427
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
nucleus accumbens - day 4
|
—
|
0.285409 BOLD response
Standard Error 0.106153
|
0.138914 BOLD response
Standard Error 0.061287
|
-0.003538 BOLD response
Standard Error 0.106153
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
Amygdala, superficial - day 1
|
—
|
0.583073 BOLD response
Standard Error 0.269851
|
0.252555 BOLD response
Standard Error 0.155799
|
-0.111622 BOLD response
Standard Error 0.269851
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
Amygdala, superficial - day 4
|
—
|
0.149175 BOLD response
Standard Error 0.347008
|
0.172212 BOLD response
Standard Error 0.200345
|
0.118748 BOLD response
Standard Error 0.347008
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
ventral tegmental area - day 1
|
—
|
0.405165 BOLD response
Standard Error 0.227379
|
0.566876 BOLD response
Standard Error 0.131277
|
-0.019192 BOLD response
Standard Error 0.227379
|
|
Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli
ventral tegmental area - day 4
|
—
|
0.430387 BOLD response
Standard Error 0.176868
|
-0.150802 BOLD response
Standard Error 0.102115
|
0.104408 BOLD response
Standard Error 0.176868
|
SECONDARY outcome
Timeframe: single session on study day 5Population: This measure was designed to only be collected among the participants with alcohol use disorder (AUD). None of the AUD participants randomized to mifepristone completed the study. No data were collected for AUD-Mifepristone participants as they either dropped out or were withdrawn from the study prior to completing this procedure.
Participants made alcohol motivated responses with a computer mouse to earn either alcohol drinks or money. Each mouse click equaled one response. Mean of all responses made are reported.
Outcome measures
| Measure |
Alcohol Use Disorder - Mifepristone
Participants diagnosed with alcohol use disorder who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Alcohol Use Disorder - Placebo
n=3 Participants
Participants diagnosed with alcohol use disorder who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
Healthy Control - Mifepristone
Healthy control participants who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Healthy Control - Placebo
Healthy control participants who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
|---|---|---|---|---|
|
Mean of Alcohol Motivated Responses Made
|
—
|
9517 responses made
Standard Deviation 1497.6
|
—
|
—
|
SECONDARY outcome
Timeframe: single session on study day 5Population: This measure was designed to only be collected among the participants with alcohol use disorder (AUD). None of the AUD participants randomized to mifepristone completed the study. No data were collected for participants in the AUD-Mifepristone group. Participants either dropped out or were withdrawn from the study before completing this procedure.
Participants can earn up to 10 drinks during a 1-hr session. Each drink was the equivalent of 0.5 standard drink.
Outcome measures
| Measure |
Alcohol Use Disorder - Mifepristone
Participants diagnosed with alcohol use disorder who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Alcohol Use Disorder - Placebo
n=3 Participants
Participants diagnosed with alcohol use disorder who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
Healthy Control - Mifepristone
Healthy control participants who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Healthy Control - Placebo
Healthy control participants who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
|---|---|---|---|---|
|
Alcohol Motivated Responding - Number of Drinks Earned
|
—
|
7 drinks earned
Standard Deviation 3
|
—
|
—
|
Adverse Events
Alcohol Use Disorder - Mifepristone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol Use Disorder - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Control - Mifepristone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Health Control - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alcohol Use Disorder - Mifepristone
n=4 participants at risk
Participants diagnosed with alcohol use disorder who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Alcohol Use Disorder - Placebo
n=3 participants at risk
Participants diagnosed with alcohol use disorder who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
Healthy Control - Mifepristone
n=6 participants at risk
Healthy control participants who were randomized to receive mifepristone. Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
|
Health Control - Placebo
n=3 participants at risk
Healthy control participants who were randomized to receive placebo. This is an inactive compound which appears physically identical to active medication.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to 6 weeks post followup
|
0.00%
0/3 • Up to 6 weeks post followup
|
33.3%
2/6 • Number of events 2 • Up to 6 weeks post followup
|
0.00%
0/3 • Up to 6 weeks post followup
|
Additional Information
Mary E McCaul, Ph.D.
Johns Hopkins University School of Medicine
Phone: 4437225728
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place