Trial Outcomes & Findings for Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo (NCT NCT04466215)
NCT ID: NCT04466215
Last Updated: 2023-02-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
1 hour on the last day of dosing (Day 14)
Results posted on
2023-02-03
Participant Flow
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.
Twenty-seven subjects were excluded from study participation, twenty-five did not meet admission criteria and two declined to participate.
Participant milestones
| Measure |
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
|
Placebo
Six placebo tablets taken orally for two weeks
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
Baseline characteristics by cohort
| Measure |
CORT118335
n=25 Participants
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
|
Placebo
n=25 Participants
Six placebo tablets taken orally for two weeks
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.04 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
43.56 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 28.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
DSM-V symptom count
|
6.56 Symptom count
STANDARD_DEVIATION 1.9 • n=5 Participants
|
6.56 Symptom count
STANDARD_DEVIATION 1.5 • n=7 Participants
|
6.56 Symptom count
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hour on the last day of dosing (Day 14)Population: All subjects who completed cue exposure testing in the laboratory were included.
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.
Outcome measures
| Measure |
CORT118335
n=25 Participants
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
|
Placebo
n=24 Participants
Six placebo tablets taken orally for two weeks
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks
|
|---|---|---|
|
Craving to Drink
|
31.1 score on a scale
Interval 23.8 to 38.5
|
33.2 score on a scale
Interval 23.3 to 43.0
|
SECONDARY outcome
Timeframe: 11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)Population: All subjects with post baseline drinking data were included.
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.
Outcome measures
| Measure |
CORT118335
n=25 Participants
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
|
Placebo
n=25 Participants
Six placebo tablets taken orally for two weeks
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks
|
|---|---|---|
|
Drinking
|
3.7 Average drinks per day
Standard Error .41
|
3.7 Average drinks per day
Standard Error .29
|
Adverse Events
CORT118335
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CORT118335
n=25 participants at risk
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
|
Placebo
n=25 participants at risk
Six placebo tablets taken orally for two weeks
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
2/25 • 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.
|
0.00%
0/25 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • 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.
|
12.0%
3/25 • 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.
|
|
Nervous system disorders
Fatigue
|
12.0%
3/25 • 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.
|
0.00%
0/25 • 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.
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • 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.
|
8.0%
2/25 • 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.
|
|
Psychiatric disorders
Feeling less euphoric
|
8.0%
2/25 • 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.
|
0.00%
0/25 • 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.
|
Additional Information
Dr. Barbara J.. Mason, Ph.D.
The Scripps Research Institute
Phone: (858) 784-7324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place