Trial Outcomes & Findings for Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists (NCT NCT01548417)

NCT ID: NCT01548417

Last Updated: 2016-06-24

Results Overview

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: 56 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2016-06-24

Participant Flow

Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 03/16/2012-03/14/2014. One Hundred twenty nine non-treatment seeking, paid volunteers signed informed consent, Fifty six subjects were enrolled, and Fifty four subjects completed the study.

Sixty six subjects were excluded from study participation due to exclusionary criteria, 2 subjects did not return after Visit 1, 4 subjects withdrew consent (2 for time constraints following Visit 1, 1 due to social motivations, 1 due to moving out of state), and 1 subject left the lab during Visit 1 when asked to provide a urine sample.

Participant milestones

Measure	Korlym (Mifepristone) Korlym (mifepristone): 600 mg/day, oral pill, 7 days	Sugar Pill Sugar Pill: placebo, oral pill, 7 days
Overall Study STARTED	28	28
Overall Study COMPLETED	28	26
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Korlym (Mifepristone) Korlym (mifepristone): 600 mg/day, oral pill, 7 days	Sugar Pill Sugar Pill: placebo, oral pill, 7 days
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

Baseline characteristics by cohort

Measure	Korlym (Mifepristone) n=28 Participants Korlym (mifepristone): 600 mg/day, oral pill, 7 days	Placebo n=28 Participants Sugar Pill: placebo, oral pill, 7 days	Total n=56 Participants Total of all reporting groups
Age, Continuous	41.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	36.9 years STANDARD_DEVIATION 11.2 • n=7 Participants	39.1 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 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
DSM-V symptom count	6.2 number of symptoms STANDARD_DEVIATION 2.3 • n=5 Participants	6.9 number of symptoms STANDARD_DEVIATION 2.1 • n=7 Participants	6.5 number of symptoms STANDARD_DEVIATION 2.2 • n=5 Participants
Years of heavy drinking	15.0 years STANDARD_DEVIATION 11 • n=5 Participants	14.0 years STANDARD_DEVIATION 8.9 • n=7 Participants	14.5 years STANDARD_DEVIATION 9.9 • n=5 Participants
DSM-IV symptom count	4.7 number of symptoms STANDARD_DEVIATION 1.5 • n=5 Participants	5.1 number of symptoms STANDARD_DEVIATION 1.5 • n=7 Participants	4.8 number of symptoms STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: 1 participant who completed the study had missing VAS scores.

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	Korlym (Mifepristone) n=27 Participants Korlym (mifepristone): 600 mg/day, oral pill, 7 days	Sugar Pill n=26 Participants Sugar Pill: placebo, oral pill, 7 days
Craving to Drink	36.5 units on a scale Standard Error 1.5	42.9 units on a scale Standard Error 1.5

SECONDARY outcome

Timeframe: 2 weeks

Population: Three randomized subjects who met exclusionary criteria were not included in the regression analysis for drinking: two subjects were excluded for unreliable reporting and one subject was excluded for being treatment seeking.

Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70.

Outcome measures

Measure	Korlym (Mifepristone) n=26 Participants Korlym (mifepristone): 600 mg/day, oral pill, 7 days	Sugar Pill n=25 Participants Sugar Pill: placebo, oral pill, 7 days
Drinking	27.661 alcoholic drinks per week Standard Error 3.176	38.175 alcoholic drinks per week Standard Error 3.239

Adverse Events

Korlym (Mifepristone)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Korlym (Mifepristone) n=28 participants at risk Korlym (mifepristone): 600 mg/day, oral pill, 7 days	Sugar Pill n=26 participants at risk Sugar Pill: placebo, oral pill, 7 days
Respiratory, thoracic and mediastinal disorders Cold Symptoms	10.7% 3/28 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.	11.5% 3/26 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.
Nervous system disorders Dizzy/Foggy	10.7% 3/28 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.	3.8% 1/26 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.
Skin and subcutaneous tissue disorders Abrasions/Bruises	7.1% 2/28 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.	3.8% 1/26 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.
Musculoskeletal and connective tissue disorders Muscle Pain	10.7% 3/28 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.	3.8% 1/26 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.
General disorders Fatigue	10.7% 3/28 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.	3.8% 1/26 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.
Gastrointestinal disorders Nausea/Gastrointestinal upset	10.7% 3/28 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.	3.8% 1/26 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.
General disorders Headache	10.7% 3/28 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.	7.7% 2/26 • Adverse event data was collected at all five study visits, an average duration of 6 weeks. Adverse events, both serious and other, were documented at all five study visits by the Medical Assistant on the adverse events case report form.

Additional Information

Barbara J. Mason, Ph.D.

The Scripps Research Institute

Phone: 858-784-7328

Email: mason@scripps.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place