Trial Outcomes & Findings for Glutamatergic Modulation of Disordered Alcohol Use (NCT NCT02539511)

NCT ID: NCT02539511

Last Updated: 2020-02-11

Results Overview

Percentage of participants demonstrating alcohol abstinence in the control (midazolam) group versus the active (ketamine) group

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 50 participants
• Primary outcome timeframe: 21 days post-infusion
• Results posted on: 2020-02-11

Participant Flow

50 participants were enrolled in the study and from those, 40 were randomized.

Participant milestones

Measure	Control Group: Midazolam+MET 50-minute intravenous infusion of the active control midazolam (0.025 mg/kg), administered during the second week of a five week regimen of motivational enhancement therapy.	Active Group: Ketamine+MET 50-minute intravenous infusion of ketamine (0.71 mg/kg) administered during the second week of a five week regimen of motivational enhancement therapy.
Overall Study STARTED	23	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	6	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glutamatergic Modulation of Disordered Alcohol Use

Baseline characteristics by cohort

Measure	Control Group: Midazolam+MET n=23 Participants 50-minute intravenous infusion of the active control midazolam (0.025 mg/kg), administered during the second week of a five week regimen of motivational enhancement therapy.	Active Group: Ketamine+MET n=17 Participants 50-minute intravenous infusion of ketamine (0.71 mg/kg) administered during the second week of a five week regimen of motivational enhancement therapy.	Total n=40 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 8.3 • n=5 Participants	50.4 years STANDARD_DEVIATION 11.3 • n=7 Participants	53 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	13 Participants n=7 Participants	33 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
Region of Enrollment United States	23 participants n=5 Participants	17 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days post-infusion

Population: Medically healthy, treatment-seeking adults without psychiatric comorbidity and who met DSM-IV criteria for alcohol dependence and minimum use criteria.

Percentage of participants demonstrating alcohol abstinence in the control (midazolam) group versus the active (ketamine) group

Outcome measures

Measure	Control Group: Midazolam+MET n=23 Participants 50-minute intravenous infusion of the active control midazolam (0.025 mg/kg), administered during the second week of a five week regimen of motivational enhancement therapy.	Active Group: Ketamine+MET n=17 Participants 50-minute intravenous infusion of ketamine (0.71 mg/kg) administered during the second week of a five week regimen of motivational enhancement therapy.
Percentage of Participants Demonstrating Alcohol Abstinence in the Control (Midazolam) Group Versus the Active (Ketamine) Group	68.6 percentage of participants	98.6 percentage of participants

Adverse Events

Control Group: Midazolam+MET

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Active Group: Ketamine+MET

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Group: Midazolam+MET n=23 participants at risk 50-minute intravenous infusion of the active control midazolam (0.025 mg/kg), administered during the second week of a five week regimen of motivational enhancement therapy.	Active Group: Ketamine+MET n=17 participants at risk 50-minute intravenous infusion of ketamine (0.71 mg/kg) vs. 2) administered during the second week of a five week regimen of motivational enhancement therapy.
Nervous system disorders Sedation	52.2% 12/23 • Adverse event data were collected throughout the study period and at 6 months follow up	47.1% 8/17 • Adverse event data were collected throughout the study period and at 6 months follow up
Vascular disorders Headache	17.4% 4/23 • Adverse event data were collected throughout the study period and at 6 months follow up	35.3% 6/17 • Adverse event data were collected throughout the study period and at 6 months follow up
Psychiatric disorders Mild agitation	0.00% 0/23 • Adverse event data were collected throughout the study period and at 6 months follow up	11.8% 2/17 • Adverse event data were collected throughout the study period and at 6 months follow up

Additional Information

Elias Dakwar, MD

New York State Psychiatric Institute

Phone: 6467748728

Email: elias.dakwar@nyspi.columbia.edu

Results disclosure agreements

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