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Glutamatergic Modulation of Disordered Alcohol Use

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ClinicalTrials.gov Identifier: NCT02539511
Recruitment Status : Completed
First Posted : September 3, 2015
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Elias Dakwar, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcohol Dependence
Interventions Drug: CI-581a
Drug: CI-581b
Behavioral: Motivational Enhancement Therapy (MET)
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group: Midazolam+MET Active Group: Ketamine+MET
Hide Arm/Group Description 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. 50-minute intravenous infusion of ketamine (0.71 mg/kg) administered during the second week of a five week regimen of motivational enhancement therapy.
Period Title: Overall Study
Started 23 17
Completed 17 17
Not Completed 6 0
Arm/Group Title Control Group: Midazolam+MET Active Group: Ketamine+MET Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 23 17 40
Hide Baseline Analysis Population Description
40 adults with DSM-IV alcohol dependence without significant medical or psychiatric co-morbidity.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 17 participants 40 participants
55  (8.3) 50.4  (11.3) 53  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 17 participants 40 participants
Female
14
  60.9%
7
  41.2%
21
  52.5%
Male
9
  39.1%
10
  58.8%
19
  47.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 17 participants 40 participants
Hispanic or Latino
3
  13.0%
4
  23.5%
7
  17.5%
Not Hispanic or Latino
20
  87.0%
13
  76.5%
33
  82.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 17 participants 40 participants
23 17 40
1.Primary Outcome
Title Estimated Proportion of Alcohol Abstinence in the Control (Midazolam) Group Versus the Active (Ketamine) Group
Hide Description the model estimated proportion of alcohol abstinence in the control (midazolam) group versus the active (ketamine) group
Time Frame 21 days post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Medically healthy, treatment-seeking adults without psychiatric comorbidity and who met DSM-IV criteria for alcohol dependence and minimum use criteria.
Arm/Group Title Control Group: Midazolam+MET Active Group: Ketamine+MET
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 23 17
Measure Type: Number
Unit of Measure: percentage of participants
68.6 98.6
Time Frame Adverse event data were collected throughout the study period and at 6 months follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group: Midazolam+MET Active Group: Ketamine+MET
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Control Group: Midazolam+MET Active Group: Ketamine+MET
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group: Midazolam+MET Active Group: Ketamine+MET
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group: Midazolam+MET Active Group: Ketamine+MET
Affected / at Risk (%) Affected / at Risk (%)
Total   16/23 (69.57%)   16/17 (94.12%) 
Nervous system disorders     
Sedation †  12/23 (52.17%)  8/17 (47.06%) 
Psychiatric disorders     
Mild agitation †  0/23 (0.00%)  2/17 (11.76%) 
Vascular disorders     
Headache †  4/23 (17.39%)  6/17 (35.29%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elias Dakwar, MD
Organization: New York State Psychiatric Institute
Phone: 6467748728
EMail: elias.dakwar@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Elias Dakwar, Columbia University
ClinicalTrials.gov Identifier: NCT02539511     History of Changes
Other Study ID Numbers: 7014
R21AA023010 ( U.S. NIH Grant/Contract )
First Submitted: August 21, 2015
First Posted: September 3, 2015
Results First Submitted: January 25, 2019
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019