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 : February 11, 2020
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Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Elias Dakwar, Columbia University
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Study Type | Interventional |
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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 | 50 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | 50 participants were enrolled in the study and from those, 40 were randomized. |
Arm/Group Title | Control Group: Midazolam+MET | Active Group: Ketamine+MET |
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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 |
Baseline Characteristics
Arm/Group Title | Control Group: Midazolam+MET | Active Group: Ketamine+MET | Total | |
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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 | |
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40 adults with DSM-IV alcohol dependence without significant medical or psychiatric co-morbidity.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 23 participants | 17 participants | 40 participants | |
Female |
14 60.9%
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7 41.2%
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21 52.5%
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Male |
9 39.1%
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10 58.8%
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19 47.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 17 participants | 40 participants | |
Hispanic or Latino |
3 13.0%
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4 23.5%
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7 17.5%
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Not Hispanic or Latino |
20 87.0%
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13 76.5%
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33 82.5%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 23 participants | 17 participants | 40 participants |
23 | 17 | 40 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Elias Dakwar, MD |
Organization: | New York State Psychiatric Institute |
Phone: | 6467748728 |
EMail: | elias.dakwar@nyspi.columbia.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Elias Dakwar, Columbia University |
ClinicalTrials.gov Identifier: | NCT02539511 |
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: | February 11, 2020 |