Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373124
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cocaine Use Disorders
Intervention Drug: infusion of NMDA antagonist
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-label
Hide Arm/Group Description

52 minute infusion of NMDA antagonist

infusion of NMDA antagonist: 52 minute infusion

Period Title: Overall Study
Started 4
Completed 3
Not Completed 1
Arm/Group Title Open-label
Hide Arm/Group Description

52 minute infusion of NMDA antagonist

infusion of NMDA antagonist: 52 minute infusion

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
50.5
(48 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
1.Primary Outcome
Title Cocaine Use
Hide Description Participants were provided choices to use up to 5 hits of cocaine on up to 2 occasions (cocaine versus money). Participants who chose cocaine (1 or more hits) during the first choice opportunity are administered a 52 minute infusion of 0.71 mg/kg ketamine the following day. Another choice opportunity occurs 24 hours later. The primary outcome is the choice participants made during these occasions
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
medically healthy, treatment-seeking cocaine dependent individuals without a history of abuse of or adverse reaction to ketamine or benzodiazepines.
Arm/Group Title Open-label
Hide Arm/Group Description:

52 minute infusion of NMDA antagonist

infusion of NMDA antagonist: 52 minute infusion

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
first choice opportunity Number Analyzed 4 participants
able to abstain
3
  75.0%
continue to use
1
  25.0%
second choice opportunity Number Analyzed 1 participants
able to abstain
1
 100.0%
continue to use
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-label
Hide Arm/Group Description

52 minute infusion of NMDA antagonist

infusion of NMDA antagonist: 52 minute infusion

All-Cause Mortality
Open-label
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Open-label
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open-label
Affected / at Risk (%)
Total   0/4 (0.00%) 
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, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02373124     History of Changes
Other Study ID Numbers: 7051
First Submitted: January 30, 2015
First Posted: February 26, 2015
Results First Submitted: January 25, 2019
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019