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The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT01535937
Recruitment Status : Terminated (An analysis demonstrated that running the final participants was unnecessary.)
First Posted : February 20, 2012
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cocaine Dependence
Interventions Drug: Ketamine
Drug: Midazolam
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description

0.5 mg/kg of ketamine IV over 40 minutes

Ketamine: 0.5 mg/kg IV over 40 minutes

0.025 mg/kg IV over 40 minutes

Midazolam: 0.025 mg/kg IV over 40 minutes

Period Title: Overall Study
Started 27 28
Completed 27 28
Not Completed 0 0
Arm/Group Title Ketamine Midazolam Total
Hide Arm/Group Description

0.5 mg/kg of ketamine IV over 40 minutes

Ketamine: 0.5 mg/kg IV over 40 minutes

0.025 mg/kg IV over 40 minutes

Midazolam: 0.025 mg/kg IV over 40 minutes

Total of all reporting groups
Overall Number of Baseline Participants 27 28 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 55 participants
45  (2) 49  (1) 47  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Female
5
  18.5%
9
  32.1%
14
  25.5%
Male
22
  81.5%
19
  67.9%
41
  74.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  51.9%
20
  71.4%
34
  61.8%
White
5
  18.5%
2
   7.1%
7
  12.7%
More than one race
4
  14.8%
6
  21.4%
10
  18.2%
Unknown or Not Reported
4
  14.8%
0
   0.0%
4
   7.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 27 participants 28 participants 55 participants
27 28 55
1.Primary Outcome
Title Risk of Use/Drop Out
Hide Description

During phase 2, patients will be assessed twice weekly by TLFB and urine toxicology for cocaine use. The day of first use will determine the length of time that transpired from discharge to the first lapse onto cocaine.

(Survival analysis of risk of first use/drop-out. Provided here as proportion of participants to use/drop-out)

Time Frame Over the four week period following discharge from the inpatient unit at Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

0.5 mg/kg of ketamine IV over 40 minutes

Ketamine: 0.5 mg/kg IV over 40 minutes

0.025 mg/kg IV over 40 minutes

Midazolam: 0.025 mg/kg IV over 40 minutes

Overall Number of Participants Analyzed 27 28
Measure Type: Count of Participants
Unit of Measure: Participants
16
  59.3%
26
  92.9%
2.Primary Outcome
Title Abstinence
Hide Description Abstinence is defined as 2 or greater weeks of no cocaine use, as ascertained by the TLFB and urine toxicology.
Time Frame Abstinence will be assessed over 4 weeks starting at the last day of week 1 and continuing through the end of study at the last day of week 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

0.5 mg/kg of ketamine IV over 40 minutes

Ketamine: 0.5 mg/kg IV over 40 minutes

0.025 mg/kg IV over 40 minutes

Midazolam: 0.025 mg/kg IV over 40 minutes

Overall Number of Participants Analyzed 27 28
Measure Type: Count of Participants
Unit of Measure: Participants
13
  48.1%
3
  10.7%
Time Frame 5 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description

0.5 mg/kg of ketamine IV over 40 minutes

Ketamine: 0.5 mg/kg IV over 40 minutes

0.025 mg/kg IV over 40 minutes

Midazolam: 0.025 mg/kg IV over 40 minutes

All-Cause Mortality
Ketamine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/27 (11.11%)      7/28 (25.00%)    
Nervous system disorders     
sedation * [1]  3/27 (11.11%)  3 7/28 (25.00%)  7
*
Indicates events were collected by non-systematic assessment
[1]
sedation persisting for more than 1 hour post-infusion
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Elias Dakwar, MD
Organization: NYSPI
Phone: 646.774.8728
Responsible Party: Elias Dakwar, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01535937     History of Changes
Other Study ID Numbers: #6403/7339R
1K23DA031771-01 ( U.S. NIH Grant/Contract )
First Submitted: December 29, 2011
First Posted: February 20, 2012
Results First Submitted: April 12, 2018
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018