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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ketamine

0.5 mg/kg of ketamine IV over 40 minutes

Ketamine: 0.5 mg/kg IV over 40 minutes

Midazolam

0.025 mg/kg IV over 40 minutes

Midazolam: 0.025 mg/kg IV over 40 minutes


Participant Flow:   Overall Study
    Ketamine   Midazolam
STARTED   27   28 
COMPLETED   27   28 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ketamine

0.5 mg/kg of ketamine IV over 40 minutes

Ketamine: 0.5 mg/kg IV over 40 minutes

Midazolam

0.025 mg/kg IV over 40 minutes

Midazolam: 0.025 mg/kg IV over 40 minutes

Total Total of all reporting groups

Baseline Measures
   Ketamine   Midazolam   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   28   55 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (2)   49  (1)   47  (1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  18.5%      9  32.1%      14  25.5% 
Male      22  81.5%      19  67.9%      41  74.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   27   28   55 


  Outcome Measures

1.  Primary:   Risk of Use/Drop Out   [ Time Frame: Over the four week period following discharge from the inpatient unit at Day 5 ]

2.  Primary:   Abstinence   [ 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: elias.dakwar@nyspi.columbia.edu



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