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Ketamine/Placebo Family History Positive Study

This study has been completed.
Sponsor:
Collaborators:
VA Connecticut Healthcare System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00588952
First received: December 27, 2007
Last updated: January 10, 2017
Last verified: January 2017
Results First Received: January 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Outcomes Assessor)
Condition: Alcoholism
Intervention: Drug: Ketamine and Placebo

  Participant Flow
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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
Family History Positive

Subjects with a positive family history of alcoholism

Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes

Family History Negative

Subjects with a negative family history of alcoholism

Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes


Participant Flow:   Overall Study
    Family History Positive   Family History Negative
STARTED   29   70 
COMPLETED   26   63 
NOT COMPLETED   3   7 
Adverse Event                0                2 
Withdrawal by Subject                3                5 



  Baseline Characteristics
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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.
All available data was utilized in the analysis using mixed models

Reporting Groups
  Description
Family History Positive

Subjects with a positive family history of alcoholism

Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes

Family History Negative

Subjects with a negative family history of alcoholism

Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes

Total Total of all reporting groups

Baseline Measures
   Family History Positive   Family History Negative   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   70   99 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      29 100.0%      70 100.0%      99 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.97  (3.02)   24.13  (2.34)   24.37  (2.57) 
Gender 
[Units: Participants]
Count of Participants
     
Female      13  44.8%      36  51.4%      49  49.5% 
Male      16  55.2%      34  48.6%      50  50.5% 
Region of Enrollment 
[Units: Participants]
     
United States   29   70   99 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation   [ Time Frame: Baseline ]

2.  Primary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation   [ Time Frame: 15 minutes ]

3.  Primary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation   [ Time Frame: 45 minutes ]

4.  Primary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation   [ Time Frame: 80 minutes ]

5.  Primary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation   [ Time Frame: Baseline ]

6.  Primary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation   [ Time Frame: 15 minutes ]

7.  Primary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation   [ Time Frame: 45 minutes ]

8.  Primary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation   [ Time Frame: 80 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ismene Petrakis
Organization: Yale University
phone: 203-932-5711 ext 2244
e-mail: Ismene.petrakis@yale.edu


Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00588952     History of Changes
Other Study ID Numbers: 0103012310
VA Alcohol Research Center ( Other Grant/Funding Number: VA Alcohol Research Center Grant )
P50AA012870 ( US NIH Grant/Contract Award Number )
Study First Received: December 27, 2007
Results First Received: January 10, 2017
Last Updated: January 10, 2017