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Ketamine/Placebo Family History Positive Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588952
First Posted: January 9, 2008
Last Update Posted: March 3, 2017
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.
Collaborators:
VA Connecticut Healthcare System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University
December 27, 2007
January 9, 2008
January 10, 2017
 
March 3, 2017
March 2001
June 2015   (Final data collection date for primary outcome measure)
  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation [ Time Frame: Baseline ]
    Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol
  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation [ Time Frame: 15 minutes ]
    Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol
  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation [ Time Frame: 45 minutes ]
    Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol
  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation [ Time Frame: 80 minutes ]
    Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol
  • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation [ Time Frame: Baseline ]
    Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol
  • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation [ Time Frame: 15 minutes ]
    Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol
  • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation [ Time Frame: 45 minutes ]
    Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol
  • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation [ Time Frame: 80 minutes ]
    Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol
Not Provided
Complete list of historical versions of study NCT00588952 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ketamine/Placebo Family History Positive Study
NMDA Dysregulation in Individuals With a Family Vulnerability to Alcoholism
The proposed study is the first to explore the contribution of brain glutamate systems, a major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study may lead to an enhanced understanding of the underlying neurobiological mechanism in high-risk individuals that may lead to the transition from moderate to excessive use of alcohol.

Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to decrease dysphoric responses to alcohol self-administration that may promote the excessive use of alcohol. Ethanol has been shown to be an antagonist at the N-methyl-D-aspartate (NMDA) glutamate receptor. We have recently shown that sober alcoholics have decreased dysphoric response to the NMDA antagonist, ketamine. We propose to test the hypothesis that this characteristic exists as a vulnerability factor in those individuals susceptible to develop alcoholism. Specifically, the objective is to determine whether individuals with a family history positive (FHP) for alcoholism will experience less dysphoric, anxiogenic, and psychotogenic effects to ketamine infusion when compared to family history negative (FHN) control subjects.

Male and female subjects, FHP (biological father and one other first degree relative) between the ages of 21-30, and matched controls (FHN) will complete 2 test days in a randomized balanced order under double-blind conditions. Test days will involve the 60-minute intravenous infusion of placebo and ketamine. Outcome measures include the Biphasic Alcohol Scale and visual analog scales for mood states. Secondary measures include visual analog scales for high, similarity to ethanol, the Sensation Scale (a validated measure of ethanol-like sensations) and aspects of craving for alcohol.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Alcoholism
Drug: 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
Other Name: intravenous
  • Experimental: Family History Positive
    Subjects with a positive family history of alcoholism
    Intervention: Drug: Ketamine and Placebo
  • Experimental: Family History Negative
    Subjects with a negative family history of alcoholism
    Intervention: Drug: Ketamine and Placebo
Yoon G, Pittman B, Limoncelli D, Krystal JH, Petrakis IL. Familial Alcoholism Risk and the Ratio of Stimulant to Sedative Effects of Ketamine. Biol Psychiatry. 2016 May 1;79(9):e69-70. doi: 10.1016/j.biopsych.2015.09.006. Epub 2015 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male and female between the ages of 21 and 30 years
  2. Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories, absence of current and/or past substance abuse

For Family History Positive (FHP) Subjects: Biological father and another first or second-degree biological relative with history of alcoholism

Exclusion Criteria:

  1. Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) psychiatric and substance abuse diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (The Semi-Structured Assessment for the Genetics of alcoholism: SSAGA) and the Wisconsin Scales of Psychosis Proneness
  2. History of counseling or psychotherapy; except family therapy centered around another family member
  3. Extended unwillingness to remain alcohol-free for three days prior to testing and for the duration of the testing period
  4. For women: positive pregnancy test at screening or intention to engage in unprotected sex during the study
  5. Alcohol naïve
  6. Previous bad experience with ketamine
  7. Adoptee and no contact with family members

For Family History Negative (FHN) Subjects: NO family history of alcoholism in any first or second-degree relatives (subjects must reliably report on three first-degree relatives)

Sexes Eligible for Study: All
21 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00588952
0103012310
VA Alcohol Research Center ( Other Grant/Funding Number: VA Alcohol Research Center Grant )
P50AA012870 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Yale University
Yale University
  • VA Connecticut Healthcare System
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Ismene L. Petrakis, MD Yale University
Yale University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP