Clinical Trial: Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism

Brief Summary: 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.

Detailed Summary:

Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to have decreased 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 alcohol 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 3 test days in a randomized balanced order under double-blind conditions. Test days will involve administration of placebo or one of two ethanol doses (target BrAc=40mg%, or target BrAc=100mg%) intravenously for 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for over 60 minutes. Outcome measures include the Positive and Negative Symptom Scale, visual analog scales of mood state, (i.e. anxiety) and the Clinician-Administered Dissociative States Scale (CADSS) to measure perceptual responses to alcohol. Secondary measures include visual analog scales for high, similarity to ethanol, Mini Mental Status Examination (MMSE), Placement of electrodes, Biphasic Alcohol Effects Scale, Hopkins Verbal Learning, and number of drinks scale, aspects of craving for alcohol and tests
Sponsor: Yale University

Current Primary Outcome:

  • Number of Drinks Felt Consumed at Baseline [ Time Frame: Baseline ]
    The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
  • Number of Drinks Felt Consumed at 10 Minutes [ Time Frame: 10 minutes ]
    The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
  • Number of Drinks Felt Consumed at 30 Minutes [ Time Frame: 30 minutes ]
    The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
  • Number of Drinks Felt Consumed at 110 Minutes [ Time Frame: 110 minutes ]
    The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
  • Number of Drinks Felt Consumed at 140 Minutes [ Time Frame: 140 minutes ]
    The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
  • Number of Drinks Felt Consumed at 170 Minutes [ Time Frame: 170 minutes ]
    The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
  • Number of Drinks Felt Consumed at 230 Minutes [ Time Frame: 230 minutes ]
    The Number of Drinks Scale asks Subjects to re

    Original Primary Outcome: Biphasic Alcohol Affects Scale (BAES), Positive and Negative Symptom Scale (PANSS), visual analog scales of mood states (i.e. anxiety) and the Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: Baseline, +20, +40, +80, +110, +170, +230 ]

    Current Secondary Outcome:

    • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline [ Time Frame: Baseline ]
      Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes [ Time Frame: 10 minutes ]
      Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes [ Time Frame: 30 minutes ]
      Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes [ Time Frame: 60 minutes ]
      Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes [ Time Frame: 110 minutes ]
      Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes [ Time Frame: 140 minutes ]
      Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes [ Time Frame: 170 minutes ]
      Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes [ Time Frame: 230 minutes ]
      Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline [ Time Frame: Baseline ]
      Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes [ Time Frame: 10 minutes ]
      Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes [ Time Frame: 30 minutes ]
      Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes [ Time Frame: 60 minutes ]
      Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes [ Time Frame: 110 minutes ]
      Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes [ Time Frame: 140 minutes ]
      Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes [ Time Frame: 170 minutes ]
      Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
    • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes [ Time Frame: 240 minutes ]
      Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
    • Visual Analog Scale (VAS) HIGH - Baseline [ Time Frame: Baseline ]
      visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
    • Visual Analog Scale (VAS) HIGH - 10 Minutes [ Time Frame: 10 minutes ]
      visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
    • Visual Analog Scale (VAS) HIGH - 30 Minutes [ Time Frame: 30 minutes ]
      visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
    • Visual Analog Scale (VAS) HIGH - 60 Minutes [ Time Frame: 60 minutes ]