Neuroendocrine Response to Intravenous Alcohol Administration


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Verified May 2017 by Yale University

Sponsor:

Information provided by (Responsible Party):

Yale University

ClinicalTrials.gov Identifier:

NCT03165942

First received: May 19, 2017

Last updated: May 22, 2017

Last verified: May 2017

This study proposes to examine both the peripheral and central nervous system responses when light social drinkers and binge/heavy social drinkers are exposed to intravenous infusion of ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral blood flow and functional connectivity) underlying the association between stress, cortisol release, heart rate variability, alcohol craving, and alcohol stimulant and sedative effects. This knowledge could be significant in developing new therapies for the treatment of alcoholism.

Alcohol Abuse Other: Alcoholic Beverage
Other: Non-Alcoholic Beverage
Drug: Ethanol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Basic Science
Official Title: Neuroendocrine Response to Intravenous Alcohol Administration

Primary Outcome Measures:

  • Change in Blood Flow [ Time Frame: End of Procedure (45 minutes) ]

    Blood flow is measured in ml/100 grams/minute. The interpretation is that blood flow to that area indicates that region of the brain is responding to the consumption of alcohol or alcohol cues. Change in blood flow will be calculated as the change (and slope) of measurements taken at 10, 20, 30 and 45 minutes during the procedure.

  • Change in Cortisol [ Time Frame: Post follow up to Procedure (125 minutes) ]

    The units for cortisol are micrograms/deciliter and the interpretation is that amount has been released into the blood stream from the HPA axis in response to alcohol or alcohol cues. Change in Cortisol will be calculated by taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.

Secondary Outcome Measures:

  • Changes in Alcohol Effects (BAES) [ Time Frame: Post follow up to Procedure (125 minutes) ]

    Alcohol effects will be measured using the Biphasic Alcohol Effects Scale (BAES). The BAES is a 12 item questionnaire with a 12-120 range. The higher the total value (up to 120), the greater the measured effects of alcohol. The change in alcohol effects will be assessed with the taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.

  • Changes in Alcohol Effects (DEQ) [ Time Frame: Post follow up to Procedure (125 minutes) ]

    Alcohol effects will be measured using the Drug Effects Questionnaire (DEQ). The DEQ consists of 5 questions with 5-25 total point distribution. The greater the total points, the greater the measured effect of alcohol. The change in alcohol effects will be assessed with the taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.

  • Changes in Alcohol Urges (AUQ) [ Time Frame: Post follow up to Procedure (125 minutes) ]

    The urge to consume alcohol will be measured using the Alcohol Urge Questionnaire (AUQ). The AUQ consists of 8 questions 8-56 total point distribution. The greater the total points, the greater the measured urge to consume alcohol. The change in alcohol urge will be assessed with the taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.

Estimated Enrollment: 200
Actual Study Start Date: September 8, 2016
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Experimental: Alcoholic Beverage

Participants will complete an MRI and intravenous or oral ethanol infusion (MR/IV) session.

Other: Alcoholic Beverage

Two antecubital IV lines will be placed, one in each arm, with one for infusion of ethanol and the other for drawing of blood during the MRI and intravenous ethanol infusion (MR/IV) session.

Drug: Ethanol

Placebo Comparator: Non-Alcoholic Beverage

Participants will complete an MRI and intravenous or oral ethanol infusion (MR/IV) session.

Other: Non-Alcoholic Beverage

Two antecubital IV lines will be placed, one in each arm, with one for infusion of ethanol and the other for drawing of blood during the MRI and intravenous ethanol infusion (MR/IV) session.

Drug: Ethanol

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Binge/Heavy Social Drinkers (HSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of at least 10 drinks per week, including at lease one occasion per week consuming >4 drinks (males) or >3 drinks (females).
  • Able to read and write English.
  • Light Social Drinkers (LSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of 1-3 drinks per occasion, 1-3 times weekly, with no more than one occasion per month of drinking >4 drinks (male) or >3 drinks (females) (King et al., 2002).
  • Do not meet criteria for any Axis I DSM-IV psychiatric diagnoses except for individuals with a past diagnosis of Post-Traumatic Stress Disorder, Major Depressive Disorder, or Obsessive Compulsive Disorder; and provide negative urine toxicology screens during initial appointments and at admission for IV/fMRI sessions.
  • Body Mass Index between 20-28.
  • No current or former nicotine dependence.

Exclusion Criteria:

  • Meet current criteria for dependence on any psychoactive substance, excluding caffeine.
  • Current or past history of alcohol dependence or abuse.
  • Any current use of opiates or past history of opiate abuse/dependence.
  • Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
  • Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
  • Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
  • Peri and post menopausal women, and those with hysterectomies.
  • Pregnant and lactating women will be excluded.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03165942

Yale University
New Haven, Connecticut, United States, 06519
Contact: Sara K Blaine, PhD    203-737-3436    Sara.Blaine@yale.edu   

Yale University

Principal Investigator: Sara Blaine, PhD Addictions, Division of Yale Stress Center
Principal Investigator: Rajita Sinha, PhD Foundations Fund Professor of Psychiatry and Professor in the Child Study Center and of Neuroscience; Director, Yale Interdisciplinary Stress Center; Chief, Psychology Section in Psychiatry; Co-director of Education, Yale Center for Clinical Investigation

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03165942     History of Changes
Other Study ID Numbers: 1502015387
Study First Received: May 19, 2017
Last Updated: May 22, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2017