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Neuroendocrine Response to Oral Alcohol Administration

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alcoholic Beverage
Non-Alcoholic Beverage
Ethanol
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Abuse

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alcoholic Beverage

Non-Alcoholic Beverage

Arm Description

Participants will complete an MRI and oral alcohol session.

Participants will complete an MRI and oral non-alcoholic session.

Outcomes

Primary Outcome Measures

Change in Blood Flow
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 Amount of drink consumed (alcohol or placebo)
Amount of drink consumed (alcohol or placebo) during the Alcohol Taste Test (ATT)

Secondary Outcome Measures

Changes in Alcohol Effects (BAES)
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)
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)
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.
Change in Cortisol
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.

Full Information

First Posted
May 19, 2017
Last Updated
August 1, 2022
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03165942
Brief Title
Neuroendocrine Response to Oral Alcohol Administration
Official Title
Neuroendocrine Response to Oral Alcohol Administration
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 oral 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.
Detailed Description
This study was a single-blind, mixed Between Subjects and repeated measures across Alcohol and Placebo conditions in separate sessions in a 2 scan neuroimaging experiment. The two groups of participants were Moderate Social Drinkers and Binge/Heavy Social Drinkers, categorized on the basis of NIAA criteria for moderate non-binge and binge/heavy drinking. Subjects were randomly assigned to receive alcoholic or non-alcoholic beer in scanning condition 1 or condition 2. Before each scan, they were exposed to 3 12 Oz. alcoholic beer or 3 12 Oz. non-alcoholic beer via an Alcohol Taste Test (ATT) during which they were asked to taste the beers to determine if they were same or different. The order of the two conditions was counterbalanced and randomized across participants. Cerebral blood flow (CBF) was then measured using Arterial Spin Labeling. In addition to measuring the different effects of alcoholic beer vs. non-alcoholic beer on CBF, the investigators also measured subjective alcohol effects, alcohol craving, breath alcohol levels, cortisol, and ACTH. Statistical tests were performed to determine if these dependent measures were due to Group, Condition, or a Group x Condition interaction. Finally, the relationship between these variables and the amount of beer consumed at the second post-scan ATT was examined. The post-scan ATT only presented with the choice to drink non-alcoholic beer in order to more clearly predict behavioral motivation for alcohol from PreATT alcohol response in cortisol, CBF and subjective ratings. Data was obtained by research staff, nurse, and MRI technician who were blind to condition as were the subjects but PI and project director were not blind.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcoholic Beverage
Arm Type
Experimental
Arm Description
Participants will complete an MRI and oral alcohol session.
Arm Title
Non-Alcoholic Beverage
Arm Type
Placebo Comparator
Arm Description
Participants will complete an MRI and oral non-alcoholic session.
Intervention Type
Other
Intervention Name(s)
Alcoholic Beverage
Intervention Description
In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.
Intervention Type
Other
Intervention Name(s)
Non-Alcoholic Beverage
Intervention Description
In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.
Intervention Type
Drug
Intervention Name(s)
Ethanol
Primary Outcome Measure Information:
Title
Change in Blood Flow
Description
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.
Time Frame
End of Procedure (45 minutes)
Title
Change in Amount of drink consumed (alcohol or placebo)
Description
Amount of drink consumed (alcohol or placebo) during the Alcohol Taste Test (ATT)
Time Frame
Pre-scan ATT and immediately Post scan ATT
Secondary Outcome Measure Information:
Title
Changes in Alcohol Effects (BAES)
Description
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.
Time Frame
Post follow up to Procedure (125 minutes)
Title
Changes in Alcohol Effects (DEQ)
Description
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.
Time Frame
Post follow up to Procedure (125 minutes)
Title
Changes in Alcohol Urges (AUQ)
Description
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.
Time Frame
Post follow up to Procedure (125 minutes)
Title
Change in Cortisol
Description
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.
Time Frame
Post follow up to Procedure (125 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Blaine, PhD
Organizational Affiliation
Addictions, Division of Yale Stress Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajita Sinha, PhD
Organizational Affiliation
Professor of Psychiatry, Yale Center for Clinical Investigation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neuroendocrine Response to Oral Alcohol Administration

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