Neuroendocrine Response to Oral Alcohol Administration

NCT03165942 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: 15020153871R21AA025277-011K99AA025401-01A1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (2)

• 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.

  End of Procedure (45 minutes)

• Change in Amount of drink consumed (alcohol or placebo)

  Amount of drink consumed (alcohol or placebo) during the Alcohol Taste Test (ATT)

  Pre-scan ATT and immediately Post scan ATT

Secondary Outcomes (4)

• Changes in Alcohol Effects (BAES)

  Post follow up to Procedure (125 minutes)

• Changes in Alcohol Effects (DEQ)

  Post follow up to Procedure (125 minutes)

• Changes in Alcohol Urges (AUQ)

  Post follow up to Procedure (125 minutes)

• Change in Cortisol

  Post follow up to Procedure (125 minutes)

Study Arms (2)

Alcoholic Beverage

EXPERIMENTAL

Participants will complete an MRI and oral alcohol session.

Other: Alcoholic Beverage; Drug: Ethanol

Non-Alcoholic Beverage

PLACEBO COMPARATOR

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

Other: Non-Alcoholic Beverage; Drug: Ethanol

Interventions

Alcoholic Beverage OTHER

In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.

Alcoholic Beverage

Non-Alcoholic Beverage OTHER

In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.

Non-Alcoholic Beverage

Ethanol DRUG

Alcoholic Beverage; Non-Alcoholic Beverage

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Alcoholic Beverages; Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alcohols; Organic Chemicals

Study Officials

• Sara Blaine, PhD

  Addictions, Division of Yale Stress Center

  PRINCIPAL INVESTIGATOR

• Rajita Sinha, PhD

  Professor of Psychiatry, Yale Center for Clinical Investigation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 24, 2017
• Study Start: September 8, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

US (1)