Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation

NCT04412824 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 19-263 MR 1907R00AA025401
• Study Type: interventional
• Target: 87
• 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 visual ethanol cues, followed by 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, alcohol craving, and alcohol stimulant and sedative effects. This knowledge could be significant in developing new therapies for the treatment of alcoholism.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (4)

• Change in Neural 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 visual alcohol or non-alcoholic beverage 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.

  During the Procedure: measurements taken at 10, 20, 30 and 45 minutes during 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.

  Before Procedure to 125 minutes after the procedure.

• Drinking Behavior in daily experience outside of laboratory

  A smartphone app will be used to collect 4 surveys a day for 30 days after completion of both arms. Multilevel modeling will be used to analyze patterns of drinking over time.

  Day after Procedure to 30 days after procedure.

• Amount of Alcohol Consumed

  After exposure to alcoholic beverage and non-alcoholic beverage visual cues, quantity of alcohol consumed in a free choice test will be measured in milliliters.

  Immediately after the procedure.

Secondary Outcomes (3)

• Changes in Alcohol Urges (AUQ)

  Before Procedure to 125 minutes after the procedure.

• Stress levels in daily experience outside of laboratory

  Post follow-up procedure (30 days)

• Genetic Risk Factors (Single Nucleotide Polymorphisms; SNPs) Association with Cerebral Blood Flow, Craving, and Real world drinking and stress

  Post follow up procedure (within 2 years after procedure)

Study Arms (2)

Alcohol Beverage Cues

ACTIVE COMPARATOR

Participants will complete an MRI with alcohol beverage visual cues and oral alcohol session.

Drug: Intravenous blood draw

Non-Alcoholic Beverage Cues

PLACEBO COMPARATOR

Participants will complete an MRI with non-alcoholic beverage cues and oral alcohol session.

Drug: Intravenous blood draw

Interventions

Intravenous blood draw DRUG

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

Also known as: Indwelling catheter for blood draws

Alcohol Beverage Cues; Non-Alcoholic Beverage Cues

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
• Provide negative urine toxicology screens during initial appointments and at admission for IV/fMRI sessions.
• Body Mass Index between 20-35.
• 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

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

Study Sites (1)

Auburn University MRI Center

Auburn, Alabama, 36832, United States

Location

Related Publications (1)

• Blaine SK, Ridner CM, Campbell BR, Crone L, Claus ED, Wilson JR, West SN, McClanahan AJ, Siddiq AS, Layman IMP, Macatee R, Ansell EB, Robinson JL, Beck DT. IL-6, but not TNF-alpha, response to alcohol cues and acute consumption associated with neural cue reactivity, craving, and future drinking in binge drinkers. Brain Behav Immun Health. 2023 Jun 11;31:100645. doi: 10.1016/j.bbih.2023.100645. eCollection 2023 Aug.

  PMID: 37484196 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Catheters, Indwelling; Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sara K Blaine, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professsor

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: June 2, 2020
• Study Start: May 22, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)