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

NCT ID: NCT04412824

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2021-12-31

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.

Detailed Description

Results from the 2014 National Survey on Drug Use and Health show that 26% of adults in the US engaged in binge drinking in the past month (SAMHSA 2014). Why some people "mature out" of this behavior while others persist may be due to one's physiological response to binge drinking. No previous study has assessed whether disrupted cortisol and neural network responses to alcohol cues may drive the compulsive alcohol consumption seen in binge drinking individuals who do not yet have an AUD.

The investigator will recruit beer drinking, non-smoking men and women ages 21-45 (N=80, equal gender) who are either moderate drinkers or binge/heavy drinkers for two neuroimaging and neuroendocrine assessments to determine if their "real world" drinking behavior, in a prospective one month follow up, can be predicted based upon the cortisol and neural network responses to alcohol cues (with a placebo control, counter-balanced and randomized). Finally, the influence of genetic variation in the FK506-binding protein 5 (FKBP5) gene, which regulates cortisol activity, on the cortisol and neural network responses to alcohol cues will be explored.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Alcohol Beverage Cues

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

Group Type: ACTIVE_COMPARATOR

Intravenous blood draw

Intervention Type: DRUG

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 Cues

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

Group Type: PLACEBO_COMPARATOR

Intravenous blood draw

Intervention Type: DRUG

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

Interventions

Intravenous blood draw

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

Other Intervention Names

Indwelling catheter for blood draws

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
• 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.

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Sara K Blaine

Assistant Professsor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara K Blaine, PhD

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Locations

Auburn University MRI Center

Auburn, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37484196 (View on PubMed)

Other Identifiers

R00AA025401

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-263 MR 1907

Identifier Type: -

Identifier Source: org_study_id