Clinical trial NCT03165942: Neuroendocrine Response to Oral Alcohol Administration
Official title: Neuroendocrine Response to Oral Alcohol Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-05-24
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in Blood Flow
timeFrame: End of Procedure (45 minutes)
measure: Change in Amount of drink consumed (alcohol or placebo)
timeFrame: Pre-scan ATT and immediately Post scan ATT
Secondary outcomes:
measure: Changes in Alcohol Effects (BAES)
timeFrame: Post follow up to Procedure (125 minutes)
measure: Changes in Alcohol Effects (DEQ)
timeFrame: Post follow up to Procedure (125 minutes)
measure: Changes in Alcohol Urges (AUQ)
timeFrame: Post follow up to Procedure (125 minutes)
measure: Change in Cortisol
timeFrame: Post follow up to Procedure (125 minutes)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Addictions, Division of Yale Stress Center
name: Sara Blaine, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Psychiatry, Yale Center for Clinical Investigation
name: Rajita Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: