Clinical trial NCT04925076: Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia
Official title: Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Family History of Alcoholism and Sex on Alcohol Analgesia
Keywords: alcohol effects
pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-06-14
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Primary purpose: BASIC_SCIENCE

Brief summary: Self-medication of pain with alcohol is a common, yet risky, behavior. Evidence suggests family history of alcoholism may affect the degree to which alcohol use relieves pain, but the independent contributions of expectation and conditioning have not been previously studied. Interactive effects of sex and family history are also currently unclear. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.


Eligibility criteria: Inclusion Criteria:

- Consume at least 1 drink/month over the past 6 months

Exclusion Criteria:

* History of chronic pain
* Current use of opioids
* Current major depression
* History of any psychotic disorder
* Undercontrolled hypertension or diabetes
* History of neurologic disease
* History of serious medical illness
* History of drug or alcohol dependence, including nicotine, or a pattern of hazardous alcohol use
* Safety concerns related to MRI (for example, implants or pacing devices)

Primary outcomes:
measure: Heat Pain Threshold
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Heat Pain Tolerance
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Heat Pain Intensity Ratings
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Perceived Pain Relief
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Dorsolateral Prefrontal Cortex Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Hypothalamus Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours
measure: Medial Prefrontal Cortex Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Nucleus Accumbens Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Periaqueductal Gray Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Anterior Cingulate Cortex Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Amgydala Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Hippocampus Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Insula Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Postcentral Gyrus Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Thalamus Activation
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Center for Pain Research and Behavioral Health at UF Health
state: Florida
Study officials:
affiliation: Assistant Professor
name: Jeff Boissoneault, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boissoneault J, Stennett B, Robinson ME. Acute alcohol intake alters resting state functional connectivity of nucleus accumbens with pain-related corticolimbic structures. Drug Alcohol Depend. 2020 Feb 1;207:107811. doi: 10.1016/j.drugalcdep.2019.107811. Epub 2019 Dec 24.
citation: Sevel L, Stennett B, Schneider V 2nd, Bush N, Nixon SJ, Robinson M, Boissoneault J. Acute Alcohol Intake Produces Widespread Decreases in Cortical Resting Signal Variability in Healthy Social Drinkers. Alcohol Clin Exp Res. 2020 Jul;44(7):1410-1419. doi: 10.1111/acer.14381. Epub 2020 Jun 18.