Skip to content

The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates

The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03311594
Enrollment
379
Registered
2017-10-17
Start date
2019-05-12
Completion date
2022-06-30
Last updated
2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Alcohol Drinking, Drinking Behavior, Pain

Keywords

Alcohol, Pain

Brief summary

The societal impact of heavy alcohol consumption and chronic pain is substantial and warrants the existing research investment into their etiology and treatment. Moreover, evidence of significant co-occurrence between these conditions offers an opportunity to examine mechanisms in the alcohol-pain connection that may inform the development of novel treatments. Consistent with NIH PA-15-026 (Mechanistic Studies of Pain and Alcohol Dependence), the goal of the proposed study is to examine several complex and potentially bidirectional relations between pain and alcohol in one overarching model, which has never been attempted in a human experimental paradigm. The primary study aims are as follows: (1) to conduct the first test of both pharmacological and expectancy effects in acute alcohol analgesia among humans; (2) to conduct the first test of pain as a proximal antecedent of urge to drink and ad lib alcohol consumption, and to test whether acute analgesic effects predict pain-induced alcohol urge/consumption; (3) to test associations between study outcomes and candidate genetic polymorphisms that have been implicated in pain-alcohol processes; and (4) to conduct exploratory analyses of gender and pain relevant cognitive-affective factors as moderators of these outcomes. Participants will include 280 moderate-to-heavy drinkers recruited from the local community. Experimental methods will include alcohol administration (moderate dose vs. low dose vs. placebo vs. control) and pre/post assessment of static/dynamic pain responses, and capsaicin/heat pain induction (vs. no pain induction) followed by assessment of urge to drink and ad lib alcohol consumption. By employing a novel experimental paradigm, the study results will provide internally valid data with clear and direct implications for translating these findings to clinical applications. It is our expectation that this work will catalyze future research and inform clinical practice by establishing an experimental platform that allows for the demonstration of causal effects, the evaluation of treatment components prior to conducting costly clinical trials, and the identification of important theory-based biopsychosocial mechanisms that can inform the development of novel integrated treatments for individuals with co-occurring pain and alcohol use disorders.

Interventions

DRUGLow Alcohol

Low Alcohol Consumption

DRUGModerate Alcohol

Moderate Alcohol Consumption

Placebo Alcohol Consumption

OTHERPain Induction

10% capsaicin solution placed on forearm and heat induction

OTHERNo Pain Induction

Water placed on forearm

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Syracuse University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

1. be 21-64 years of age 2. be classified as a moderate or heavy drinker based on the Quantity-Frequency-Variability Questionnaire, which will assure that participants currently (last 3 months) consume alcohol in amounts similar to what will be administered or available in the proposed experiments

Exclusion criteria

1. current acute or chronic pain 2. chili pepper allergies (contraindicated for capsaicin) 3. current use of prescription pain medications 4. any possibility of being pregnant (verified at session via a pregnancy test) 5. self-reported history of or treatment for psychiatric or alcohol/other drug problems 6. participants who are under the age of 21 or who do not have a government issued ID; and 7. medical conditions that contraindicate the use of alcohol (e.g., diabetes, liver disease).

Design outcomes

Primary

MeasureTime frameDescription
Alcohol Urge/Consumption15 minutesAmount of alcohol consumed and self-reported urge to drink
Pain Response40 minutesPain Quantitative Sensory Testing before and after beverage consumption

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026