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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Drinking Behavior; Pain; Acute Pain
• Intervention / Treatment: Drug: Low Alcohol; Other: No Pain Induction; Other: Pain Induction; Drug: Moderate Alcohol; Drug: Placebo Alcohol

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • Syracuse University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Alcohol Consumption and No Pain Induction; Condition 1: Low alcohol consumption Condition 2: No pain group	Drug: Low Alcohol; Low Alcohol Consumption; Other: No Pain Induction; Water placed on forearm
Experimental: Low Alcohol Consumption and Pain Induction; Condition 1: Low alcohol consumption Condition 2: Pain group	Drug: Low Alcohol; Low Alcohol Consumption; Other: Pain Induction; 10% capsaicin solution placed on forearm and heat induction
Experimental: Moderate Alcohol Consumption and No Pain Induction; Condition 1: Moderate alcohol consumption Condition 2: No pain group	Other: No Pain Induction; Water placed on forearm; Drug: Moderate Alcohol; Moderate Alcohol Consumption
Experimental: Moderate Alcohol Consumption and Pain Induction; Condition 1: Moderate alcohol consumption Condition 2: Pain group	Other: Pain Induction; 10% capsaicin solution placed on forearm and heat induction; Drug: Moderate Alcohol; Moderate Alcohol Consumption
Placebo Comparator: Placebo Alcohol Consumption and No Pain Induction; Condition 1: Placebo alcohol consumption Condition 2: No pain group	Other: No Pain Induction; Water placed on forearm; Drug: Placebo Alcohol; Placebo Alcohol Consumption
Experimental: Placebo Alcohol Consumption and Pain Induction; Condition 1: Placebo alcohol consumption Condition 2: Pain group	Other: Pain Induction; 10% capsaicin solution placed on forearm and heat induction; Drug: Placebo Alcohol; Placebo Alcohol Consumption
Placebo Comparator: Control and No Pain Induction; Condition 1: No alcohol consumption Condition 2: No pain group	Other: No Pain Induction; Water placed on forearm
Experimental: Control and Pain Induction; Condition 1: No alcohol consumption Condition 2: Pain group	Other: Pain Induction; 10% capsaicin solution placed on forearm and heat induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Urge/Consumption	Amount of alcohol consumed and self-reported urge to drink	15 minutes
Pain Response	Pain Quantitative Sensory Testing before and after beverage consumption	40 minutes

Collaborators and Investigators

• Sponsor: Syracuse University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Alcohol
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Alcohol Drinking; Acute Pain; Drinking Behavior; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: 5R01AA024844-02 (U.S. NIH Grant/Contract); 5R01AA024844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes