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

Phase 1
Completed
Conditions
Pain
Alcohol Drinking
Acute Pain
Drinking Behavior
Interventions
Other: No Pain Induction
Other: Pain Induction
Registration Number
NCT03311594
Lead Sponsor
Syracuse University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
379
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 & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Placebo Alcohol Consumption and No Pain InductionPlacebo AlcoholCondition 1: Placebo alcohol consumption Condition 2: No pain group
Placebo Alcohol Consumption and No Pain InductionNo Pain InductionCondition 1: Placebo alcohol consumption Condition 2: No pain group
Low Alcohol Consumption and No Pain InductionLow AlcoholCondition 1: Low alcohol consumption Condition 2: No pain group
Low Alcohol Consumption and Pain InductionLow AlcoholCondition 1: Low alcohol consumption Condition 2: Pain group
Low Alcohol Consumption and Pain InductionPain InductionCondition 1: Low alcohol consumption Condition 2: Pain group
Moderate Alcohol Consumption and No Pain InductionModerate AlcoholCondition 1: Moderate alcohol consumption Condition 2: No pain group
Control and Pain InductionPain InductionCondition 1: No alcohol consumption Condition 2: Pain group
Moderate Alcohol Consumption and Pain InductionPain InductionCondition 1: Moderate alcohol consumption Condition 2: Pain group
Placebo Alcohol Consumption and Pain InductionPain InductionCondition 1: Placebo alcohol consumption Condition 2: Pain group
Placebo Alcohol Consumption and Pain InductionPlacebo AlcoholCondition 1: Placebo alcohol consumption Condition 2: Pain group
Low Alcohol Consumption and No Pain InductionNo Pain InductionCondition 1: Low alcohol consumption Condition 2: No pain group
Moderate Alcohol Consumption and No Pain InductionNo Pain InductionCondition 1: Moderate alcohol consumption Condition 2: No pain group
Moderate Alcohol Consumption and Pain InductionModerate AlcoholCondition 1: Moderate alcohol consumption Condition 2: Pain group
Control and No Pain InductionNo Pain InductionCondition 1: No alcohol consumption Condition 2: No pain group
Primary Outcome Measures
NameTimeMethod
Alcohol Urge/Consumption15 minutes

Amount of alcohol consumed and self-reported urge to drink

Pain Response40 minutes

Pain Quantitative Sensory Testing before and after beverage consumption

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Syracuse University

🇺🇸

Syracuse, New York, United States

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