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Completed

NCT Number: NCT03311594

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.

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Key information

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Syracuse University

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be 21-64 years of age
  • 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

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

Treatment and study plan

Low Alcohol

Drug

Low Alcohol Consumption

Moderate Alcohol

Drug

Moderate Alcohol Consumption

placebo alcohol

Drug

Placebo Alcohol Consumption

Pain Induction

Other

10% capsaicin solution placed on forearm and heat induction

No Pain Induction

Other

Water placed on forearm

Primary outcomes

  1. Alcohol Urge/Consumption

    Time frame: 15 minutes

    Amount of alcohol consumed and self-reported urge to drink

  2. Pain Response

    Time frame: 40 minutes

    Pain Quantitative Sensory Testing before and after beverage consumption

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2017
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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