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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311594
• Other study ID #: 5R01AA024844-02
• Secondary ID: 5R01AA024844
• Status: Completed
• Phase: Phase 1
• Start date: May 12, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Syracuse University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Pain
• Alcohol Drinking
• Drinking Behavior
• Pain

Intervention

Drug:
• Low Alcohol
Low Alcohol Consumption
• Moderate Alcohol
Moderate Alcohol Consumption
• Placebo Alcohol
Placebo Alcohol Consumption

Other:
• Pain Induction
10% capsaicin solution placed on forearm and heat induction
• No Pain Induction
Water placed on forearm

Locations

Country	Name	City	State
United States	Syracuse University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Syracuse University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

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