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

Sponsor
Syracuse University (Other)
Overall Status
Completed
CT.gov ID
NCT03311594
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
379
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8
37.6
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Low Alcohol
  • Drug: Moderate Alcohol
  • Drug: Placebo Alcohol
  • Other: Pain Induction
  • Other: No Pain Induction
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
379 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
Actual Study Start Date :
May 12, 2019
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Drug: Moderate Alcohol
Moderate Alcohol Consumption

Other: No Pain Induction
Water placed on forearm

Experimental: Moderate Alcohol Consumption and Pain Induction

Condition 1: Moderate alcohol consumption Condition 2: Pain group

Drug: Moderate Alcohol
Moderate Alcohol Consumption

Other: Pain Induction
10% capsaicin solution placed on forearm and heat induction

Placebo Comparator: Placebo Alcohol Consumption and No Pain Induction

Condition 1: Placebo alcohol consumption Condition 2: No pain group

Drug: Placebo Alcohol
Placebo Alcohol Consumption

Other: No Pain Induction
Water placed on forearm

Experimental: Placebo Alcohol Consumption and Pain Induction

Condition 1: Placebo alcohol consumption Condition 2: Pain group

Drug: Placebo Alcohol
Placebo Alcohol Consumption

Other: Pain Induction
10% capsaicin solution placed on forearm and heat induction

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

Outcome Measures

Primary Outcome Measures

  1. Alcohol Urge/Consumption [15 minutes]

    Amount of alcohol consumed and self-reported urge to drink

  2. Pain Response [40 minutes]

    Pain Quantitative Sensory Testing before and after beverage consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 64 Years
Sexes Eligible for Study:
All
Accepts 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Syracuse University Syracuse New York United States 13210

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joseph W. Ditre, Professor, Syracuse University
ClinicalTrials.gov Identifier:
NCT03311594
Other Study ID Numbers:
  • 5R01AA024844-02
  • 5R01AA024844
First Posted:
Oct 17, 2017
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Joseph W. Ditre, Professor, Syracuse University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022