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

Primary Purpose

Pain, Alcohol Drinking, Acute Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low Alcohol
Moderate Alcohol
Placebo Alcohol
Pain Induction
No Pain Induction
Sponsored by
Syracuse University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Alcohol, Pain

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Syracuse University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Low Alcohol Consumption and No Pain Induction

Low Alcohol Consumption and Pain Induction

Moderate Alcohol Consumption and No Pain Induction

Moderate Alcohol Consumption and Pain Induction

Placebo Alcohol Consumption and No Pain Induction

Placebo Alcohol Consumption and Pain Induction

Control and No Pain Induction

Control and Pain Induction

Arm Description

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

Condition 1: Low alcohol consumption Condition 2: Pain group

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

Condition 1: Moderate alcohol consumption Condition 2: Pain group

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

Condition 1: Placebo alcohol consumption Condition 2: Pain group

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

Condition 1: No alcohol consumption Condition 2: Pain group

Outcomes

Primary Outcome Measures

Alcohol Urge/Consumption
Amount of alcohol consumed and self-reported urge to drink
Pain Response
Pain Quantitative Sensory Testing before and after beverage consumption

Secondary Outcome Measures

Full Information

First Posted
October 11, 2017
Last Updated
August 16, 2022
Sponsor
Syracuse University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03311594
Brief Title
The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
Official Title
The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Alcohol Drinking, Acute Pain, Drinking Behavior
Keywords
Alcohol, Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
379 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Alcohol Consumption and No Pain Induction
Arm Type
Experimental
Arm Description
Condition 1: Low alcohol consumption Condition 2: No pain group
Arm Title
Low Alcohol Consumption and Pain Induction
Arm Type
Experimental
Arm Description
Condition 1: Low alcohol consumption Condition 2: Pain group
Arm Title
Moderate Alcohol Consumption and No Pain Induction
Arm Type
Experimental
Arm Description
Condition 1: Moderate alcohol consumption Condition 2: No pain group
Arm Title
Moderate Alcohol Consumption and Pain Induction
Arm Type
Experimental
Arm Description
Condition 1: Moderate alcohol consumption Condition 2: Pain group
Arm Title
Placebo Alcohol Consumption and No Pain Induction
Arm Type
Placebo Comparator
Arm Description
Condition 1: Placebo alcohol consumption Condition 2: No pain group
Arm Title
Placebo Alcohol Consumption and Pain Induction
Arm Type
Experimental
Arm Description
Condition 1: Placebo alcohol consumption Condition 2: Pain group
Arm Title
Control and No Pain Induction
Arm Type
Placebo Comparator
Arm Description
Condition 1: No alcohol consumption Condition 2: No pain group
Arm Title
Control and Pain Induction
Arm Type
Experimental
Arm Description
Condition 1: No alcohol consumption Condition 2: Pain group
Intervention Type
Drug
Intervention Name(s)
Low Alcohol
Intervention Description
Low Alcohol Consumption
Intervention Type
Drug
Intervention Name(s)
Moderate Alcohol
Intervention Description
Moderate Alcohol Consumption
Intervention Type
Drug
Intervention Name(s)
Placebo Alcohol
Intervention Description
Placebo Alcohol Consumption
Intervention Type
Other
Intervention Name(s)
Pain Induction
Intervention Description
10% capsaicin solution placed on forearm and heat induction
Intervention Type
Other
Intervention Name(s)
No Pain Induction
Intervention Description
Water placed on forearm
Primary Outcome Measure Information:
Title
Alcohol Urge/Consumption
Description
Amount of alcohol consumed and self-reported urge to drink
Time Frame
15 minutes
Title
Pain Response
Description
Pain Quantitative Sensory Testing before and after beverage consumption
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Syracuse University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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