The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
2 other identifiers
interventional
379
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pain
Started May 2019
Longer than P75 for phase_1 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedStudy Start
First participant enrolled
May 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 17, 2022
August 1, 2022
3.1 years
October 11, 2017
August 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Alcohol Urge/Consumption
Amount of alcohol consumed and self-reported urge to drink
15 minutes
Pain Response
Pain Quantitative Sensory Testing before and after beverage consumption
40 minutes
Study Arms (8)
Low Alcohol Consumption and No Pain Induction
EXPERIMENTALCondition 1: Low alcohol consumption Condition 2: No pain group
Low Alcohol Consumption and Pain Induction
EXPERIMENTALCondition 1: Low alcohol consumption Condition 2: Pain group
Moderate Alcohol Consumption and No Pain Induction
EXPERIMENTALCondition 1: Moderate alcohol consumption Condition 2: No pain group
Moderate Alcohol Consumption and Pain Induction
EXPERIMENTALCondition 1: Moderate alcohol consumption Condition 2: Pain group
Placebo Alcohol Consumption and No Pain Induction
PLACEBO COMPARATORCondition 1: Placebo alcohol consumption Condition 2: No pain group
Placebo Alcohol Consumption and Pain Induction
EXPERIMENTALCondition 1: Placebo alcohol consumption Condition 2: Pain group
Control and No Pain Induction
PLACEBO COMPARATORCondition 1: No alcohol consumption Condition 2: No pain group
Control and Pain Induction
EXPERIMENTALCondition 1: No alcohol consumption Condition 2: Pain group
Interventions
Low Alcohol Consumption
Moderate Alcohol Consumption
Placebo Alcohol Consumption
10% capsaicin solution placed on forearm and heat induction
Water placed on forearm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Syracuse University
Syracuse, New York, 13210, United States
Related Publications (1)
Ditre JW, LaRowe LR, Powers JM, White KM, Paladino MB, Zvolensky MJ, Glatt S, Maisto SA. Pain as a causal motivator of alcohol consumption: Associations with gender and race. J Psychopathol Clin Sci. 2023 Jan;132(1):101-109. doi: 10.1037/abn0000792. Epub 2022 Dec 8.
PMID: 36480413DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 11, 2017
First Posted
October 17, 2017
Study Start
May 12, 2019
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
August 17, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share