Clinical trial NCT03311594: The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
Official title: The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Alcohol Drinking
Acute Pain
Drinking Behavior
Keywords: Alcohol
Pain
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-10-17
Enrollment: 379
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Alcohol Urge/Consumption
timeFrame: 15 minutes
measure: Pain Response
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References: