A Phase 1 interventional study of Low Alcohol and Moderate Alcohol in Pain, Alcohol Drinking and Acute Pain, sponsored by Syracuse University. Completed at 1 site in United States. Open to participants aged 21 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Syracuse University · Phase 1, Interventional, and Basic science
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.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 379 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Syracuse University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
Compared within Acute Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Condition 1: Low alcohol consumption Condition 2: No pain group
Drug: Low Alcohol · Other: No Pain Induction
Condition 1: Low alcohol consumption Condition 2: Pain group
Drug: Low Alcohol · Other: Pain Induction
Condition 1: Moderate alcohol consumption Condition 2: No pain group
Drug: Moderate Alcohol · Other: No Pain Induction
Condition 1: Moderate alcohol consumption Condition 2: Pain group
Drug: Moderate Alcohol · Other: Pain Induction
Condition 1: Placebo alcohol consumption Condition 2: No pain group
Drug: Placebo Alcohol · Other: No Pain Induction
Condition 1: Placebo alcohol consumption Condition 2: Pain group
Drug: Placebo Alcohol · Other: Pain Induction
Condition 1: No alcohol consumption Condition 2: No pain group
Other: No Pain Induction
Condition 1: No alcohol consumption Condition 2: Pain group
Other: Pain Induction
Low Alcohol Consumption
Moderate Alcohol Consumption
Placebo Alcohol Consumption
10% capsaicin solution placed on forearm and heat induction
Water placed on forearm
Alcohol Urge/Consumption
Amount of alcohol consumed and self-reported urge to drink
Time frame: 15 minutes
Pain Response
Pain Quantitative Sensory Testing before and after beverage consumption
Time frame: 40 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2019 to primary completion in Jun 2022, 37 months.
Of 33 phase 1 interventional studies under Acute Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 17. This study's 37 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Syracuse University