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NCT03311594 · ClinicalTrials.gov registry record · Phase 1
The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
A Phase 1 study, sponsored by Syracuse University.
- Completed
- Registry status
- Phase 1
- Development phase
- 379
- Enrollment target
NCT03311594: Completed Phase 1 study, sponsored by Syracuse University.
NCT03311594 is a Phase 1 study that has completed, run by Syracuse University. The registered enrollment target is 379 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (532% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03311594, a Phase 1 study, has completed, sponsored by Syracuse University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 379 participants
- Enrollment target
Study 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 pl
Primary Outcome
Amount of alcohol consumed and self-reported urge to drink
Interventions
- DRUG Placebo Alcohol
- DRUG Low Alcohol
- DRUG Moderate Alcohol
- OTHER Pain Induction
- OTHER No Pain Induction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 379 participants |
| Start Date | 2019-05-12 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 1 |
What the finished NCT03311594 record still lists
NCT03311594 is an interventional study that assigns participants to a tested intervention. The registered 379 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (532% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo Alcohol is the first listed.
NCT03311594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03311594 about?
NCT03311594 is a clinical study titled "The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates". 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 c...
What is the current status of trial NCT03311594?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 379 participants. The study started on 2019-05-12. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03311594?
The interventions under investigation include: Placebo Alcohol (DRUG), Low Alcohol (DRUG), Moderate Alcohol (DRUG), Pain Induction (OTHER), No Pain Induction (OTHER).
Who is sponsoring clinical trial NCT03311594?
This trial is sponsored by Syracuse University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03311594's enrollment target sits among peer trials
379 84th of 2000 higher than 1,917 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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