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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 is a Phase 1 study that has completed, run by Syracuse University. The registered enrollment target is 379 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03311594
The ClinicalTrials.gov registry entry for NCT03311594 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 379 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syracuse University, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo Alcohol is the first listed.
NCT03311594 reports 0 study locations.
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.
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