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NCT04592978 · ClinicalTrials.gov registry record · NA
Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults With Chronic Pain
A NA study, sponsored by Syracuse University.
- Completed
- Registry status
- NA
- Development phase
- 206
- Enrollment target
NCT04592978: Completed NA study, sponsored by Syracuse University.
NCT04592978 is a NA study that has completed, run by Syracuse University. The registered enrollment target is 206 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04592978, a NA study, has completed, sponsored by Syracuse University.
- COMPLETED
- Registry status
- NA
- Development phase
- 206 participants
- Enrollment target
Study Summary
Over one-quarter of American adults engage in hazardous drinking (i.e., a pattern of alcohol consumption that increases risk for harmful consequences), which is the third leading cause of preventable death in the U.S. Rates of hazardous drinking are significantly higher among individuals with (vs. without) chronic pain. Moreover, 20% of individuals prescribed opioids endorse concurrent alcohol and opioid use, which may interfere with chronic pain treatment and lead to dangerous/potentially fatal health effects. No interventions to date have targeted either hazardous drinking or concurrent use of alcohol and opioids in the context of chronic pain. The current four-year R01 builds upon our past work by developing a brief, single-session, computer-based, personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse pain-alcohol-opioid interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding concurrent use of alcohol and prescription opioid medications. Specifically, we will develop an integrated PFI for hazardous drinkers with chronic pain who are prescribed opioids (PA-PFI). Our approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral interventions. Phase IA activities will involve collecting qualitative and quantitative feedback from three iterative focus groups (N = 21) to refine intervention content and evaluate treatment acceptability and feasibility. Phase IB activities will include a proof-of-concept and highly rigorous randomized clinical trial designed to compare PA-PFI to control PFI (C-PFI) among a sample of 174 hazardous drinkers with chronic pain who are currently prescribed opioid medications. This study represents an important and pivotal step in the larger landscape of translating basic research to more efficacious strategies for reducing hazardous drinking among underserved populations with medica
Primary Outcome
Assessed via greater number of correct responses on the 10-item Pain Alcohol Opioid Knowledge Questionnaire (PAOKQ).
Interventions
- BEHAVIORAL Control Personalized Feedback Intervention
- BEHAVIORAL Pain-Alcohol Personalized Feeback Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2021-07-30 |
| Est. Completion | 2025-04-30 |
| Phase | NA |
What the finished NCT04592978 record still lists
NCT04592978 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Control Personalized Feedback Intervention is the first listed.
NCT04592978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04592978 about?
NCT04592978 is a clinical study titled "Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults With Chronic Pain". Over one-quarter of American adults engage in hazardous drinking (i.e., a pattern of alcohol consumption that increases risk for harmful consequences), which is the third leading cause of preventable death in the U.S. Rates of hazardous drinking are significantly higher among individuals with (vs. w...
What is the current status of trial NCT04592978?
This trial is currently completed. It is a NA study. The enrollment target is 206 participants. The study started on 2021-07-30. Estimated completion is 2025-04-30.
What interventions are being tested in trial NCT04592978?
The interventions under investigation include: Control Personalized Feedback Intervention (BEHAVIORAL), Pain-Alcohol Personalized Feeback Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04592978?
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 NCT04592978's enrollment target sits among peer trials
206 499th of 2000 higher than 1,502 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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