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NCT06374303 · ClinicalTrials.gov registry record · NA
Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder
A NA study, sponsored by University of Vermont.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT06374303 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 50 participants.
The verdict
NCT06374303, a NA study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The adverse consequences of illicit opioid use (e.g., overdose, premature death) are the focus of intensive research efforts. However, other serious health problems among individuals with opioid use disorder (OUD) have received far less attention. Food insecurity (FI) is 4-7 times greater among individuals with OUD than the general population. In addition to the increased healthcare utilization and costs, poor health outcomes, and adverse social consequences associated with FI in the general population, patients with co-occurring FI and OUD are at increased risk for licit and illicit drug use, sexual and drug risk behaviors, infectious disease, and a two-fold greater odds of premature death. In this randomized pilot study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among individuals receiving methadone or buprenorphine maintenance for OUD. Fifty adults with FI and OUD were randomized to one of two 12-week experimental conditions: Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home. The primary outcome of household FI was measured at monthly assessments using the USDA Household Food Security Survey. Secondary measures included depression symptoms (Beck Depression Inventory), quality of life (RAND-36 Quality of Life Survey), and drug use as measured by biochemical urinalysis. The NE+MD intervention was associated with significant improvements in household FI, with fewer NE+MD participants meeting criteria for FI vs. NE participants at all three assessment timepoints (p's\<.05). Retention rates were similar between the two groups (88% and 84% for NE+MD and NE conditions, respectively;
Interventions
- OTHER NE + Meal Delivery (NE+MD) intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-04-19 |
| Est. Completion | 2023-11-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06374303
The ClinicalTrials.gov registry entry for NCT06374303 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NE + Meal Delivery (NE+MD) intervention is the first listed.
NCT06374303 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06374303 about?
NCT06374303 is a clinical study titled "Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder". The adverse consequences of illicit opioid use (e.g., overdose, premature death) are the focus of intensive research efforts. However, other serious health problems among individuals with opioid use disorder (OUD) have received far less attention. Food insecurity (FI) is 4-7 times greater among indi...
What is the current status of trial NCT06374303?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2022-04-19. Estimated completion is 2023-11-20.
What interventions are being tested in trial NCT06374303?
The interventions under investigation include: NE + Meal Delivery (NE+MD) intervention (OTHER).
Who is sponsoring clinical trial NCT06374303?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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