NCT07251283 Food Insecurity and Eating Behavior Among Adults Receiving Buprenorphine or Methadone Maintenance Treatment: Pilot Study 2
| NCT ID | NCT07251283 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Vermont |
| Condition | Food Security |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-11-07 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to evaluate the effects of a novel, mail-based meal delivery intervention among individuals receiving MOUD on household food security status. The main question it aims to answer is: * Will participants randomized to the NE+MD intervention will demonstrate greater reductions in USDA FSS scores from intake to Study Week 24 than NE participants? Participants with OUD and FI will be randomly assigned to one of two 24-week experimental conditions: Nutritional Education alone (NE) or NE + Meal Delivery (NE+MD). NE control participants will receive brief NE, a list of FI-related resources in their community, and assistance with contacting any resources of interest. NE+MD participants will receive the same educational platform plus commercial weekly meal deliveries directly to the participant's home (6 meals per week per household member). All participants will complete monthly follow-up assessments throughout the 24-week study measuring food security status, psychosocial functioning, and biometric measures of health. All participants will also complete monthly follow-up assessments for 6 months post-intervention.
Eligibility Criteria
Inclusion Criteria: * \>18 years old * receiving methadone or buprenorphine treatment for OUD * meet criteria for current FI as measured by the 18-item US Household Food Security Survey (FSS; Economic Research Service, USDA, 2012) Exclusion Criteria: * Significant psychiatric or medical illness * Pregnant or nursing
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07251283 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Food Security. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07251283 currently recruiting?
Yes, NCT07251283 is actively recruiting participants. Contact the research team at ssigmon@uvm.edu for enrollment information.
Where is the NCT07251283 trial being conducted?
This trial is being conducted at Burlington, United States.
Who is sponsoring the NCT07251283 clinical trial?
NCT07251283 is sponsored by University of Vermont. The trial plans to enroll 40 participants.