Mail-delivered meals plus nutrition education for adults on buprenorphine or methadone
Food Insecurity and Eating Behavior Among Adults Receiving Buprenorphine or Methadone Maintenance Treatment: Pilot Study 2
This test will see if adding weekly mail-delivered meals to brief nutrition education helps adults on buprenorphine or methadone reduce household food insecurity over 24 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Vermont Academic / other |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT07251283 on ClinicalTrials.gov |
What this trial studies
Adults receiving methadone or buprenorphine who meet criteria for current food insecurity are randomized to one of two 24-week arms: brief nutritional education (NE) alone or NE plus commercial meal deliveries (NE+MD). NE participants receive education, a list of community food resources, and assistance contacting resources; NE+MD participants receive the same package plus weekly mailed meals sized at six meals per week per household member. Monthly follow-up assessments track household food security using the 18-item USDA Food Security Survey and other measures through Study Week 24. The primary comparison is change in USDA FSS scores from baseline to week 24 between the two arms.
Who should consider this trial
Good fit: Adults aged 18 or older who are receiving methadone or buprenorphine maintenance for OUD and meet current food insecurity on the 18-item USDA Food Security Survey are ideal candidates.
Not a fit: People who are not currently food insecure, who are pregnant or nursing, who have significant uncontrolled psychiatric or medical illness, or who lack a stable address for meal delivery are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the combined meal-delivery and education approach could meaningfully reduce household food insecurity for people receiving medication for opioid use disorder.
How similar studies have performed: Meal-delivery and food-assistance programs have shown benefit for food insecurity in general populations, but this specific mailed-meal plus education approach is relatively novel for people receiving MOUD and has limited prior randomized data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Burlington, Vermont
- University of Vermont — Burlington, Vermont, United States (Recruiting)
Study contacts
- Study coordinator: Stacey Sigmon, Ph.D.
- Email: ssigmon@uvm.edu
- Phone: 802-656-9987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.