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NCT Number: NCT07251283

Food Insecurity and Eating Behavior Among Adults Receiving Buprenorphine or Methadone Maintenance Treatment: Pilot Study 2

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05401, United States

Location status: Recruiting

Location contact

Stacey Sigmon, Ph.D.

CONTACT

[email protected]

802-656-9987

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NE + Meal Delivery (NE+MD) intervention

Other

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.

Primary outcomes

  1. Household food insecurity

    Time frame: Monthly during the 6-month intervention period and monthly during the 6-month post-intervention follow-up monitoring period

    Household food insecurity as measured by the USDA Household Food Security Survey (FSS)

Study contacts

Contact information is provided by the study sponsor or research team.

Stacey Sigmon, Ph.D.

CONTACT

[email protected]

802-656-9987

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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