Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder
NCT06374303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-11-24
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; p=.68). Intervention acceptability was also high, with NE+MD participants rating the enjoyment and convenience of the meals at 81 and 93, respectively (range: 0-100).
Changes in FI status were also associated with improvements in other areas of functioning. NE+MD participants experienced reductions in depression symptomatology, with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 (p's\<.05) and no changes among NE participants. NE+MD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey (i.e., General Health, Bodily Pain, Mental Health, Role Emotional; p's\<.05), with no changes among NE participants.
This study represents the first effort to develop and evaluate a novel intervention to reduce FI and related problems among individuals with OUD. These pilot data support the feasibility, acceptability and initial efficacy of the NE+MD intervention for improving household FI, as well as provide exciting new preliminary evidence suggesting that FI may be linked to participants' mental and physical health.
Conditions
- Food Security
Interventions
- OTHER
-
NE + Meal Delivery (NE+MD) intervention
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.
Sponsors & Collaborators
-
University of Vermont
lead OTHER
Principal Investigators
-
Stacey Sigmon, Ph.D. · University of Vermont
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-19
- Primary Completion
- 2023-11-20
- Completion
- 2023-11-20
Countries
- United States
Study Locations
More Related Trials
-
Start Treatment and Recovery for Opioid Use Disorder
NCT04505540 ·Status: COMPLETED ·Phase: NA
-
Interim Buprenorphine: Leveraging Medication + Technology to Bridge Delays in Treatment Access
NCT02360007 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Contingency Management to Improve Medication for Opioid Use Disorder Continuation After the Emergency Department
NCT07129902 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
NCT02230722 ·Status: COMPLETED ·Phase: PHASE1
-
Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder
NCT04257214 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.
NCT06323824 ·Status: RECRUITING ·Phase: PHASE4
-
Emergency Department Outcomes for Patients With Opioid Use Disorder
NCT04289363 ·Status: COMPLETED
-
Clinical Decision Support to Implement ED-initiated Buprenorphine for OUD
NCT03658642 ·Status: COMPLETED ·Phase: NA
-
A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment
NCT05189223 ·Status: RECRUITING ·Phase: NA
-
Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation
NCT03420313 ·Status: UNKNOWN ·Phase: PHASE2
-
Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment
NCT06454903 ·Status: RECRUITING ·Phase: NA
-
Usability Testing for the Reward-based Technology to Improve OUD Treatment
NCT05159362 ·Status: COMPLETED ·Phase: NA
-
Mobile Intervention for Young Opioid Users
NCT03610672 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of a Peer Recovery Support Program Adapted to Target Retention in Clinic-based Medication for Opioid Use Disorder Treatment
NCT07197801 ·Status: RECRUITING ·Phase: NA
-
Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
NCT03367234 ·Status: WITHDRAWN ·Phase: NA
-
Psilocybin for Opioid Use Disorder (OUD)
NCT06796062 ·Status: RECRUITING ·Phase: PHASE2
-
Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder
NCT03544112 ·Status: COMPLETED
-
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
NCT00367302 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Improving Access to Opioid Use Disorder Treatment Among Marginalized Patients With a Tailored Telehealth Intervention
NCT06341608 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Onsite Buprenorphine Treatment at Syringe Exchange Programs
NCT03150173 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing Two Training Methods for Opioid Wizard
NCT04867382 ·Status: COMPLETED ·Phase: NA
-
The Impact of Methadone Maintenance Therapy on Food Reward Processing in Opioid Dependence
NCT03575273 ·Status: COMPLETED ·Phase: NA
-
Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase
NCT04248933 ·Status: COMPLETED ·Phase: NA
-
Improving Office Based Treatment of Opioid Use Disorder With Technology
NCT03586466 ·Status: UNKNOWN ·Phase: NA
-
Patient Reported Outcomes for Opioid Use Disorder
NCT03985163 ·Status: COMPLETED