Clinical Trial 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.
