Food SecurityNCT06374303
Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder
A study testing NE + Meal Delivery (NE+MD) intervention in people with Food Security, run by University of Vermont at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Security
- What is being tested?
- NE + Meal Delivery (NE+MD) intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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)
Who cannot join
- Significant psychiatric or medical illness
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- NE + Meal Delivery (NE+MD) intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NE + Meal Delivery (NE+MD) interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Education (NE) control condition | No intervention | Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. |
| Nutritional Eduction + Meal Delivery (NE+MD) experimental condition | Experimental | 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. Receives: Other: NE + Meal Delivery (NE+MD) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household food insecurity Survey
measured using the USDA Household Food Security
Measured: 3 month study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start19 Apr 2022
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-groups pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacey C. Sigmon, University of Vermont
- Investigators
- Stacey Sigmon, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374303
- Sponsor's protocol ID
- CHRBSS 00001940
- Status last verified
- Nov 2025
- First submitted
- 15 Apr 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06374303
- Acronym / sponsor ID
- CHRBSS 00001940
- Conditions
- Food Security
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel-groups pilot study
| Arm | Type | Receives |
|---|---|---|
| Nutritional Education (NE) control condition | No intervention | –Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. |
| Nutritional Eduction + Meal Delivery (NE+MD) experimental condition | Experimental | Other: NE + Meal Delivery (NE+MD) interventionNE + 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >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)
Key exclusion criteria (2 listed)
- Significant psychiatric or medical illness
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NE + Meal Delivery (NE+MD) interventionNE + 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. | Other | Nutritional Eduction + Meal Delivery (NE+MD) experimental condition |
Primary outcome
Household food insecurity Survey
Time frame: 3 month study duration
measured using the USDA Household Food Security
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Sigmon, Ph.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NE + Meal Delivery (NE+MD) intervention in people with Food Security, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household food insecurity Survey (time frame: 3 month study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.