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OverdoseCENSNCT05343169

Community-based Education, Navigation, and Support Intervention for Military Veterans

A study testing Overdose Education and Naloxone Distribution, Advanced Education in Safer Substance Use, Treatment, and Self-Care and Social Service and Health Navigation in people with Overdose and Opioid Use Disorder, run by New York University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Military veterans in the U.S. represent one of the populations most disproportionately impacted by the current opioid crisis. Veterans who use opioids and are not connected to the VA healthcare system have high rates of homelessness and experience higher prevalence of comorbid substance use disorder and mental health… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overdose, Opioid Use Disorder, HIV Infections
What is being tested?
Overdose Education and Naloxone Distribution, Advanced Education in Safer Substance Use, Treatment, and Self-Care and Social Service and Health Navigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
21 Oct 2022to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veteran status
  • Adult (18+) age
  • Current nonmedical use of opioids
  • Current clinical (DSM-5) opioid use disorder of any level of severity

Who cannot join

  • Unable to speak English
  • Unable to provide informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York University

    New York, New York, 10003

Other trials in United States

About this study

Official title: Evaluation of a Community-based Education, Navigation, and Support (CENS) Intervention to Reduce Opioid-related Harms Among Military Veterans

Military veterans in the U.S. represent one of the populations most disproportionately impacted by the current opioid crisis. Veterans who use opioids and are not connected to the VA healthcare system have high rates of homelessness and experience higher prevalence of comorbid substance use disorder and mental health diagnoses than their "service-connected" counterparts. Due to these vulnerabilities and the observed barriers to testing and treatment among veterans-especially substance- and mental health-related stigma, drug naiveté, and limited support networks-veterans who use opioids represent a critical target for interventions designed to mitigate overdose and HIV/HCV risk behaviors. For socially isolated veterans and veterans with limited access to healthcare, programs that work outside of formal healthcare institutions and agencies are desperately needed. This application proposes to achieve the following Aims: 1) Evaluate the effectiveness of a peer-delivered, community-based education, navigation and support (CENS) intervention to reduce opioid-related risk behaviors; 2) Examine factors that mediate (e.g., knowledge, self-efficacy, self-stigma) and moderate (e.g., mental health, pain/OUD severity, age) intervention effectiveness; and 3) Explore intervention participants' and peer outreach staff perspectives on implementation as well as barriers to and facilitators of intervention effectiveness. The proposed intervention will be delivered by veteran peer outreach workers. The study will recruit 300 veterans with opioid use disorder to participate in a randomized controlled trial. The CENS intervention will engage 150 participants in ongoing educational sessions, healthcare and treatment navigation, and social support (involving both one-on-one and group social integration protocols) designed to improve self-efficacy, reduce self-stigma, increase service and healthcare utilization, and bolster knowledge. This study stands to contribute a timely, culturally-tailored innovation to overdose and HIV/HCV prevention-as-usual that, informed by the theory of triadic influence, directly confronts the social, intrapersonal, and structural-level barriers to opioid-related risk reduction among veterans. Study findings will be of great interest to community-based and civic healthcare organizations that provide overdose and HIV/HCV risk reduction outreach, as well as to agencies committed to improving healthcare engagement among veterans.

Read the detailed description

The U.S. remains in a public health crisis involving opioid-related morbidity and mortality,1 and military veterans have been disproportionately impacted. Among veterans who use VA hospitals, the prevalence of OD deaths from non-synthetic opioids roughly doubled between 2001 and 2009, and deaths among this population have continued to rise dramatically, showing a 65 percent increase from 2010 to 2016 alone. This trend is grounded in high rates of concurrent prescription opioid (PO) and benzodiazepine use, but transitions from POs to heroin9 have been a recent driver of OD mortality and the disproportionately high HIV and HCV infection rates among veterans.1 Additionally, much of the scientific knowledge about health risks among veterans who use opioids (VWUO) comes from VA samples, which represent less than half of all military veterans. Veterans who do not have VA access or choose not to use it, include many of those most historically disadvantaged and at greatest risk of opioid-related harm. Rates of 'other than honorable' discharges for active duty personnel with alcohol or substance use issues have increased, excluding them from VA care and resulting in underestimates of opioid-related harms among the broader veteran population. For example, the prevalence of HCV infection-driven primarily by injection drug use-has been estimated at 11-18% among veterans who utilize the VA but up to 45% among the sizable population of homeless veterans, most of whom do not. Irrespective of benefit status, many veterans with substance and alcohol use disorders avoid substance use treatment, healthcare, and supported social services, such as opioid agonist therapy, housing and employment assistance, syringe service programs, mental health treatment, and HIV/HCV testing and treatment. Social isolation and a sense of alienation from civilian society have long represented important barriers to working with veteran populations and highlight the need for targeted, culturally sensitive interventions that reach at-risk veterans in community settings.

This application proposes to address this need by evaluating a community-based peer intervention for veterans with opioid use disorder that aims to reduce risk behaviors for opioid-related overdose and HIV/HCV infection. The use of peer-based outreach is designed to reach veteran subpopulations experiencing homelessness, mental health challenges, and significant barriers to healthcare access. Specifically, the intervention to be evaluated will overcome barriers at the three different levels underpinning the theory of triadic influence. Intrapersonal-level barriers for veterans include mental health problems (including PTSD, depression, suicidal ideation), chronic pain, low self-efficacy for behavior change and service involvement, competing priorities related to poverty and homelessness, and distrust of medical systems. Social/interpersonal-level barriers include social isolation, fears of treatment-related stigma (related to military culture), including concerns about the potential impact of seeking treatment on career progression and difficulties interacting with civilians. Last, sociocultural and structural-level barriers, include threats to future career progression represented by a mental health or OUD diagnosis and insufficient education to navigate complex health systems.

The intervention draws on the work of the study team and its experience implementing peer-delivered overdose prevention. This application presents a randomized control trial protocol for assessing a 9-month peer-based intervention employing dedicated veteran specialists to deliver each of the intervention components-education, healthcare/service navigation and social support. These components are all designed to facilitate decreased opioid-related HIV/HCV and OD risk behaviors at the end of the 9-month exposure. The study's specific aims are as follows:

Aim 1: Evaluate the effectiveness of a peer-delivered, community-based education, navigation and support (CENS) intervention to reduce opioid-related risk behaviors (OD/HIV/HCV). The team will use targeted, venue-based sampling to recruit a total of 300 veterans with opioid use disorder. Participants will be randomly assigned (150 each arm) to the 9-month CENS intervention or a 9-month standard naloxone-plus-referrals control and assessed at baseline and at 3-, 6- and 9-months post-baseline, then again at 15-months post-baseline to assess durability of effects. Effectiveness will be measured by treatment and supportive social service utilization and self-reported change in opioid OD52 and HIV/HCV57 risk behaviors.

Aim 2: Examine factors that mediate (e.g., knowledge, self-efficacy, self-stigma) and moderate (e.g., treatment experiences, pain and OUD severity, gender, age) intervention effectiveness.

Aim 3: Explore intervention participants' and peer outreach staff perspectives on implementation as well as barriers to and facilitators of intervention effectiveness. Using in-depth qualitative interviews with a subsample of participants (n=35), service providers (n=10) and peer staff interventionists (n=3), the team will assess participant experiences, psychosocial dynamics underlying intervention effectiveness, and barriers encountered. Findings will be used to inform future implementation and scale-up efforts.

This study stands to contribute a timely, culturally-tailored innovation to overdose prevention-as-usual that, informed by the theory of triadic influence, directly targets the social, intrapersonal, and structural-level barriers to opioid-related risk reduction among veterans. Study findings will be of great interest to community-based and civic healthcare organizations that provide overdose and HIV/HCV risk-reduction outreach, as well as to agencies committed to improving healthcare engagement among veterans.

Being tested
Overdose Education and Naloxone Distribution, Advanced Education in Safer Substance Use, Treatment, and Self-Care, Social Service and Health Navigation, Peer Social Support
Medical subject headings
Drug Overdose, Opioid-Related Disorders, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Overdose Education and Naloxone DistributionBehavioural

    Also called OEND

    Education on OD risk behaviors and methods for responding to an OD, including naloxone use.

    Duration and dose: Single 20-minute training at time of enrollment, provided to all participants in both arms

  • Advanced Education in Safer Substance Use, Treatment, and Self-CareBehavioural

    Also called Education

    Education about misinformation about OAT, self-care, SEP services, HIV/HCV treatment Duration/dose: 9 mos., monthly ~2 hr. group sessions + ongoing access to video archive of recorded trainings.

  • Social Service and Health NavigationBehavioural

    Also called Navigation

    Help navigate access and barriers to healthcare, motivation and health goals Duration/dose: 9 mos., monthly face-to-face sessions to set goals and schedule appts, phone calls between sessions > 1x/wk.

  • Peer Social SupportBehavioural

    Also called Support

    Support with social (re)integration, isolation, relationship building Duration/dose: 9 mos., monthly face-to-face events and phone calls/texts between sessions > 1x/wk.

Study groups in NCT05343169
Study groupRoleWhat they receive
CENS InterventionExperimentalPeer outreach workers will deliver Overdose Education and Naloxone to participants and provide education, navigation, and support during the 9-month intervention
Receives: Behavioral: Overdose Education and Naloxone Distribution; Behavioral: Advanced Education in Safer Substance Use, Treatment, and Self-Care; Behavioral: Social Service and Health Navigation; Behavioral: Peer Social Support
ControlOtherParticipants will receive Overdose Education and Naloxone and referrals to treatment
Receives: Behavioral: Overdose Education and Naloxone Distribution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Opioid Overdose Risk Behaviors Scale

    Change in Overdose Risk Behavior Scale score, from baseline to 9 months. Min Score= 0 Max Score = 660 Higher scores indicate more engagement in overdose risk behaviors

    Measured: 9 months follow-up assesment

  2. Change in HIV/HCV Risk Behaviors

    Change in HIV/HCV risk behaviors as measured by the National HIV Behavioral Surveillance System questions about unsafe sexual and injection risk, from baseline to 9 month follow up.

    Measured: 9 months follow-up assessment

Secondary outcomes (3)
  1. Health service utilization

    Utilization of services as measured by number of visits in past 3 months, e.g. VHA hospitals, syringe exchange, healthcare providers. Measured by the investigator-developed questionnaire.

    Measured: 9 months follow-up assessment

  2. Drug Treatment

    Utilization of drug treatment in the past 3-months Yes/No Response

    Measured: 9 months follow-up assessment

  3. HIV/HCV Testing

    Past 3-month number of antibody tests for HIV and HCV

    Measured: 9 months follow-up assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2022
  2. Study start21 Oct 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two arm, parallel randomized control trial
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05343169
Sponsor's protocol ID
R01DA052426
Acronym
CENS
Status last verified
Jun 2025
First submitted
8 Mar 2022
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared via openICPSR© Self-Deposit Package. All specific identifies will be removed from final datasets prior to release for sharing. To prevent the unlikely but possible deductive disclosure of participant identity with particular characteristics, the study team will make the data available to other investigators only after discussion and under a formal data-sharing agreement that provides for: (1) commitment to use data for research purposes only and not to identify individual study participants; (2) commitment to promote objectivity in research using these data by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH awards will be free from bias (3) commitment to use appropriate information technology systems to keep data secure; and (4) commitment to returning or destroying data after analyses are complete.

Questions about this trial

What is this clinical trial studying?

A study testing Overdose Education and Naloxone Distribution, Advanced Education in Safer Substance Use, Treatment, and Self-Care and Social Service and Health Navigation in people with Overdose and Opioid Use Disorder, run by New York University 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 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in Opioid Overdose Risk Behaviors Scale (time frame: 9 months follow-up assesment). The study lists 2 primary outcomes in all. 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 3 Jun 2026.

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