Community Support & Education for Opioid Use Disorder

(CENS Trial)

Overseen By Alexander S Bennett, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Unable to speak English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 9 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist veterans with opioid use disorder by providing community support and education outside traditional healthcare settings. The focus is on reducing risky opioid-related behaviors and improving healthcare access through peer-led education and support. Veterans will either receive ongoing peer support in educational sessions and social support or receive overdose education plus naloxone (a medication that can reverse an opioid overdose) with treatment referrals. Veterans who currently use opioids and do not receive medical care for it might be suitable candidates for this trial. As an unphased trial, this study offers veterans a unique opportunity to access innovative support and education tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this intervention is safe for veterans with opioid use disorder?

Research has shown that programs teaching about overdoses and providing naloxone are generally safe and effective. One study found that these programs increased understanding of opioid overdoses and improved attitudes towards prevention. Another report showed that people trained to use naloxone successfully revived individuals in 90% of overdose cases they encountered. This indicates that the program is not only safe but also very effective in real-life situations.

Peer support, another part of the trial treatment, also appears safe and effective. Studies have shown that peer support can help people with opioid use disorder (OUD) enter treatment and may lower overdose rates. One model predicted a decrease in both nonfatal and fatal overdoses among those receiving peer support.

Both components—overdose education with naloxone and peer support—have been well-received in past studies. They provide a solid approach to helping those with OUD, especially veterans in this context. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for opioid use disorder because they focus on a comprehensive approach that combines education, peer support, and resource navigation. Unlike standard options that primarily rely on medication-assisted treatment, this approach emphasizes community-based support, empowering individuals with knowledge about safer substance use and overdose prevention. By integrating peer outreach workers and connecting participants to social services, this method aims to address the broader social and health needs of individuals, potentially leading to more sustainable recovery outcomes.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Studies have shown that programs teaching about overdose and providing naloxone, a medication that can reverse an overdose, greatly improve understanding and attitudes about opioid overdoses. Research indicates that these programs enable quick responses in overdose situations, with reports showing individuals successfully revived overdose victims in 90% of cases. Additionally, these programs have been linked to increased long-term awareness and readiness to act in emergencies. In this trial, the CENS intervention arm includes these programs and offers education, support, and guidance to boost confidence and reduce feelings of shame. These efforts aim to empower veterans to make safer choices and use healthcare services more effectively. ^{1 2 4 5 6}

Who Is on the Research Team?

Alexander S Bennett, PhD

Principal Investigator

New York University

Are You a Good Fit for This Trial?

This trial is for adult veterans with any severity of opioid use disorder who currently misuse opioids and are not connected to VA healthcare. Participants must be able to speak English and provide informed consent.

Inclusion Criteria

Current nonmedical use of opioids

Current clinical (DSM-5) opioid use disorder of any level of severity

Veteran status

Exclusion Criteria

Unable to provide informed consent.

I cannot speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 9-month peer-delivered, community-based education, navigation, and support intervention to reduce opioid-related risk behaviors

9 months

Baseline, 3-month, 6-month, and 9-month assessments

Follow-up

Participants are monitored for the durability of intervention effects, including changes in opioid overdose and HIV/HCV risk behaviors

6 months

15-month post-baseline assessment

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Education in Safer Substance Use, Treatment, and Self-Care
• Overdose Education and Naloxone Distribution
• Peer Social Support
• Social Service and Health Navigation

Trial Overview The study tests a peer-delivered, community-based education, navigation, and support intervention aimed at reducing opioid-related risks among veterans. It includes overdose education, safer substance use knowledge, treatment guidance, social service navigation, and peer support.

How Is the Trial Designed?

Group I: Control Experimental Treatment 1 Intervention

Participants will receive Overdose Education and Naloxone and referrals to treatment

Group II: CENS Intervention Experimental Treatment 4 Interventions

Peer outreach workers will deliver Overdose Education and Naloxone to participants and provide education, navigation, and support during the 9-month intervention

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Published Research Related to This Trial

Overdose Education (OE) significantly improved knowledge about opioid overdose risks and naloxone use among 43 opioid users in a community treatment program, with knowledge gains maintained at a 3-month follow-up.

Despite the increase in overdose knowledge, the actual acquisition of naloxone was low, indicating that while education is beneficial, additional strategies may be needed to ensure naloxone access among individuals in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid overdose and naloxone education in a substance use disorder treatment program. Lott, DC., Rhodes, J.[2018]

People who use drugs (PWUD) and community naloxone distributors believe that overdose education and naloxone distribution (OEND) programs should be designed with input from PWUD to better address their specific needs and risk environments.

Participants emphasized the importance of peer-based naloxone distribution and integrating naloxone access into community organizations, highlighting that naloxone should be widely available and accessible within the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdose education and naloxone distribution program design informed by people who use drugs and naloxone distributors. Enich, M., Flumo, R., Campos, S., et al.[2023]

The study involved 13 codesign workshops over 9 months with stakeholders, including opioid users and healthcare providers, to develop a take-home naloxone (THN) kit aimed at improving responses to opioid overdoses.

The final THN kit prototype integrates ultra-brief training and nasal naloxone packaging, designed for distribution in various healthcare and community settings, addressing gaps in existing overdose education and emphasizing timely response and stigma reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design details for overdose education and take-home naloxone kits: Codesign with family medicine, emergency department, addictions medicine and community. Sellen, K., Goso, N., Halleran, L., et al.[2022]

The personally-tailored opioid overdose prevention education and naloxone distribution (PTOEND) intervention significantly increased participants' knowledge about overdose and medication for opioid use disorder (MOUD), while also decreasing perceived barriers to treatment.

Participants reported a significant reduction in opioid use and overdose-risk behaviors, with 65% utilizing naloxone, indicating that PTOEND effectively promotes harm reduction and readiness for treatment among illicit opioid users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids. Winhusen, T., Wilder, C., Lyons, MS., et al.[2022]

A 20-minute telephone-delivered peer recovery support service (PRSS) intervention led to a higher enrollment in medication for opioid use disorder (MOUD) among participants, with 32.5% of PRSS participants enrolling compared to 17.5% in the control group.

Participants receiving PRSS were significantly less likely to experience an opioid overdose (OOD) within 12 months, with only 12.5% reporting an OOD compared to 32.5% in the control group, indicating the potential effectiveness of PRSS in enhancing safety for individuals with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial. Winhusen, T., Wilder, C., Kropp, F., et al.[2022]

The Baltimore Student Harm Reduction Coalition (BSHRC) successfully distributed 250 free naloxone kits during an 8-month pilot program, demonstrating the feasibility of third-party naloxone prescriptions under new Maryland laws.

Training participants reported increased confidence in their ability to prevent and respond to overdoses, with this self-efficacy lasting for up to 12 months after the training, highlighting the program's potential for long-term impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Overdose Education and Naloxone Distribution Program of the Baltimore Student Harm Reduction Coalition. Lewis, DA., Park, JN., Vail, L., et al.[2022]

Online opioid overdose education significantly improved knowledge about overdose signs and naloxone administration, with average scores increasing from 6.82 to 8.22 out of 9 after training.

Participants who received a naloxone kit had significantly higher possession rates compared to those who only received instructions on obtaining a kit, highlighting barriers to accessing naloxone through pharmacies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use. Sisson, ML., Azuero, A., Chichester, KR., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489614/

The Effect of Overdose Education and Naloxone Distribution Our results suggest that there is credible evidence that OEND programs produce long-term knowledge improvements regarding opioid overdose, improve attitudes ...

2. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-22210-8

Effectiveness of naloxone distribution in community settings to ... We conducted a systematic literature review and meta-analysis to assess the effectiveness of overdose education and naloxone distribution (OEND) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772724625000241

Reported outcomes from a community naloxone training ... Individuals who helped with an overdose were able to revive the person in 172 (90 %) of the reported overdoses. Our data suggests that participants in these ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10480625/

Overdose education and naloxone distribution program ... This study aimed to understand the perspectives of PWUD and community naloxone distributors on OEND program design.

5. ajph.aphapublications.org ajph.aphapublications.org/doi/10.2105/AJPH.2024.307893

Overdose Education and Naloxone Distribution: An Evidence ... OEND as an evidence-based practice refers to three very specific models: (1) naloxone distribution directly to people who use drugs (PWUD) via ...

6. ajph.aphapublications.org ajph.aphapublications.org/doi/10.2105/AJPH.2024.307845

A Cluster-Randomized, Wait-List Controlled Trial | AJPH Overdose education and naloxone distribution, an EBP that decreases opioid-related overdose deaths, is a harm-reduction strategy that was ...