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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Advanced Education in Safer Substance Use, Treatment, and Self-Care, Overdose Education and Naloxone Distribution, OEND, Naloxone Distribution Program, Peer Social Support, Peer Social Support, Community-based Education, Navigation, and Support Intervention, Peer-delivered Intervention, Social Service and Health Navigation?

Research shows that overdose education and naloxone distribution programs can effectively increase people's ability to prevent and respond to opioid overdoses, with some programs reporting successful overdose reversals. Additionally, these programs can boost confidence in handling overdose situations, which can last for up to a year after training. ^{1 2 3 4 5}

Is the Community Support & Education for Opioid Use Disorder treatment safe for humans?

The safety of programs like Community Support & Education for Opioid Use Disorder, which include overdose education and naloxone distribution, is generally supported by research. These programs are designed to educate people on how to prevent and respond to opioid overdoses, and they have been shown to increase confidence in handling such situations without reported safety concerns. ^{1 2 4 5 6}

How is the Community Support & Education for Opioid Use Disorder treatment different from other treatments?

This treatment is unique because it combines education on safer substance use, overdose prevention, and naloxone distribution with peer social support and navigation of social and health services, offering a comprehensive community-based approach rather than focusing solely on medication or individual therapy. ^{1 4 5 6 7}

Research Team

Alexander S Bennett, PhD

Principal Investigator

New York University

Eligibility Criteria

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

I am 18 years old or older.

Current nonmedical use of opioids

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

Exclusion Criteria

Unable to provide informed consent.

I cannot speak English.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Ireland 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. [2022]

2. England 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. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Overdose Education and Naloxone Distribution Program of the Baltimore Student Harm Reduction Coalition. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Opioid overdose and naloxone education in a substance use disorder treatment program. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Overdose education and naloxone distribution program design informed by people who use drugs and naloxone distributors. [2023]

7. Ireland 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. [2022]