Overdose Prevention for Substance Use Disorder and Homelessness

(HOPE Trial)

AM
MC
Overseen ByMadeleine C Golding, MPH BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to prevent overdoses among homeless Veterans with substance use disorders. It emphasizes education on overdose prevention and the distribution of naloxone, a medication that can reverse an overdose. The trial compares two approaches: a low-intensity version, offering resources and guidance, and a high-intensity version, providing more hands-on support and training. Veterans in a supportive housing program who are at risk for opioid overdose may be suitable candidates for this trial. As an unphased trial, it offers Veterans the opportunity to contribute to innovative solutions for overdose prevention.

What prior data suggests that this overdose prevention program is safe for homeless Veterans?

A previous study showed that overdose education and naloxone distribution (OEND) are safe. Naloxone, a medication that can reverse opioid overdoses, has been used safely for years. Research shows that OEND programs are generally well-tolerated by participants, with few reported side effects. These programs aim to teach people about overdose risks and provide naloxone.

The Homeless Overdose Prevention-Expansion (HOPE) treatment includes both High Intensity and Low Intensity approaches, focusing on education and naloxone distribution. This builds on existing evidence that these strategies are safe and effective for helping those at risk of overdose.

Both HOPE approaches rely on methods known to be safe. No new medication is being tested, so the risk of side effects remains low. The focus is on providing education and resources to prevent overdoses, a strategy safely used in similar settings.12345

Why are researchers excited about this trial?

Researchers are excited about the HOPE program because it aims to address overdose prevention in a unique way for people experiencing homelessness. Unlike traditional approaches that often focus solely on medication-assisted treatment or naloxone distribution, HOPE combines structured training and resources with different intensity levels of support. The high-intensity approach stands out by integrating a dedicated clinical team and providing regular feedback and technical assistance, which could enhance the effectiveness of overdose education and prevention strategies. This adaptability and focus on comprehensive support could lead to more successful outcomes in preventing overdoses among this vulnerable population.

What evidence suggests that this trial's treatments could be effective for overdose prevention in homeless Veterans?

Research has shown that programs teaching overdose prevention and providing naloxone can reduce overdose deaths. These programs equip people with crucial knowledge and tools to save lives. Naloxone, a medication that can reverse opioid overdoses if administered quickly, plays a key role. This trial will compare two approaches within the Homeless Overdose Prevention-Expansion (HOPE) program, specifically designed for homeless veterans. Participants will be assigned to either the high-intensity or low-intensity HOPE program. Although direct data on these specific programs is limited, their core methods, such as overdose education and naloxone distribution, have a strong track record of success.

Who Is on the Research Team?

AM

Amanda M. Midboe, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for Veterans who are homeless or in supportive housing, enrolled in the HUD-VASH program, and at risk for opioid overdose based on specific VA data. Participants must be patients at a site taking part in this study.

Inclusion Criteria

Veterans enrolled in HUD-VASH at risk for opioid overdose based on existing HOPE algorithms aligned with Pharmacy Benefit Manager data definitions, drawing from VA administrative data.

Exclusion Criteria

Not flagged by existing HOPE algorithms
Not currently enrolled in HUD-VASH
Is not a patient at a participating site of the implementation trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Low-Intensity Implementation

The LI implementation approach includes providing sites with the HOPE Implementation Playbook and leading a monthly learning collaborative for 6 months.

6 months
Monthly learning collaborative sessions

High-Intensity Implementation

The HI approach includes creation of a novel clinical team, monthly overdose education and training, monthly audit and feedback, and technical assistance.

6 months
Monthly training and feedback sessions

Follow-up

Participants are monitored for the maintenance of OEND as part of routine organizational practices and policies.

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Homeless Overdose Prevention- Expansion (HOPE) - High Intensity
  • Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity

Trial Overview

The study compares two levels of support (low vs. high intensity) for an overdose education and naloxone distribution program called HOPE, aimed at helping homeless-experienced Veterans avoid opioid overdoses.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Low-Intensity (LI)Active Control1 Intervention
Group II: High-Intensity (HI)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Article 4: Human Development and Substance Use Disorder

o 60% of the individuals experiencing homelessness developed mental health disorders and substance addiction as their situation worsened. Even though ...

UVicSPACE: Research & Learning Repository

The results are intended to provide practical knowledge and insights to inform shelter based strategies to mitigate the risks associated with substance use, ...

UVicSPACE: Research & Learning Repository

The results are intended to provide practical knowledge and insights to inform shelter based strategies to mitigate the risks associated with substance use, ...

Substance Abuse and Homelessness

Research consistently shows a high prevalence of substance abuse among individuals experiencing homelessness. Substance abuse can involve various substances, ...

Substance Abuse and Homelessness Correlation

Prevalence of Substance Abuse: Studies consistently show a high prevalence of substance abuse among individuals experiencing homelessness.