Overdose Prevention Intervention for Drug Overdose

(Oasis Trial)

Overseen by Carl Latkin, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Mental, physical impairments, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this drug for overdose prevention?

Research shows that naloxone, a drug used to reverse opioid overdoses, can reduce overdose deaths when prescribed by HIV clinicians. Additionally, buprenorphine, a medication for opioid use disorder, is effective in reducing opioid cravings and overdoses, especially when integrated into HIV care. ^{1 2 3 4 5}

Is naloxone safe for use in preventing opioid overdose?

Naloxone has a long history of safe use in treating opioid overdoses, with serious adverse reactions being rare. It is generally safe when used by healthcare professionals, and community programs have successfully trained non-professionals to use it safely in emergency situations. ^{6 7 8 9 10}

How is this drug different from other overdose prevention drugs?

This treatment is unique because it combines HIV prevention, Hepatitis C treatment, and opioid overdose prevention using naloxone, which is a specific drug that can quickly reverse opioid overdoses by counteracting the effects of opioids on the brain. ^{8 9 11 12 13}

Research Team

Carl Latkin, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

This trial is for current opioid users who have used within the last two weeks. It's aimed at people who inject drugs and are at risk of HIV, hepatitis C, or drug overdose. Participants must be able to engage in the study without mental or physical health issues interfering.

Inclusion Criteria

Current drug user (opioid use in the prior two weeks)

Exclusion Criteria

I do not have any health issues that prevent me from participating.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive peer education and risk reduction materials in semi-public injection settings

6 months

6 sessions (in-person)

Follow-up

Participants are monitored for changes in overdose and HIV/HCV prevention behaviors

6 months

Treatment Details

Interventions

• HIV, HCV and overdose prevention (Behavioral Intervention)

Trial Overview The study tests a new peer-driven intervention designed to reduce the risks of HIV, hepatitis C virus transmission, and overdoses among those who inject drugs. It's a pilot program focusing on injection settings.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

behavioral training with 6 sessions

Group II: comparison Active Control 1 Intervention

Attention control

HIV, HCV and overdose prevention is already approved in Canada, Japan, Switzerland for the following indications:

Approved in Canada as HIV PrEP, HCV Treatment, MAT, Naloxone for:

• HIV prevention
• HCV treatment
• Opioid use disorder treatment
• Opioid overdose reversal

Approved in Japan as HIV PrEP, HCV Treatment, MAT, Naloxone for:

• HIV prevention
• HCV treatment
• Opioid use disorder treatment
• Opioid overdose reversal

Approved in Switzerland as HIV PrEP, HCV Treatment, MAT, Naloxone for:

• HIV prevention
• HCV treatment
• Opioid use disorder treatment
• Opioid overdose reversal

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Dr. Joshua M. Sharfstein

Johns Hopkins Bloomberg School of Public Health

Chief Medical Officer since 2015

MD from Johns Hopkins University

Dr. Ellen J. MacKenzie

Johns Hopkins Bloomberg School of Public Health

Chief Executive Officer since 2017

MD from Johns Hopkins University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

In a study of people with HIV on chronic opioid therapy, receiving naloxone rescue kits was found to be uncommon, highlighting a gap in overdose prevention measures.

While a history of overdose increased the likelihood of receiving naloxone, the presence of clinicians providing overdose prevention care did not significantly impact naloxone co-prescribing, suggesting a need for improved practices among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naloxone receipt and overdose prevention care among people with HIV on chronic opioid therapy. Kimmel, SD., Walley, AY., Lodi, S., et al.[2023]

A pilot program for overdose education and naloxone distribution (OEND) in a Philadelphia jail showed that it is feasible and effective, with significant improvements in overdose knowledge and attitudes among 68 participants who were still incarcerated one month later.

The program specifically targeted people living with HIV (PLWH) and demonstrated that OEND can be beneficial for vulnerable populations in correctional settings, suggesting it should be expanded to include other at-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in overdose knowledge and attitudes in an incarcerated sample of people living with HIV. Reed, M., Siegler, A., Tabb, LP., et al.[2023]

A study involving 122 HIV clinicians showed that on-site peer-to-peer training significantly increased their likelihood to prescribe naloxone, with an odds ratio of 4.1, indicating a strong positive change in attitudes towards naloxone prescribing.

The intervention led to a notable increase in the number of clinicians prescribing naloxone across 18 out of 22 sites, with a 2.9 times higher incidence rate of naloxone prescriptions post-intervention, although the overall percentage of HIV patients receiving naloxone only modestly increased from 0.97% to 1.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribe to Save Lives: An Intervention to Increase Naloxone Prescribing Among HIV Clinicians. Friedmann, PD., Jawa, R., Wilson, D., et al.[2023]

The M2HepPrEP trial aims to evaluate the effectiveness of an integrated care model for providing HIV pre-exposure prophylaxis (PrEP) and hepatitis C virus (HCV) treatment directly at syringe service and opioid agonist therapy programs, involving 500 participants who have injected drugs in the past 6 months.

This study will compare on-site care with patient navigation to off-site clinics, focusing on adherence to PrEP and HCV treatment outcomes, potentially demonstrating a more effective approach to addressing these co-occurring health issues among people who inject drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID. Martel-Laferrière, V., Feaster, DJ., Metsch, LR., et al.[2022]

Buprenorphine is a safe and effective medication for treating opioid use disorder (OUD) in individuals with HIV, helping to reduce cravings and overdose risks while improving HIV care outcomes.

Despite its proven benefits, there is a significant gap in the implementation of buprenorphine prescribing in HIV care settings, highlighting the need for HIV clinicians to obtain waivers and integrate OUD education into their training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Call to Action: Integration of Buprenorphine Prescribing Into the Care of Persons With Human Immunodeficiency Virus and Opioid Use Disorder. Fujita, AW., Wilson, JD., Kennedy, AJ.[2022]

Naloxone is a safe and effective antidote for opioid overdose, with a long history of use by healthcare professionals, and expanding access to it for high-risk individuals and their families is a key public health initiative.

While naloxone is generally safe, its administration can lead to varying levels of adverse reactions, especially with higher doses or intravenous use, highlighting the importance of training for non-healthcare professionals in recognizing overdoses and administering naloxone correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access. Wermeling, DP.[2020]

In a study of 204 HIV-negative patients at a substance use disorder bridge clinic, 27% were eligible for HIV prevention methods (PEP and PrEP), indicating a significant need for these services among people who inject drugs (PWID).

While most eligible patients were offered PEP or PrEP, only a small percentage (14.6%) of those eligible for PrEP were actually prescribed it, highlighting the need for further investigation into barriers to accessing these critical HIV prevention treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Exposure Prophylaxis Delivery in a Low-barrier Substance Use Disorder Bridge Clinic during a Local HIV Outbreak at the Onset of the COVID-19 Pandemic. Braun, HM., Walter, C., Farrell, N., et al.[2023]

The DOPE Project trained 1,942 individuals in San Francisco to use naloxone, with 11% reporting they used it during an overdose event, demonstrating a willingness among injection drug users to learn and apply overdose response strategies.

Naloxone was highly effective, with 89% of overdose events reversed when naloxone was administered, and fewer than 1% of participants reported serious adverse effects, highlighting its safety and efficacy as a life-saving intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdose prevention and naloxone prescription for opioid users in San Francisco. Enteen, L., Bauer, J., McLean, R., et al.[2021]

Since 1996, community-based programs have trained over 53,000 individuals and distributed naloxone, leading to 10,171 reported reversals of opioid overdoses, highlighting the efficacy of naloxone in preventing fatal outcomes from opioid overdoses.

Naloxone is specifically effective for reversing opioid overdoses, but it does not work on non-opioid overdoses, emphasizing the need for targeted education and distribution of naloxone among those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based opioid overdose prevention programs providing naloxone - United States, 2010. [2022]

The iRaPID program, which provides same-day access to HIV prevention (PrEP) and medications for opioid use disorder (MOUD), is being pilot tested to assess its feasibility and acceptability among people who inject drugs, with 50 participants enrolled in the study.

This innovative approach aims to reduce barriers to accessing critical health services, potentially improving uptake of both PrEP and MOUD, which is essential in addressing the dual challenges of opioid use and HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse Practitioner-Led Integrated Rapid Access to HIV Prevention for People Who Inject Drugs (iRaPID): Protocol for a Pilot Randomized Controlled Trial. Khati, A., Altice, FL., Vlahov, D., et al.[2023]

Heroin overdoses have become more common, with risk factors including recent abstinence and polydrug use, highlighting the urgent need for effective prevention strategies.

Naloxone is a safe and effective treatment for reversing heroin overdose effects, as it quickly counteracts respiratory depression and sedation, making it a crucial tool for overdose prevention in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription naloxone: a novel approach to heroin overdose prevention. Sporer, KA., Kral, AH.[2022]

A performance improvement project involving 47 opioid-dependent inpatients and their families showed that overdose prevention training significantly increased their ability to recognize an opioid overdose and their comfort in assisting during an overdose situation.

Despite 32% of family members being aware of a prior overdose, the training highlighted the importance of naloxone education and harm reduction strategies, suggesting that such programs are beneficial and should be integrated into residential treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid overdose prevention in a residential care setting: Naloxone education and distribution. Pade, P., Fehling, P., Collins, S., et al.[2018]

In a study of 46,846 individuals with opioid use disorder, buprenorphine treatment significantly reduced the risk of opioid-related overdose compared to no treatment, with an adjusted hazard ratio of 0.40.

In contrast, both extended-release injectable and oral naltrexone did not show a significant reduction in overdose risk, indicating that buprenorphine may be a more effective option for preventing overdoses in patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdose following initiation of naltrexone and buprenorphine medication treatment for opioid use disorder in a United States commercially insured cohort. Morgan, JR., Schackman, BR., Weinstein, ZM., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Naloxone receipt and overdose prevention care among people with HIV on chronic opioid therapy. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Changes in overdose knowledge and attitudes in an incarcerated sample of people living with HIV. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Prescribe to Save Lives: An Intervention to Increase Naloxone Prescribing Among HIV Clinicians. [2023]

4. England pubmed.ncbi.nlm.nih.gov

M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID. [2022]

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

A Call to Action: Integration of Buprenorphine Prescribing Into the Care of Persons With Human Immunodeficiency Virus and Opioid Use Disorder. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

HIV Exposure Prophylaxis Delivery in a Low-barrier Substance Use Disorder Bridge Clinic during a Local HIV Outbreak at the Onset of the COVID-19 Pandemic. [2023]

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

Overdose prevention and naloxone prescription for opioid users in San Francisco. [2021]

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

Community-based opioid overdose prevention programs providing naloxone - United States, 2010. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Nurse Practitioner-Led Integrated Rapid Access to HIV Prevention for People Who Inject Drugs (iRaPID): Protocol for a Pilot Randomized Controlled Trial. [2023]

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

Prescription naloxone: a novel approach to heroin overdose prevention. [2022]

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

Opioid overdose prevention in a residential care setting: Naloxone education and distribution. [2018]

13. Ireland pubmed.ncbi.nlm.nih.gov

Overdose following initiation of naltrexone and buprenorphine medication treatment for opioid use disorder in a United States commercially insured cohort. [2022]