What side effects are associated with this type of intervention?

Methadone and buprenorphine are common treatments in Opiate Substitution Therapy. Methadone can cause side effects such as constipation, drowsiness, sweating, peripheral edema, and potential for QT interval prolongation, which can lead to serious heart arrhythmias. Buprenorphine's side effects include headache, nausea, constipation, and sweating. Both medications carry a risk of dependency and should be used under medical supervision to manage these risks effectively.

What prior FDA approvals exist?

The FDA has approved several medications for Opiate Substitution Therapy, including methadone, buprenorphine, and naltrexone. Methadone is a long-acting opioid agonist used for decades in substitution therapy. Buprenorphine, a partial opioid agonist, is available in sublingual tablets and films and effectively reduces opioid use. Naltrexone, an opioid antagonist, is available in oral and extended-release injectable forms and helps prevent relapse. These treatments align with harm reduction strategies, such as those studied in the Harm Reduction Kiosk trial, which aims to reduce risk behaviors associated with drug use.

What other types of research exist?

Promising, novel alternatives to Harm Reduction Kiosks for Opiate Substitution Therapy patients include: 1) Telehealth services for remote counseling and support, 2) Mobile health units providing on-site medical care and resources, 3) Digital platforms and apps for personalized treatment plans and monitoring, 4) Community-based peer support programs, and 5) Integrated care models combining primary care, mental health services, and addiction treatment in one setting.

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Harm Reduction Kiosk for Substance Use-Related Health Risks

N/A

Waitlist Available

Led By April M Young, PhD

Research Sponsored by April M Young

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline and then every 6 months up to 5 years

Awards & highlights

Summary

This trial will test a new harm reduction kiosk called KyOSK in rural Appalachia to help people who use drugs stay safer. The kiosk provides clean needles and other supplies to reduce the risk of HIV, hepatitis C, and overdoses. The study aims to determine if this new approach is more effective and cost-efficient.

Who is the study for?

This trial is for adults over 18 living in specific Kentucky counties who've used drugs (other than marijuana, alcohol, and tobacco) to get high via injection or other methods in the past 6 months. It's not open to those under 18 or outside these areas.

What is being tested?

The study is examining if a harm reduction kiosk can lower risks of HIV, hepatitis C, and drug overdoses among drug users in rural Appalachia. The effectiveness and cost will be evaluated by comparing two counties.

What are the potential side effects?

Since this trial involves using a service (harm reduction kiosk) rather than a medical intervention like medication or surgery, traditional side effects are not applicable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and then every 6 months up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline and then every 6 months up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and then every 6 months up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in SSP / KyOSK-provided syringe coverage for injections

Change in harm reduction program supplied syringe coverage for injections

Change in syringe coverage for injections

Secondary study objectives

Change in frequency of condom-less anal and/or vaginal sex

Change in frequency of distributive syringe sharing among participants who inject drugs

Change in frequency of engagement in overdose protective behaviors among participants who use drugs

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Syringe Service Program Plus a Harm Reduction Kiosk InterventionExperimental Treatment1 Intervention

The intervention to be implemented in the intervention county involves enhancing its existing SSP model with a KyOSK. The intervention county SSP operates identically to the comparison county. As in the comparison county, a card reader will be installed in the intervention county SSP at the beginning of the study to provide objective data on visits and supply access. The KyOSK will resemble a vending machine. The KyOSK will include harm reduction, wound care, hygiene, and other supplies; offer overdose education and other content; a sharps container with a device to obtain data on syringe disposal; and an innovative call-back feature for care navigation by recovery coaches. While the KyOSK is operating, the intervention county will operate its traditional SSP 40 hours/week.

Group II: Syringe Service ProgramActive Control1 Intervention

The comparison county SSP operates in the local health department and provides syringes, cookers/cottons, naloxone, wound care kits, condoms and lubricant, snacks, drinks, and sharps containers. A peer support specialist is present for consultation with clients upon request during SSP hours. The SSP will expand it hours from 3 hours/week to 40 hours/week at the same time the intervention county receives its KyOSK, to be comparable. SSP clients who enroll in the study will receive a swipe card linked to their SSP client identification. Card readers will be installed in the SSP for clients to swipe upon entry. Staff will provide clients with the same menu of supplies as those in the KyOSK and the same supply/time interval limits will be imposed. SSP clients will receive a resource guide.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Opiate Substitution Therapy (OST) include methadone, buprenorphine, and naltrexone. Methadone, a full opioid agonist, activates opioid receptors to alleviate withdrawal symptoms and reduce cravings. Buprenorphine, a partial opioid agonist, activates these receptors to a lesser extent, minimizing the risk of misuse and overdose. Naltrexone, an opioid antagonist, blocks opioid receptors to prevent the euphoric effects of opioids, aiding in maintaining abstinence. These mechanisms are crucial for OST patients as they help stabilize their condition, reduce relapse risk, and improve treatment adherence. The Harm Reduction Kiosk study supports these treatments by providing resources and education to mitigate risk behaviors associated with drug use.

Effect of prison-based opioid substitution treatment and post-release retention in treatment on risk of re-incarceration.

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Who is running the clinical trial?

April M YoungLead Sponsor

1 Previous Clinical Trials

234 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,543 Previous Clinical Trials

3,248,624 Total Patients Enrolled

152 Trials studying Substance Abuse

706,448 Patients Enrolled for Substance Abuse

April M Young, PhDPrincipal InvestigatorUniversity of Kentucky

Media Library

Harm reduction kiosk Clinical Trial Eligibility Overview. Trial Name: NCT05657106 — N/A

Substance Abuse Research Study Groups: Syringe Service Program Plus a Harm Reduction Kiosk Intervention, Syringe Service Program

Substance Abuse Clinical Trial 2023: Harm reduction kiosk Highlights & Side Effects. Trial Name: NCT05657106 — N/A

Harm reduction kiosk 2023 Treatment Timeline for Medical Study. Trial Name: NCT05657106 — N/A

~414 spots leftby Jul 2026

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