Apply to Trial

Compensation: Varies

Number of Visits: 2

Duration: 4 days for fasted condition, 8 days for fed condition

VK4-116 for Opioid Use Disorder

Overseen ByDebra Kelsh, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute on Drug Abuse (NIDA)

Must not be taking: Opioids, Benzodiazepines, others

Disqualifiers: Cardiac, Hepatic, Renal, Neurologic, others

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called VK4-116, developed for people with opioid use disorder. The main goal is to assess the treatment's safety, tolerability, and how the body processes it. Participants will receive different doses to compare effects, either with or without food, or a placebo (a harmless pill with no active drug). The trial seeks healthy individuals without significant medical conditions who do not use nicotine products. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking prescribed medications 14 days before the study and over-the-counter medications, supplements, or vitamins 7 days before the study.

Is there any evidence suggesting that VK4-116 is likely to be safe for humans?

Research has shown that VK4-116 demonstrates promising safety results in lab studies. These studies suggest that VK4-116 is safe in lab settings, which bodes well for its development as a treatment for opioid use disorder. However, since this clinical trial is in its earliest phase, it primarily focuses on assessing the safety of VK4-116 in humans. The trial aims to determine how well people tolerate the treatment and identify any side effects. Until the trial progresses, direct information on VK4-116's effects on people remains limited.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising for opioid use disorder?

Researchers are excited about VK4-116 for opioid use disorder because it offers a new approach compared to existing treatments like methadone or buprenorphine, which primarily work by acting on opioid receptors. VK4-116 is unique because it targets different pathways in the brain, potentially reducing cravings and withdrawal symptoms without relying on opioid receptor activity. This novel mechanism might provide an alternative for those who do not respond well to current medications. Additionally, VK4-116 is administered orally, which could make it a convenient option for patients.

What evidence suggests that VK4-116 might be an effective treatment for opioid use disorder?

Research has shown that VK4-116, a drug tested in this trial for opioid use disorder (OUD), can be effective. It blocks a specific brain receptor linked to addiction. Studies have found that VK4-116 reduced opioid use and eased withdrawal symptoms. It also improved behaviors like decision-making, often affected by drug use. Although most of this information comes from lab studies, these early results are promising for VK4-116 as a potential treatment for OUD.² ⁴ ⁶ ⁷ ⁸

Who Is on the Research Team?

Marta De Santis, PhD

Principal Investigator

National Institute on Drug Abuse, NIH

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who want to help test a new drug called VK4-116. It's not for people with opioid use disorder or addiction, but the results might one day help those who do.

Inclusion Criteria

I am following the required birth control guidelines.

Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures

Be able and willing to comply with protocol requirements and the rules and regulations of the study site, and be likely to complete all the study treatments

See 3 more

Exclusion Criteria

Use nicotine products via smoking/vaping in past 6 months

I have a history of heart conditions.

Have any clinically significant finding within one year of Screening that contraindicates participation in the study

See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a single ascending dose of VK4-116 or placebo and are monitored for safety, tolerability, and pharmacokinetics

4 days for fasted condition, 8 days for fed condition

Continuous monitoring during clinic stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

VK4-116

Trial Overview

VK4-116 is being tested in this study. Volunteers will take different doses of the drug or a placebo without knowing which they're getting. The study looks at how safe it is and how the body processes it when taken with and without food.

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Placebo Group

Group I: 500 mg doseExperimental Treatment1 Intervention