Naltrexone Implant for Opioid Use Disorder

Overseen By Eva Kemper, MSHS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Drug Delivery Company, LLC DBA Akyso Pharmaceuticals

Must not be taking: Anticoagulants, Prescription drugs, Methadone, others

Disqualifiers: Hypertension, Heart disease, Liver disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implant containing naltrexone to evaluate its safety and the drug's blood levels over three months. Naltrexone aids individuals struggling with opioid addiction. The study includes two groups: one receives the active naltrexone implant (BIOPIN-6 Naltrexone Implant), and the other receives a placebo (a harmless substance for comparison). Healthy men and women who do not smoke, are not taking certain medications, and can undergo a small surgical procedure are suitable candidates for this trial. As a Phase 1 trial, this 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 any prescription medications 14 days before the study and any over-the-counter medications, supplements, or vitamins 7 days before the study.

What prior data suggests that the BIOPIN-6 Naltrexone Implant is safe?

Research has shown that naltrexone implants, such as the BIOPIN-6, usually present few or manageable safety concerns, meaning most people don't experience serious side effects. Past studies tested these implants for opioid dependence, yielding promising results.

In animal studies, the BIOPIN naltrexone implant effectively managed symptoms without major problems. Although animal studies don't always exactly predict human outcomes, they still provide valuable insights.

Since this trial is in its early phase, it primarily focuses on assessing safety and how well the body handles the implant. If major safety issues existed, the trial likely wouldn't have progressed.

Overall, existing research suggests that the naltrexone implant is well-tolerated with few serious side effects. However, this trial aims to confirm these findings in healthy volunteers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the BIOPIN-6 Naltrexone Implant for opioid use disorder because it offers a novel delivery method that could change the game. Unlike standard treatments like oral naltrexone or methadone, which require daily doses, the BIOPIN-6 implant is a long-lasting option, placed under the skin in the abdominal area. This means it can continuously release medication over time, reducing the risk of missed doses and improving adherence. Additionally, the implant uses a combination of poly-d-l Lactic Acid and polycaprolactone to create a sustained-release system, which is a significant step forward in ensuring consistent therapeutic levels of the drug.

What evidence suggests that the BIOPIN-6 Naltrexone Implant might be an effective treatment for opioid use disorder?

This trial will compare the BIOPIN-6 active naltrexone implant with a placebo implant. Studies have shown that naltrexone implants can aid individuals with opioid use disorder by releasing naltrexone slowly over time, helping them stay off opioids and adhere to treatment plans. Research indicates that the BIOPIN-6 naltrexone implant is designed to maintain effective drug levels in the body for 6 to 12 months with just one dose. In studies with dogs, similar implants effectively reduced the effects of opioids. Although less data exists for humans, these findings suggest that the BIOPIN-6 implant could be a promising option for managing opioid use disorder. ^{1 2 3 4 6}

Who Is on the Research Team?

Todd Bertoch, MD

Principal Investigator

Cenexel JBR

Are You a Good Fit for This Trial?

Healthy adults aged 18-55, with a BMI of 18-32 and weighing at least 50 kg. Participants must not have HIV, Hepatitis B/C, or Covid and agree to use effective contraception methods if they become sexually active during the study.

Inclusion Criteria

I haven't used tobacco or nicotine products in the last 3 months.

Does not have a known hypersensitivity to local anesthesia

Does not have a known hypersensitivity to naltrexone

Exclusion Criteria

Has a known hypersensitivity to local anesthesia

Has had a naltrexone implant in the past 24 months

I have abnormal skin in the area where a medical device might be placed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BIOPIN-6 implant, which is left in place for 3 months

12 weeks

Implant insertion on Day 0

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Implant removal and final assessment

What Are the Treatments Tested in This Trial?

Interventions

• BIOPIN-6 Naltrexone Implant

Trial Overview The trial is testing a BIOPIN-6 implant that releases naltrexone into the body over three months. It's compared against a placebo implant. The goal is to check safety and how the body handles the drug.

How Is the Trial Designed?

Group I: BIOPIN-6 active implant Experimental Treatment 1 Intervention

Two sequential cohorts receiving 4.8 or 9.6 BIOPIN 6 implanted into a subcutaneous pocket in the upper abdominal wall.

Group II: BIOPIN-6 placebo implant Placebo Group 1 Intervention

The placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone.

Who Is Running the Clinical Trial?

Drug Delivery Company, LLC DBA Akyso Pharmaceuticals

Lead Sponsor

Trials

1

Recruited

20+

Laboratory Corporation of America

Industry Sponsor

Trials

32

Recruited

18,800+

Cognitive Research Corporation

Industry Sponsor

Trials

25

Recruited

2,400+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Naltrexone implants were found to be more effective than placebo and oral naltrexone in reducing opioid use, based on a systematic review of 5 randomized trials involving 576 participants.

However, the overall quality of evidence regarding the safety and efficacy of naltrexone implants is low, and no significant difference in opioid use was found when compared to methadone maintenance, indicating a need for better-designed studies before widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of naltrexone implants for the treatment of opioid dependence. Larney, S., Gowing, L., Mattick, RP., et al.[2018]

The FDA-approved extended-release formulation of naltrexone, administered as a monthly injection, may improve adherence and retention rates in treating opioid dependence compared to the oral form, which has low compliance (less than 30%).

While naltrexone effectively reduces the rewarding effects of opioids to prevent relapse, there are safety concerns, including potential liver damage at high doses and risks of opioid overdose if individuals attempt to overcome the drug's antagonistic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone extended-release injection: an option for the management of opioid abuse. Taylor, R., Raffa, RB., Pergolizzi, JV.[2021]

Implantable naltrexone (NIT) therapy for opiate dependence resulted in significantly longer treatment durations and fewer treatment episodes compared to buprenorphine (BUP), indicating it may be a more efficient treatment option.

The safety profile of NIT was favorable, with only 1% of patients experiencing serious local tissue reactions or infections, suggesting that it does not compromise safety while economizing treatment resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative treatment and mortality correlates and adverse event profile of implant naltrexone and sublingual buprenorphine. Reece, AS.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06216132?term=Naltrexone%20AND%20peak&viewType=Table&checkSpell=&rank=1

Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults The purpose of this study is to evaluate the safety and blood levels of a medicine, naltrexone , contained within an implant in healthy volunteers age 18 to ...

2. ctv.veeva.com ctv.veeva.com/study/a-phase-1-placebo-controlled-single-ascending-dose-study-of-biopin-6-in-healthy-adults

Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults The purpose of this study is to evaluate the safety and blood levels of a medicine, naltrexone, contained within an implant in healthy volunteers age 18 to 65 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11310269/

Bioabsorbable, subcutaneous naltrexone implants mitigate ... Bioabsorbable, extended‐release BIOPIN naltrexone implants are effective in mitigating fentanyl‐induced respiratory depression in male canines at about 3 ...

4. withpower.com withpower.com/trial/phase-1-opioid-related-disorders-3-2024-d5459

Naltrexone Implant for Opioid Use Disorder Research shows that naltrexone implants can improve long-term outcomes for people with opioid use disorder by increasing abstinence rates and compliance ...

5. addiction-behavioral-conferences.magnusgroup.org addiction-behavioral-conferences.magnusgroup.org/program/scientific-program/2025/a-long-acting-naltrexone-implant-for-opioid-use-disorder-first-in-human-phase-i-trial

A Long-Acting Naltrexone Implant (for Opioid Use Disorder BIOPIN is a novel, bioabsorbable subcutaneous implant designed to achieve therapeutic plasma NTX levels for 6–12 months following a single administration.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07064564?term=low%20dose%20naltrexone&aggFilters=status:not%20rec%20enr%20act&viewType=Table&rank=5

BIOPIN 101b: Pharmacokinetics and Safety Study of Low ... This is a Phase 1b clinical study testing a new extended-release implant that delivers naltrexone , a medication used to treat opioid use disorder (OUD).