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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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 years. To do this, the implant containing the drug will be inserted under the skin, left in place for 3 months and then removed.

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 data supports the effectiveness of the drug BIOPIN-6 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 compared to oral naltrexone. Studies also indicate that naltrexone implants help maintain an opiate-free lifestyle more effectively than some other treatments. ^{1 2 3 4 5}

Is the naltrexone implant generally safe for humans?

Naltrexone implants have been studied for treating opioid dependence, and research shows they have minimal or manageable safety concerns. Some studies report that naltrexone implants are generally safe, with few adverse events, but there are concerns about liver damage at high doses and potential opioid overdose if opioids are used to overcome the implant's effects. ^{1 4 6 7 8}

How is the BIOPIN-6 Naltrexone Implant different from other drugs for opioid use disorder?

The BIOPIN-6 Naltrexone Implant is unique because it is a subcutaneous (under the skin) implant that provides a sustained release of naltrexone, which helps maintain consistent drug levels in the body for an extended period, improving compliance compared to oral naltrexone. This method can offer longer-lasting effects, reducing the need for frequent dosing and potentially improving treatment retention. ^{1 6 9 10 11}

Research Team

Todd Bertoch, MD

Principal Investigator

Cenexel JBR

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

3 sequential cohorts receiving 4.8, 9.6, or 14.4 g 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+

Findings from Research

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]

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]

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]

References

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

Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone. [2021]

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

A comparison of oral and implant naltrexone outcomes at 12 months. [2019]

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

Open label trial of naltrexone implants: measuring blood serum levels of naltrexone. [2021]

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

Epidemiologic and molecular pathophysiology of chronic opioid dependence and the place of naltrexone extended-release formulations in its clinical management. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of naltrexone implant and oral buprenorphine-naloxone in the treatment of opiate use disorder. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of naltrexone implants for the treatment of opioid dependence. [2018]

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

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

8. New Zealand pubmed.ncbi.nlm.nih.gov

Naltrexone extended-release injection: an option for the management of opioid abuse. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Unplanned admissions to two Sydney public hospitals after naltrexone implants. [2021]

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

Maintenance treatment with depot opioid antagonists in subcutaneous implants: an alternative in the treatment of opioid dependence. [2013]

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

Blood naltrexone and 6-beta-naltrexol levels following naltrexone implant: comparing two naltrexone implants. [2013]