Naltrexone Implant for Opioid Use Disorder

Overseen By Eva Kemper, MSHS

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Drug Delivery Company, LLC DBA Akyso Pharmaceuticals

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.

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.

Treatment Details

Interventions

• BIOPIN-6 Naltrexone Implant (Opioid Antagonist)

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+