Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

Naltrexone (NTX) is a medication that helps people with opioid and alcohol dependence. It works by blocking the effects of opioids like heroin in the body. In the United States, participants can get NTX in two forms: a pill participants take once a day (Revia) and a shot participants get once a month (Vivitrol). Even though NTX is good at stopping the effects of opioids, some people find it hard to take it regularly. That's why scientists are looking into making a new version of NTX that participants only need to take once a month. This could make it easier for people with opioid use problems to stick with their treatment plan. The device being tried out in this research is called BIOPIN-6. It's made to stay in the body for more than a month. The study will go on for three months and aims to check if the BIOPIN-6 is safe and how much medicine it releases into the blood. Once the three months are up, the device will be taken out. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06216132
Study type	Interventional
Source	Drug Delivery Company, LLC DBA Akyso Pharmaceuticals
Contact
Status	Enrolling by invitation
Phase	Phase 1
Start date	June 11, 2024
Completion date	November 11, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06021431` - Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT	N/A
Completed	`NCT06266572` - Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment	Phase 1
Recruiting	`NCT05037682` - Pain and Opioid Management in Older Adults	N/A
Completed	`NCT06200740` - Remotely Observed Methadone Evaluation	N/A
Not yet recruiting	`NCT06441604` - Extended-release Buprenorphine as a Novel Low-dose Induction Strategy	Phase 2
Recruiting	`NCT06028126` - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial	N/A
Completed	`NCT02440256` - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial	N/A
Completed	`NCT02593474` - Medication-Assisted Treatment for Youth With Substance Use Disorders	Phase 1
Completed	`NCT02559973` - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder	Phase 1
Completed	`NCT05587998` - A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.	Phase 1
Terminated	`NCT04577144` - An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
Recruiting	`NCT06001437` - Following Outcomes Remotely Within Addiction Recovery Domains
Recruiting	`NCT05976646` - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion	Phase 1/Phase 2
Completed	`NCT05546229` - Assessment of Methadone and Buprenorphine in Interstitial Fluid
Not yet recruiting	`NCT06104280` - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment	N/A
Not yet recruiting	`NCT06416020` - Integrating MOUD in African American Community Settings (Better Together)	N/A
Recruiting	`NCT06206291` - Cannabidiol for Opioid Addiction	Phase 2
Completed	`NCT05552040` - START NOW in the Treatment of Opioid Addicted Individuals	N/A
Recruiting	`NCT05459922` - Adjunctive Bright Light Therapy for Opioid Use Disorder	N/A
Recruiting	`NCT05343169` - Community-based Education, Navigation, and Support Intervention for Military Veterans	N/A