Opioid Use DisorderPhase 1NCT06216132
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults
A Phase 1 study testing BIOPIN-6 Active Implant with Naltrexone in people with Opioid Use Disorder, run by Akyso Therapeutics, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- BIOPIN-6 Active Implant with Naltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 25 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study:
- Healthy male or female volunteer, aged 18-to-55 years, inclusive.
- BMI must be between 18 and 32 kg/m2 (inclusive) and weigh a minimum of 50 kg (110 lbs).
- If female, be postmenopausal (at least 2 years prior to dosing) or agree to use an acceptable form of birth control from screening until 12 weeks after dosing. Subjects who claim postmenopausal status will have status confirmed with a follicle stimulating hormone (FSH) test. Acceptable forms of birth control for females include the following:
- Vasectomized partner (at least 6 months prior to dosing)
- Surgical sterilization (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) at least 6 months prior to dosing
Show all 17Show fewer
- Non-surgical permanent sterilization (eg, Essure procedure) at least 3 months prior to dosing.
- Abstinence (must agree to use a double barrier method if they become sexually active during the study)
- Double barrier (diaphragm with spermicide; condoms with spermicide)
- Oral hormonal contraceptives
- Not Breast feeding
- Negative tests for human immunodeficiency virus (HIV), Hepatitis C antibody, Hepatitis B surface antigen, and Covid
- Able and willing to comply with the requirements of the protocol
- Able and willing to provide written informed consent
- Willing to undergo a minor surgical procedure under local anesthetic to allow for investigational drug administration in the subcutaneous tissue
- Agree to avoid blunt trauma to the implantation site
- Agree that after implantation, not to shower for 2 days and not to bathe/swim for 4 weeks
Who cannot join
- Subjects must have none of the exclusion criteria to be included in the study.
- Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (EKG), or clinical laboratory results at screening. In particular, values of liver function tests (ALT, AST, bilirubin, albumin, GGT) and kidney function tests (creatinine, blood urea nitrogen) and reticulocytes shall not deviate by more than 25% from the ranges of normal.
- Blood pressure: systolic >140 mmHg, diastolic >90 mmHg. [Europe Soc Hypertension guidelines]
- Heart rate: >100 beats/minute.
- Hemoglobin for female <11.5 and for male <12.5 are excluded.
- Have a known or suspected history or family history of adverse reactions or hypersensitivity to the study drugs or to drugs with a similar chemical structure.
Show all 32Show fewer
- History or presence of gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Is on anticoagulant medications other than aspirin or NSAIDs. Agree to stop aspirin or NSAIDs 1 week prior to Biopin 6 implantation
- Used any over-the-counter (OTC) medication, nutritional or dietary supplements, herbal preparations, or vitamins within 7 days prior to the first dose of medication.
- Used any prescription medication within 14 days prior to the first dose of study medication.
- More than moderate drinking averaged over the last month as assessed by history:
- o Moderate drinking is here defined as up to 3 drinks per week. The standard drink will be defined by the guidelines of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and will contain no more than 14 g of alcohol.
- Smoking: Use of tobacco or nicotine-containing products within the 3-month period preceding study drug administration is exclusionary.
- Positive urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, cannabinoids, phencyclidine, propoxyphene, methadone, methaqualone, and alcohol at the screening and Day -1 tests.
- Any methadone use 14 days prior to screening, and up to Study Day -1.
- Has had a naltrexone implant in the past 24 months.
- Has received treatment with an extended naltrexone product (e.g. Vivitrol) in the past 12 months.
- Fails the naloxone challenge test
- Has a condition which requires treatment with opioid based medication.
- Has a known hypersensitivity to naltrexone.
- Has a known hypersensitivity to materials based on poly-d-l Lactic Acid and polycaprolactone (e.g. biodegradable sutures, surgical implants or previous biodegradable implants).
- Has a known hypersensitivity to local anesthesia.
- Is prone to skin rashes, irritation or has a skin condition such as recurrent eczema that is likely to impact the implant site area, or as determined by the evaluating physician.
- Is known to form keloids at the site of skin injury.
- Demonstrates any abnormal skin tissue in the proposed implantation area
- Previous surgery to the upper abdominal wall
- Donated blood or plasma within 30 days prior to the first dose of study medication.
- Participated in another clinical trial within 30 days prior to the first dose of study medication.
- Is participating or intending to participate in any other clinical trial during the duration of this study.
- Any elevated risk for suicide measured using the Columbia Suicide Severity Rating Scale, endorsing any of the items in the past month (C-SSRS, Lifetime)
- Not as much as "mild" depression as measured by the HAM-D17 test: HAM-D17 score must be 0-10.
- Any additional condition(s) that in the investigator's opinion would prohibit the participant from completing the study or would not be in the best interest of the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Placebo-controlled, Single-Ascending-Dose, Study of BIOPIN 6 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 years. To do this, the implant containing the drug will be inserted under the skin, left in place for 3 months and then removed.
Read the detailed 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.
- Conditions
- Opioid Use Disorder
- Being tested
- BIOPIN-6 Active Implant with Naltrexone, BIOPIN-6 Placebo Implant
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOPIN-6 Active Implant with NaltrexoneCombination product
Also called BIOPIN, Subcutaneous naltrexone implant, Extended release naltrexone implant
An extended release formulation of naltrexone implanted in the subcutaneous space.
BIOPIN-6 Placebo ImplantDevice
The placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone.
| Study group | Role | What they receive |
|---|---|---|
| BIOPIN-6 active implant | Experimental | Two sequential cohorts receiving 4.8 or 9.6 BIOPIN 6 implanted into a subcutaneous pocket in the upper abdominal wall. Receives: Combination Product: BIOPIN-6 Active Implant with Naltrexone |
| BIOPIN-6 placebo implant | Placebo comparator | The placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone. Receives: Device: BIOPIN-6 Placebo Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Naltrexone Plasma Concentration Area Under the Curve (AUC₀-Day 98)
Area under the plasma naltrexone concentration-time curve (AUC) from implant placement through Day 98, calculated using noncompartmental pharmacokinetic methods based on serial plasma concentration measurements. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Measured: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
Naltrexone Plasma Levels (Peak)
Naltrexone Peak Plasma Concentration (Cmax) [ng/ml]. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Measured: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
Time to Peak Plasma Concentration of Naltrexone (Tmax)
Time to maximum observed plasma concentration (Tmax) of naltrexone following implant placement.
Measured: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
6-β-naltrexol Plasma Concentration Area Under the Curve (AUC₀-98 Days)
Area under the plasma concentration-time curve (AUC) of 6-β-naltrexol from implant placement through Day 98. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Measured: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
6-β-naltrexol Peak Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) of 6-β-naltrexol following implant placement.[ng/ml]. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Measured: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
Time to Peak Plasma Concentration of 6-β-naltrexol (Tmax)
Time to maximum observed plasma concentration (Tmax) of 6-β-naltrexol following implant placement.
Measured: Day 0 to Day 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start24 Jun 2024
- Primary completion18 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Determine naltrexone and 6b-naltrexole pharmacokinetic parameters in subjects administered a single dose of BIOPIN 6 \[BIOPIN 6 implants containing 4.8g (dose-level #1) or 9.6g (dose-level #2) naltrexone\]. Each of the two dose groups will be compared to a placebo implant group. The initial study design had 3 groups and a high dose group receiving 14.4 g naltrexone. After the PK data became available for the second cohort, the sponsor chose to not proceed with the final cohort because the target PK parameters had been achieved with the 9.6 gram group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akyso Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), Laboratory Corporation of America, Cognitive Research Corporation
- Responsible party
- Sponsor
- Investigators
- Todd Bertoch, MD, Principal investigator, Cenexel JBR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216132
- Sponsor's protocol ID
- BIOPIN101
- Other IDs
- 5UG3DA048338-02
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2023
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-controlled, Single-Ascending-Dose, Study of BIOPIN 6 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06216132
- Acronym / sponsor ID
- BIOPIN101
- Conditions
- Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Akyso Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), Laboratory Corporation of America, Cognitive Research Corporation
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Determine naltrexone and 6b-naltrexole pharmacokinetic parameters in subjects administered a single dose of BIOPIN 6 [BIOPIN 6 implants containing 4.8g (dose-level #1) or 9.6g (dose-level #2) naltrexone]. Each of the two dose groups will be compared to a placebo implant group. The initial study design had 3 groups and a high dose group receiving 14.4 g naltrexone. After the PK data became available for the second cohort, the sponsor chose to not proceed with the final cohort because the target PK parameters had been achieved with the 9.6 gram group.
| Arm | Type | Receives |
|---|---|---|
| BIOPIN-6 active implant | Experimental | Combination Product: BIOPIN-6 Active Implant with NaltrexoneTwo sequential cohorts receiving 4.8 or 9.6 BIOPIN 6 implanted into a subcutaneous pocket in the upper abdominal wall. |
| BIOPIN-6 placebo implant | Placebo comparator | Device: BIOPIN-6 Placebo ImplantThe placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Healthy male or female volunteer, aged 18-to-55 years, inclusive.
- BMI must be between 18 and 32 kg/m2 (inclusive) and weigh a minimum of 50 kg (110 lbs).
- If female, be postmenopausal (at least 2 years prior to dosing) or agree to use an acceptable form of birth control from screening until 12 weeks after dosing. Subjects who claim postmenopausal status will have status confirmed with a follicle stimulating hormone (FSH) test. Acceptable forms of birth control for females include the following:
- Not Breast feeding
- Negative tests for human immunodeficiency virus (HIV), Hepatitis C antibody, Hepatitis B surface antigen, and Covid
Key exclusion criteria (32 listed)
- Subjects must have none of the exclusion criteria to be included in the study.
- Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (EKG), or clinical laboratory results at screening. In particular, values of liver function tests (ALT, AST, bilirubin, albumin, GGT) and kidney function tests (creatinine, blood urea nitrogen) and reticulocytes shall not deviate by more than 25% from the ranges of normal.
- Blood pressure: systolic >140 mmHg, diastolic >90 mmHg. [Europe Soc Hypertension guidelines]
- Heart rate: >100 beats/minute.
- Hemoglobin for female <11.5 and for male <12.5 are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOPIN-6 Active Implant with NaltrexoneAlso: BIOPIN, Subcutaneous naltrexone implant, Extended release naltrexone implantAn extended release formulation of naltrexone implanted in the subcutaneous space. | Combination product | BIOPIN-6 active implant |
| BIOPIN-6 Placebo ImplantThe placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone. | Device | BIOPIN-6 placebo implant |
Primary outcome
Naltrexone Plasma Concentration Area Under the Curve (AUC₀-Day 98)
Time frame: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
Area under the plasma naltrexone concentration-time curve (AUC) from implant placement through Day 98, calculated using noncompartmental pharmacokinetic methods based on serial plasma concentration measurements. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Naltrexone Plasma Levels (Peak)
Time frame: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
Naltrexone Peak Plasma Concentration (Cmax) [ng/ml]. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Time to Peak Plasma Concentration of Naltrexone (Tmax)
Time frame: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
Time to maximum observed plasma concentration (Tmax) of naltrexone following implant placement.
6-β-naltrexol Plasma Concentration Area Under the Curve (AUC₀-98 Days)
Time frame: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
Area under the plasma concentration-time curve (AUC) of 6-β-naltrexol from implant placement through Day 98. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
6-β-naltrexol Peak Plasma Concentration (Cmax)
Time frame: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).
Maximum observed plasma concentration (Cmax) of 6-β-naltrexol following implant placement.[ng/ml]. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Time to Peak Plasma Concentration of 6-β-naltrexol (Tmax)
Time frame: Day 0 to Day 98
Time to maximum observed plasma concentration (Tmax) of 6-β-naltrexol following implant placement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Bertoch, MD principal investigator
Cenexel JBR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIOPIN-6 Active Implant with Naltrexone in people with Opioid Use Disorder, run by Akyso Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naltrexone Plasma Concentration Area Under the Curve (AUC₀-Day 98) (time frame: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.