Healthy Adult Male and Female Volunteers study: Bupropion vs Naltrexone
Official title Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
ClinicalTrials.gov ID: NCT07269873
What this study is testing
What is BICX104 naltrexone implantable pellet?
An investigational implantable pellet that is being studied as a potential long‑term delivery system for naltrexone. It is designed to release naltrexone slowly into the bloodstream over several months.
Also referred to as naltrexone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to evaluate how safe the BICX104 implant is and how the drug stays in the body over time, both alone and with bupropion, compared to the standard Vivitrol injection.
- Who it's for
- Healthy adult men and women, about half male and half female, with no medical conditions that would interfere with the study.
- What's involved
- Participants will receive either one or two BICX104 implants, sometimes together with daily bupropion tablets, or receive Vivitrol injections. They will have 18 clinic visits over 31 weeks, including a 3‑day overnight stay for the first dose, blood tests, safety checks, and heart‑rate monitoring.
- Time commitment
- The study lasts 31 weeks (about 7 months) with visits every few weeks; the last safety visit is on day 196, about 28 weeks after the final dose.
- Phase 1: an early, usually small safety study
- Time commitment: about 31 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Willing and able to provide informed consent and to read and understand study documents in English or Spanish
- Female or male people aged 18-65 years old
- In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and...
- Meet subjective and objective measures of being opioid-free prior to study treatment initiation, including negative urine drug screen results at...
- BMI of 18.5 to 30.0 kg/m2, inclusive.
You likely can't join if
- Have a history of any psychiatric disorder OR suicidal ideation, behavior, or risk of self-harm as evidenced by endorsement of items 2, 3, 4, or 5 on...
- Have a history of angle-closure glaucoma
- Have a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization)
- Have evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc interval (\> 450 in males or \> 470...
- Have Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160/100 in 2 out of 3 readings during...
- Have any elevated bilirubin test value, or AST, ALT or alkaline phosphatase \> 1.5 times the upper limit of normal, per laboratory criteria
See the full eligibility criteria
- Willing and able to provide informed consent and to read and understand study documents in English or Spanish
- Female or male people aged 18-65 years old
- In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests within normal ranges, to permit treatment.
- Meet subjective and objective measures of being opioid-free prior to study treatment initiation, including negative urine drug screen results at screening and enrollment.
- BMI of 18.5 to 30.0 kg/m2, inclusive.
- Must agree to comply with all study requirements and be willing to complete entire study.
- Persons of childbearing potential agree to use acceptable birth control methods and have periodic urine pregnancy testing done during participation in the study
- Have a history of any psychiatric disorder OR suicidal ideation, behavior, or risk of self-harm as evidenced by endorsement of items 2, 3, 4, or 5 on the C-SSRS
- Have a history of angle-closure glaucoma
- Have a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia
- Have evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc interval (\> 450 in males or \> 470 in females), or any other finding on the screening ECG that, in the...
- Have Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160/100 in 2 out of 3 readings during screening)
- Have any elevated bilirubin test value, or AST, ALT or alkaline phosphatase \> 1.5 times the upper limit of normal, per laboratory criteria
- Have a platelet count \<100 x 103/μL; known coagulopathy, or need for anticoagulant therapy during the study
- Have a known allergy or sensitivity to bupropion, naltrexone, or magnesium stearate, or any topical antiseptics or local anesthetics to be used in the implant procedure.
- Have taken an investigational drug in another study within 30 days of study consent
- Have a history of any substance abuse disorder, have been prescribed and taken naltrexone or bupropion within 30 days of study consent, or have been administered Vivitrol® within 60 days of study consent
- Be receiving ongoing treatment with antidepressants, xanthines (i.e., theophylline and aminophylline), systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous system stimulants (e.g...
- Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the study medical clinician
- Require treatment with opioid-containing medications (e.g., opioid analgesics) during the study period
- Have a surgery planned or scheduled during the study period
- Are currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that could prevent participation in the...
- Is prone to skin rashes, keloid scars, or irritation, or has a chronic skin condition or any other condition which might predispose them to adverse reactions to the implant procedure.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 31 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.