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Opioid Antagonist

BICX104 for Opioid Use Disorder

Phase 1
Waitlist Available
Research Sponsored by BioCorRx Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 168 days
Awards & highlights

Study Summary

This trial is testing a new way to deliver naltrexone, a drug used to treat alcoholism, and comparing it to the current standard of care. The study will last 6 months and will involve people who do not have alcoholism.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~168 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic parameter: AUC
Pharmacokinetic parameter: Cmax.
Pharmacokinetic parameter: Css.
+3 more
Secondary outcome measures
Safety Parameter: AEs

Side effects data

From 2019 Phase 2 trial • 29 Patients • NCT03008590
7%
Dizziness
3%
Infections, minor viral or bacterial
3%
Ankle injury
3%
Fatigue
3%
Lip and tongue swelling
3%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
During Placebo Treatment
During Naltrexone Treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BICX104Experimental Treatment1 Intervention
BICX104 is an eroding implantable pellet that contains 1 g naltrexone and 11 mg magnesium stearate that will be inserted subcutaneously. It will be administered once for 84 days.
Group II: VivitrolActive Control1 Intervention
Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BICX104
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioCorRx Pharmaceuticals, Inc.Lead Sponsor
BioCorRx IncLead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,445 Previous Clinical Trials
2,593,952 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study actively seeking individuals aged eighty-five and older as participants?

"Enrolment in this trial is limited to those aged 18-50. By contrast, there are 25 trials that accept minors and 274 studies recruiting seniors over the age of 65."

Answered by AI

Could you provide a synopsis of research conducted using BICX104?

"Currently, there are 46 active clinical studies being conducted on the effects of BICX104. Of those trials, 12 have reached Phase 3. This medication is widely tested in New york with 161 sites hosting related studies."

Answered by AI

What is the maximum capacity for this medical trial?

"Affirmative. According to the details found on clinicaltrials.gov, this experiment was announced on June 17th 2022 and has recently been updated in July 18 of the same year. 24 volunteers are needed from one medical centre for enrollment in this trial."

Answered by AI

What prerequisites must an individual satisfy to participate in this research endeavor?

"This clinical trial is open to 24 individuals aged 18-50 with an active opioid use disorder diagnosis. In order to join, participants must be willing and able to provide informed consent as well posses a BMI between 18.5 - 30 kg/m2 and weigh 100-180 pounds. Additionally, they cannot have any other substance abuse diagnoses (unless in sustained remission). Finally, both sexes are expected to practice reliable contraception methods over the course of their participation in this experiment (<1% failure rate per year)."

Answered by AI

Has BICX104 received regulatory authorization from the FDA?

"The safety of BICX104 is provisionally estimated to be a score of 1, given the fact that this project is in its early stages with minimal evidence for efficacy and safety."

Answered by AI

What are the common applications of BICX104?

"BICX104 is primarily used to manage weight. However, its applications range from promoting physical activity and managing pain to supporting reduced-calorie diets."

Answered by AI

Is enrollment for this research program available at the moment?

"According to clinicaltrials.gov, this experiment is actively seeking participants and was last modified on July 18th 2022 since it's initial posting on June 17th 2022."

Answered by AI
~9 spots leftby Mar 2025