BICX104 for Opioid Abuse

Phase-Based Estimates
Orange County Research Center, Tustin, CA
+1 More
BICX104 - Drug
18 - 65
All Sexes
Eligible conditions
Opioid Abuse

Study Summary

Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections

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Eligible Conditions

  • Opioid Abuse
  • Opioid-Related Disorders
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether BICX104 will improve 6 primary outcomes and 1 secondary outcome in patients with Opioid Abuse. Measurement will happen over the course of 140 Days.

140 Days
Pharmacokinetic parameter: AUC
Pharmacokinetic parameter: Cmax.
Pharmacokinetic parameter: Css.
Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone.
Pharmacokinetic parameter: Tlast.
Pharmacokinetic parameter: Tmax.
168 Days
Safety Parameter: AEs

Trial Safety

Trial Design

2 Treatment Groups


This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. BICX104 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

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.
Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days.

Trial Logistics


Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 168 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 168 days for reporting.

Closest Location

Orange County Research Center - Tustin, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing and able to provide informed consent.
Without current non-remitted DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) - Substance Use Disorders diagnoses; subjects with a sustained remission diagnosis are not excluded.
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.
Weight of 100-180 pounds, and a BMI of 18.5 to 30 kg/m2, inclusive.
You are a female or male aged 18-50 years old. show original
You must agree to comply with all study requirements and be willing to complete the entire study. show original
You are female of childbearing potential and willing to practice an effective method(s) of birth control for the duration of participation in the study. show original

Patient Q&A Section

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

How many people get opioid abuse a year in the United States?

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Most people getting treated for opioid dependence are not using prescription opioids (PO). According to this survey, in one out of every 12 people PO abuse increased annually between 2004 and 2007, and by one out of every 11 people PO abuse increased annually between 2003 and 2006. It needs to be noted that the increase to opioid abuse was from a small set of users and that the increasing number of PO abusers was primarily from the subset of people using prescription PO. More specifically, PO abuse increased 1.1% annually in 2004-2005 and 0.3% annually both in 2003-2004 and in 2003-2004.

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Can opioid abuse be cured?

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A number of factors can be identified, including the need for effective treatment programs that minimize risk factors, enhance motivation and adherence and the use of more direct forms of supervision that address the core deficits present in opioid addiction.

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What causes opioid abuse?

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The drug of choice for most abusers in the United States is the opiate fentanyl, or an analogue containing this molecule such as the combination product OxyContin. Methadone is generally used by users who are methadone-dependent. Although opiates were once widely used in the USA, their use declined following the introduction of naloxone (OxyContin was developed in the 1970s). It is estimated that between 40 and 80% of American opioid abusers are prescribed for [chronic pain](, but the majority of these are currently prescribed for more acute pain. Methadone is often prescribed for the treatment of acute or mild pain.

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What is opioid abuse?

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Opioid abuse is a relatively recent phenomenon in the US and is a growing health concern. The increased availability of prescription opiates due to the growth of pain management and increased attention to prescribing medication for chronic pain in particular has created opportunities for abuse of prescription opiates. The opioid abuse epidemic is in full swing. This is especially prevalent to younger Caucasian males aged from 15 to 25.

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What are common treatments for opioid abuse?

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There is no single common treatment for this serious condition; treatment must be provided by an experienced addiction specialist. If available, a detoxified, opioid-dependent patient can often be given subanine, but it should be carefully monitored in this patient population. Treatment may be continued for as long as the need exists, and the patient needs to remain in the program as long as it works. However, some patients may be admitted to a long-stay detoxification unit, and require longer intensive treatment in this unit until all the underlying health problems have been treated to enable safe discharge. Follow-up treatment may be needed to keep patients from repeating their old ways, and to prevent relapse even after successful detoxification.

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What are the signs of opioid abuse?

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The signs of opioid abuse are the same as with alcohol use. Symptoms are similar too: insomnia, dizziness, muscle cramps, dizziness, headache, and dry mouth. Severe drug seeking in opiate/opioid abusers may also be seen. Clinicians should be suspicious when faced with multiple complaints, including medical and psychological problems. These patients may be at higher risk for a co-occurrence of multiple substance use disorders. As of this time, there is no test to rule out opioid abuse in a clinical setting, and diagnosis can only be based on clinical history of recent drug use.

Unverified Answer

Is bicx104 safe for people?

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Bicx104 is well tolerated by healthy volunteers and has no detectable binding to opioid receptors in vivo, thus limiting possible toxicities in people. Based on existing data from animals, Bicx104 appears not to be an agonist or prodrug for opioid receptors.

Unverified Answer

What is bicx104?

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Results from a recent clinical trial indicate that the C-terminal half fragment of Bicx104 may serve as a novel biomarker of alcohol abuse. The physiological function of Bicx104 remains to be explored.

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Does opioid abuse run in families?

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Opioid dependence is highly heritable in families in which the probands are affected. In contrast to most other psychiatric disorders in which genetic factors account for up to 20% of cases, the heritability of opioid dependence is higher (approximately 68%).

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What is the primary cause of opioid abuse?

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A review of the most comprehensive dataset to date provided some support for the theory that sex/race/ethnicity/income disparities contribute to higher rates of [inpatient abuse among women of African-American, Mexican, and Caucasian-American backgrounds]and heroin use among African-Americans.

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What is the latest research for opioid abuse?

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[Opioid abuse is a highly publicized problem in the United States. The Centers for Disease Control and Prevention (CDC) has reported an escalation in this issue during the past decade. The current research is focused primarily on the pathophysiology of opioid use and overdose, identifying the different types of opioid abuse/misuse, examining the influence of prescription opioids and illicit use on the health and well-being of those exposed to them, and exploring the use of pharmacogenetics and pharmacotherapies to prevent and treat this problem.] Opioid use is one of the most serious health issues facing our society. There are significant long-term problems that result from unregulated and unmonitored opioid use.

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Does bicx104 improve quality of life for those with opioid abuse?

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Bicx104 was generally well tolerated and improves quality of life compared to placebo. Patients receiving Bicx104 reported increased optimism (increases confidence of success), less fear of relapse (lower levels of anxiety about potential relapse) and less depression (decreases feelings of hopelessness and sadness caused by depression/anxiety). Results from a recent paper did not address the safety of long-term use of Bicx104. A phase 2 trial is planned to investigate the safety and efficacy of Bicx104 after discontinuation of therapy.

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