Buprenorphine for Opioid Use Disorder

Overseen By Frank J Vocci, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Friends Research Institute, Inc.

Must be taking: Buprenorphine

Must not be taking: Benzodiazepines, Methadone, Naltrexone

Disqualifiers: Psychosis, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 months

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of buprenorphine for individuals with opioid use disorder, particularly those on parole or probation. Researchers aim to determine if immediate buprenorphine treatment is more beneficial than referrals to community treatment programs. Participants will either receive buprenorphine at a community supervision office or a referral to community treatment. Individuals on parole or probation in Baltimore City with a diagnosis of moderate to severe opioid use disorder may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you stop using benzodiazepines (like Valium or Xanax) and you cannot be enrolled in a methadone maintenance program or taking long-acting naltrexone. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that buprenorphine/naloxone is a safe treatment for opioid addiction. Past studies demonstrated that this medication lowers death rates and increases recovery rates for patients. The FDA has approved it for treating opioid addiction, confirming its safety.

Although individuals may be more likely to stop using buprenorphine/naloxone compared to methadone, it remains a well-tolerated option. Overall, evidence indicates that buprenorphine/naloxone is generally safe for treating opioid addiction. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the buprenorphine/naloxone treatment for opioid use disorder because it introduces a unique delivery method via the MedicaSafe buprenorphine dispensing device. Unlike standard care options that often involve outpatient clinic visits for medication management, this new method allows for immediate, on-site initiation of treatment at community supervision offices. This could enhance access and adherence to the treatment, which is crucial for individuals transitioning back into community life. By facilitating quicker and more streamlined access to buprenorphine therapy, this approach has the potential to improve outcomes and reduce the risk of relapse.

What evidence suggests that buprenorphine/naloxone might be an effective treatment for opioid use disorder?

Research has shown that buprenorphine-naloxone effectively treats opioid addiction. Studies have found that this medication reduces the risk of opioid overdose by 36%. It also significantly lowers death rates and helps more people remain free from addiction. In this trial, participants in the BBT arm will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device. Meanwhile, participants in the TAU arm will receive a referral to buprenorphine treatment in the community. Comparisons between buprenorphine-naloxone and methadone, another treatment, have shown similar results. Overall, buprenorphine-naloxone greatly reduces the chances of dying from an overdose. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with moderate to severe opioid use disorder who live in Baltimore City and are on parole or probation. They must be able to give consent and stay in the study for at least 4 months. People using benzodiazepines, those with certain medical conditions, pending legal issues, or current enrollment in other substance treatment programs cannot join.

Inclusion Criteria

Subject must provide written informed consent prior to the conduct of any study-related procedures

Be on parole or probation for at least the next 4 months

Have a Baltimore City address

Exclusion Criteria

Currently enrolled in a methadone maintenance treatment program or taking long-acting naltrexone

Any pending legal action that would interrupt study participation (eg, pending incarceration, probation/parole revocation, unadjudicated charges)

Exposure to any investigational drug within 8 weeks of screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive buprenorphine bridge treatment (BBT) or treatment as usual (TAU) with referral to community buprenorphine treatment

12 months

Monthly assessments at 1, 2, 3, 6, and 12 months post-intake

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine/Naloxone
• Treatment as usual

Trial Overview

The study compares a 'buprenorphine bridge treatment' (BBT) given directly to individuals on probation or parole against the usual practice of referring them to community buprenorphine programs. The goal is to see if BBT helps more people start and stick with treatment.

How Is the Trial Designed?

Group I: BBT Experimental Treatment 1 Intervention

Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment

Group II: TAU Active Control 1 Intervention

Participants will receive a referral to buprenorphine treatment in the community.

Buprenorphine/Naloxone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Suboxone for:

• opioid dependence
• opioid use disorder

Approved in United States as Zubsolv for:

• opioid dependence
• opioid use disorder

Approved in European Union as Buprenorphine/Naloxone for:

• opioid dependence
• opioid use disorder

Approved in Canada as Suboxone for:

• opioid dependence
• opioid use disorder

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

Published Research Related to This Trial

A unique strategy using intravenous microdosing of buprenorphine allowed for the treatment of opioid use disorder (OUD) in a patient experiencing acute pain without causing withdrawal symptoms or worsening pain.

This approach enabled the successful weaning off full agonist opioids after discharge, demonstrating a potential method for managing OUD while addressing acute pain effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intravenous buprenorphine microdosing to initiate medication for opioid use disorder in a patient with co-occurring pain: case report. Bodnar, A., Diffenderffer, C., Jablonski, LA., et al.[2023]

Increasing access to buprenorphine, a treatment for opioid use disorder, is crucial for reducing overdose deaths, but limited availability of buprenorphine monoproduct is a significant barrier.

The requirement to prescribe buprenorphine as a combination product with naloxone may lead to adverse effects that are more serious than previously thought, potentially harming the patient-provider relationship and increasing stigma, which can hinder access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? Gregg, J., Hartley, J., Lawrence, D., et al.[2023]

Buprenorphine, approved for treating opiate dependence, has been found to have an abuse potential similar to that of traditional opioids like morphine, despite initial beliefs of its low abuse risk.

A study of 120 buprenorphine abusers revealed that the majority were middle-aged males with a significant history of early illicit drug use, highlighting a concerning trend of prescription medication abuse that requires increased awareness and vigilance among healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socio-demographic profile and help-seeking behaviour of buprenorphine abusers in Singapore. Winslow, M., Ng, WL., Mythily, S., et al.[2020]

Buprenorphine is a safe and effective treatment for opioid use disorder (OUD) in emergency departments, acting as a partial mu-opioid receptor agonist with a long half-life and a ceiling effect that reduces the risk of overdose and withdrawal symptoms.

Implementing a buprenorphine program in the ED requires a comprehensive approach that includes medication-assisted treatment, counseling, and addressing the stigma associated with opioid replacement therapies to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to buprenorphine use for opioid withdrawal treatment in the emergency setting. Cisewski, DH., Santos, C., Koyfman, A., et al.[2019]

The study will involve 280 adults with opioid use disorder and aims to improve adherence to buprenorphine-naloxone treatment through two psychological interventions: contingency management (CM) and brief motivational interviewing plus substance-free activities and mindfulness (BSM).

The primary goal is to assess which intervention is more effective in promoting medication adherence, measured by attendance at physician appointments and the presence of buprenorphine in urine toxicology, with follow-up occurring 8 months after randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder. Peter, SC., Murphy, JG., Witkiewitz, K., et al.[2023]

Nearly 49% of patients starting buprenorphine for opioid use disorder discontinued treatment within a year, highlighting a significant challenge in managing this condition.

A machine learning framework was developed that effectively predicts which patients are at risk of discontinuing treatment, improving prediction accuracy by incorporating early medication adherence data, which could help healthcare providers tailor support for at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A machine learning based two-stage clinical decision support system for predicting patients' discontinuation from opioid use disorder treatment: retrospective observational study. Hasan, MM., Young, GJ., Shi, J., et al.[2022]

The new sublingual buprenorphine/naloxone tablet (Zubsolv®) has higher bioavailability and better taste, which may improve patient adherence and reduce the risk of misuse compared to the reference product (Suboxone®).

In large phase III trials lasting up to 28 days, Zubsolv® demonstrated high treatment retention rates and effectively reduced opioid cravings and withdrawal symptoms, making it a viable option for treating opioid dependence in adults and adolescents over 15 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine/Naloxone (Zubsolv®): A Review in Opioid Dependence. Heo, YA., Scott, LJ.[2021]

The novel weekly subcutaneous buprenorphine depot formulation, CAM2038, was found to effectively block the euphoric effects of opioids and suppress withdrawal symptoms in individuals with moderate-to-severe opioid use disorder, based on a study involving 47 participants.

Both doses of CAM2038 (24 mg and 32 mg) were well-tolerated and demonstrated significant efficacy in preventing opioid effects, making it a promising alternative to daily oral formulations that carry risks of misuse and nonadherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. Walsh, SL., Comer, SD., Lofwall, MR., et al.[2020]

A survey of intravenous drug users in Helsinki revealed that 73% used buprenorphine as their primary drug, primarily for self-treating addiction or withdrawal symptoms.

The combination of buprenorphine and naloxone (Suboxone) was tried by 68% of respondents, but 80% reported negative experiences, suggesting that while it may help reduce buprenorphine abuse, its acceptance among users is low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. Alho, H., Sinclair, D., Vuori, E., et al.[2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11610725/

Buprenorphine-Naloxone for Opioid Use Disorder

Buprenorphine-naloxone was associated with significantly reduced mortality and increased remission rates for patients with opioid use disorder.

2.

mdpi.com

mdpi.com/2813-0618/1/3/10

Evaluation of the Effectiveness of Buprenorphine-Naloxone ...

Their results demonstrated that an additional 100-day buprenorphine treatment was associated with a 36% reduction in risk of opioid overdose ...

3.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2825088

Buprenorphine/Naloxone vs Methadone for the Treatment ...

The risk of treatment discontinuation was higher among recipients of buprenorphine/naloxone compared with methadone (88.8% vs 81.5% within 24 months).

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2949875923002606

Evaluation of opioid use disorder treatment outcomes in ...

In this study, patients receiving once daily buprenorphine-naloxone had similar treatment outcomes to patients receiving split dosing.

5.

cdc.gov

cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates

Medications for opioid use disorder (OUD), particularly buprenorphine and methadone, substantially reduce overdose-related and overall mortality ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000MedR.pdf

205637Orig1s000 - accessdata.fda.gov

A recently approved buprenorphine/naloxone product for opioid addiction treatment received a waiver for ages 15 and 16 in addition to ages 12 through 14 ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05644587

NCT05644587 | Novel Induction to Buprenorphine/Naloxone

Primary outcomes include effectiveness and safety. Secondary outcomes include treatment retention, self-reported use of opioids during induction, return to ...