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

Trial Summary

What is the purpose of this trial?

This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program.

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 buprenorphine/naloxone safe for humans?

Buprenorphine/naloxone is generally well tolerated in humans, with mild and rare adverse effects. It is used to treat opioid dependence and has a safety profile consistent with other similar treatments. ^{1 2 3 4 5}

What makes the drug Buprenorphine/Naloxone unique for treating opioid use disorder?

Buprenorphine/Naloxone is unique because it combines two components: buprenorphine, which reduces cravings and withdrawal symptoms, and naloxone, which helps prevent misuse. This combination is often used in a daily oral form, but newer sustained-release formulations can help improve adherence and reduce the risk of misuse. ^{3 6 7 8 9}

Eligibility Criteria

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

I am between 18 and 65 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? [2023]

2. Singapore pubmed.ncbi.nlm.nih.gov

Socio-demographic profile and help-seeking behaviour of buprenorphine abusers in Singapore. [2020]

3. England 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. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Buprenorphine/Naloxone (Zubsolv®): A Review in Opioid Dependence. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. [2020]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Approach to buprenorphine use for opioid withdrawal treatment in the emergency setting. [2019]

9. England 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. [2022]