Buprenorphine for Opioid Use Disorder
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Friends Research Institute, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 jurisdictions
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.
Is the drug Buprenorphine/Naloxone a promising treatment for opioid use disorder?Yes, Buprenorphine/Naloxone is a promising drug for treating opioid use disorder. It helps people recover by improving treatment outcomes and can be used in various settings, including primary care. It is effective in managing withdrawal symptoms and supporting long-term recovery.467910
What safety data exists for buprenorphine treatment for opioid use disorder?Buprenorphine, often combined with naloxone, is used to treat opioid use disorder and reduce mortality. The combination is designed to reduce misuse potential, with naloxone having low sublingual bioavailability and generally mild adverse effects. However, some clinical experiences suggest these effects may be more significant, potentially affecting patient-provider relationships and care access. Buprenorphine has an abuse potential similar to morphine, but the combination with naloxone may reduce parenteral abuse. In clinical trials, buprenorphine/naloxone showed high treatment retention and reduced opioid cravings, with a tolerability profile consistent with other formulations. Despite some reports of negative experiences with the combination in IV drug users, it is considered a feasible tool for reducing IV abuse.12589
What data supports the idea that Buprenorphine for Opioid Use Disorder is an effective drug?The available research shows that Buprenorphine, often combined with Naloxone, is effective in treating opioid use disorder. It helps reduce opioid cravings and withdrawal symptoms, leading to high treatment retention rates. For example, studies have shown that patients using Buprenorphine/Naloxone have a high preference for this combination due to its better taste and faster dissolve time, which can improve adherence to the treatment. Additionally, this combination reduces the risk of misuse compared to Buprenorphine alone, making it a safer option for patients. Overall, Buprenorphine/Naloxone expands treatment options and is generally well-tolerated by patients.23459
Do I have to stop taking my current medications for this trial?Yes, you must stop taking benzodiazepines and cannot be enrolled in a methadone maintenance program or taking long-acting naltrexone.
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
I am between 18 and 65 years old.
Exclusion Criteria
I can understand and pass a quiz about the study.
I am currently using benzodiazepines, like Valium or Xanax.
I do not have current psychosis or thoughts of harming myself.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: BBTExperimental Treatment1 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: TAUActive Control1 Intervention
Participants will receive a referral to buprenorphine treatment in the community.
Buprenorphine/Naloxone is already approved in United States, 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Division of Parole & ProbationBaltimore, MD
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Who is running the clinical trial?
Friends Research Institute, Inc.Lead Sponsor
References
Socio-demographic profile and help-seeking behaviour of buprenorphine abusers in Singapore. [2020]The US Food and Drug Administration (FDA) approved buprenorphine or Subutex for the treatment of opiate dependence in October 2002. Buprenorphine is a partial agonist of the mu-opioid receptor; although initial animal research suggested a low abuse potential for buprenorphine, it was subsequently shown to have an abuse potential similar to that of morphine or hydromorphone. The objectives of this study were to establish the sociodemographic profile and help-seeking behaviour of buprenorphine abusers attending the deaddiction treatment clinics of the Community Addictions Management Programme.
Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. [2015]Buprenorphine (Subutex) is widely abused in Finland. A combination of buprenorphine plus naloxone (Suboxone) has been available since late 2004, permitting a comparison of the abuse of the two products among untreated intravenous (IV) users. A survey was distributed to attendees at a Helsinki needle exchange program over 2-weeks in April, 2005, At least 30% were returned anonymously. Survey variables included: years of prior IV opioid abuse, years of buprenorphine abuse, frequency, dosage, route of administration and reasons for use, concomitant IV abuse of other substances and amount paid on the street for both buprenorphine and buprenorphine+naloxone. Buprenorphine was the most frequently used IV drug for 73% of the respondents. More than 75% said they used IV buprenorphine to self-treat addiction or withdrawal. Most (68%) had tried the buprenorphine+naloxone combination IV, but 80% said they had a "bad" experience. Its street price was less than half that of buprenorphine alone. The buprenorphine+naloxone combination appears to be a feasible tool, along with easier access to addiction treatment, for decreasing IV abuse of buprenorphine.
Preference for buprenorphine/naloxone and buprenorphine among patients receiving buprenorphine maintenance therapy in France: a prospective, multicenter study. [2015]Maintenance treatment with buprenorphine tablets (Subutex) has been associated with reductions in heroin use; however, concerns for intravenous misuse exist. A buprenorphine/naloxone formulation (Suboxone) was designed to reduce this misuse risk while retaining buprenorphine's efficacy and safety. This prospective, open-label, multicenter trial compared preferences for buprenorphine and buprenorphine/naloxone in 53 opioid-dependent patients stabilized on buprenorphine. Buprenorphine was first administered at the patient's current dose (Days 1-2), followed by a direct switch to buprenorphine/naloxone (Days 3-5). Global satisfaction rates were high and similar between buprenorphine and buprenorphine/naloxone; however, patients preferred the tablet taste, size, and sublingual dissolution time of buprenorphine/naloxone. At the end of the study, 54% of patients preferred buprenorphine/naloxone, 31% preferred buprenorphine, and 15% had no preference; most patients (71%) wished to continue treatment with buprenorphine/naloxone. This study did not identify any impediments to a direct buprenorphine-to-buprenorphine/naloxone switch and revealed some characteristics that may facilitate treatment with buprenorphine/naloxone.
Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. [2020]Buprenorphine is an efficacious, widely used treatment for opioid use disorder (OUD). Daily oral transmucosal formulations can be associated with misuse, diversion, and nonadherence; these limitations may be obviated by a sustained release formulation.
Buprenorphine/Naloxone (Zubsolv®): A Review in Opioid Dependence. [2021]A new sublingual buprenorphine/naloxone tablet (hereafter referred to as buprenorphine/naloxone; Zubsolv®), combining a long-acting partial µ receptor agonist and an opioid antagonist, is approved for the treatment of opioid dependence in adults and adolescents aged > 15 years. This formulation has a higher bioavailability, better taste and faster sublingual dissolve time than a reference sublingual buprenorphine/naloxone tablet (Suboxone®), advantages that provide greater patient preference (potentially improving adherence) and importantly may reduce the risk of buprenorphine parenteral abuse by providing similar buprenorphine exposure at an ≈ 30% lower dosage than reference buprenorphine/naloxone. In large phase III trials of up to 28 days, buprenorphine/naloxone was associated with high treatment retention rates during the induction and stabilization phases, and also reduced opioid craving and opioid withdrawal symptoms. Although noninferiority of buprenorphine/naloxone to sublingual buprenorphine tablet during the 2-day induction phase was only shown in one of the two similarly designed trials, pooled analyses confirmed that treatment retention rates were similar in the buprenorphine/naloxone and buprenorphine groups. Where evaluated, noninferiority of buprenorphine/naloxone to sublingual buprenorphine/naloxone film (only approved in the USA) was also demonstrated at 15 days in the stabilization phase. During the 24-week extension study, buprenorphine/naloxone maintenance therapy sustained improvements in opioid craving and addiction severity scores. Buprenorphine/naloxone was generally well tolerated, displaying a tolerability profile that was generally consistent with that seen with reference buprenorphine/naloxone. In conclusion, with potentially greater patient preference and a lower potential for parenteral buprenorphine abuse than reference buprenorphine/naloxone, buprenorphine/naloxone expands the treatment options available for adults and adolescent (aged > 15 years) patients with opioid dependence.
Approach to buprenorphine use for opioid withdrawal treatment in the emergency setting. [2019]Opioid use disorder (OUD) is increasing in prevalence throughout the world, with approximately three million individuals in the United States affected. Buprenorphine is a medication designed, researched, and effectively used to assist in OUD recovery.
Increasing Access to Medications for Opioid Use Disorder in Primary Care: Removing the Training Requirement May Not Be Enough. [2021]Substance use disorders, including opioid use disorder (OUD), are understood as chronic diseases with a relapsing and remitting course and no known cure. Medications for OUD (MOUD) are well established with decades of evidence supporting their safety and efficacy; however, treatment access remains poor and inequitable. Buprenorphine is an MOUD that can be prescribed in a primary care outpatient setting, although regulatory and administrative challenges are a barrier to prescribing it. Recent regulatory changes offer an opportunity to expand the number of family doctors who treat OUD.
The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? [2023]Because opioid overdose deaths in the United States continue to rise, it is critical to increase patient access to buprenorphine, which treats opioid use disorder and reduces mortality. An underrecognized barrier to buprenorphine treatment (both for maintenance and treatment of acute withdrawal) is limited access to buprenorphine monoproduct. In the United States, buprenorphine is primarily prescribed as a combination product also containing naloxone, added to reduce the potential for misuse. Because naloxone has relatively low sublingual bioavailability compared with buprenorphine, adverse effects are generally considered mild and rare. The authors' clinical experience, however, suggests that adverse effects may be less benign than generally accepted and can have negative effects for the patient, the provider-patient relationship, and the health care system as a whole. The insistence on prescribing combination product can foster stigma and mistrust, creating barriers to care and increased risk of overdose and death.
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]Buprenorphine-naloxone is a medication shown to improve outcomes for individuals seeking treatment for opioid use disorder (OUD); however, outcomes are limited by low medication adherence rates. This is especially true during the early stages of treatment.
Use of intravenous buprenorphine microdosing to initiate medication for opioid use disorder in a patient with co-occurring pain: case report. [2023]Buprenorphine is used to treat opioid use disorder (OUD). However, therapy is often disrupted during acute pain episodes, and re-initiation is often deferred due to intolerable interruption in opioid analgesics. This case report describes a unique strategy for inducing buprenorphine without stopping opioid analgesics.