Buprenorphine for Opioid Use Disorder
Recruiting in 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.
Must be taking: Buprenorphine
Must not be taking: Benzodiazepines, Methadone, Naltrexone
Disqualifiers: Psychosis, Suicidal ideation, others
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.
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.
12345What 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.
36789Eligibility 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.
+2 more
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
+4 more
Trial 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
Participant Groups
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
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.
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.
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.
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.
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.
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.
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.
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.
A machine learning based two-stage clinical decision support system for predicting patients' discontinuation from opioid use disorder treatment: retrospective observational study. [2022]Buprenorphine is a widely used treatment option for patients with opioid use disorder (OUD). Premature discontinuation from this treatment has many negative health and societal consequences.