Buprenorphine for Opioid Use Disorder
(ED-ENVISION Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byGail D'Onofrio, MD, MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Yale University
Must not be taking: Opioid analgesics, Methadone
Disqualifiers: Severe liver failure, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you require ongoing prescription opioid painkillers or have used methadone in the past 72 hours.
What data supports the effectiveness of the drug Buprenorphine for treating opioid use disorder?
Research shows that Buprenorphine, often combined with Naloxone (as in Suboxone), is effective in treating opioid use disorder by improving treatment outcomes. However, challenges like low adherence and misuse exist, which can be addressed with sustained release formulations.
12345Is buprenorphine safe for humans?
Buprenorphine is generally considered safe for treating opioid dependence, with a lower risk of overdose compared to other opioids. However, it can still be abused, especially if not taken as prescribed, and there are risks if it is injected instead of taken as directed.
46789What makes the drug Buprenorphine unique for treating opioid use disorder?
Buprenorphine is unique because it combines a partial mu-receptor agonist (buprenorphine) with an antagonist (naloxone) in a 4:1 ratio, which helps reduce the risk of misuse. It is administered sublingually (under the tongue), making it different from other treatments that may require different routes of administration.
1011121314Eligibility Criteria
This trial is for adults over 18 with moderate to severe opioid use disorder (OUD), who have tested positive for opioids and are not currently on opioid withdrawal treatments. Participants must speak English, be able to consent, and commit to the study's follow-up process. Those with ongoing opioid prescriptions, prior study enrollment, in custody, or with conditions needing hospitalization can't join.Inclusion Criteria
Have a urine toxicology test that is positive for opioids
Be treated in the ED during study screening hours
Meet DSM-5 diagnostic criteria for moderate to severe OUD
+3 more
Exclusion Criteria
I need a prescription for painkillers.
Have prior enrollment in the current study
Be a prisoner or in police custody at the time of index ED visit
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive either Standard Dose Induction (SDI) or High Dose Induction (HDI) of buprenorphine/naloxone
10 days
Daily assessments
Follow-up
Participants are monitored for engagement in OUD treatment and assessed for opioid withdrawal symptoms, cravings, and substance use
30 days
Participant Groups
The trial compares two methods of starting Buprenorphine treatment in emergency department patients: a Standard Dose Induction (SDI) versus a High Dose Induction (HDI). It aims to see which method leads to better engagement in OUD treatment after discharge and assesses withdrawal symptoms and drug cravings.
2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose SL-BUPExperimental Treatment1 Intervention
Participants will receive three 5.7 mg Zubsolv pills; all will be active medication.
Group II: Standard SL-BUPActive Control1 Intervention
Participants will receive three pills; one 5.7 mg Zubsolv pill with active medication and two placebo pills.
Buprenorphine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Buprenorphine for:
- Moderate to severe opioid addiction (dependence)
🇪🇺 Approved in European Union as Buprenorphine for:
- Opioid dependence
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cooper University HospitalCamden, NJ
Maine Medical CenterPortland, ME
University of Utah HospitalSalt Lake City, UT
Highland HospitalOakland, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
The Emmes Company, LLCIndustry Sponsor
Alameda Health SystemCollaborator
National Drug Abuse Treatment Clinical Trials NetworkCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
References
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.
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.
Assessing Motivations for Nonprescribed Buprenorphine Use Among Rural Appalachian Substance Users. [2023]Buprenorphine (Suboxone) is an effective treatment for opioid use disorder (OUD). However, there have been widespread reports of diversion and misuse. This study examined motivations for nonprescribed buprenorphine use among rural residents.
Quantitation of Total Buprenorphine and Norbuprenorphine in Meconium by LC-MS/MS. [2016]Buprenorphine (Suboxone, Zubsolv, Buprenex, Butrans, etc.) is an opioid drug that has been used to treat opioid dependence on an outpatient basis, and is also prescribed for managing moderate to severe pain. Pregnant women may be prescribed buprenorphine as part of a treatment plan for opioid addiction. This chapter quantitates buprenorphine and norbuprenorphine in meconium by liquid chromatography tandem mass spectrometry (LC-MS/MS).
Group medication management for buprenorphine/naloxone in opioid-dependent veterans. [2014]Substance use disorders are a key concern among US veterans. Substance use disorder pharmacotherapies with support for effectiveness are limited. Buprenorphine/naloxone (Suboxone) is an effective opioid replacement treatment option for opioid use disorder when used as part of a comprehensive treatment program. In June 2011, the Veterans Affairs San Diego Healthcare System began using a group format to prescribe buprenorphine/naloxone. This study aimed at examining outcomes of retention rates and percentage opioid negative urine samples. Results were compared for veteran patients seen in group versus individual formats.
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.
Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. [2013]In May 2002 Buprenorphine (Subutex) was listed on the Australian Pharmaceutical Benefits Schedule for treatment in opioid dependence. In addition to broadening treatment options, buprenorphine has the advantage of an improved safety profile. The risk of overdose is lessened but other risks remain due to diversion. French experience reports widespread deviation of buprenorphine sublingual tablets to intravenous injection. We report a case of attempted parenteral administration of buprenorphine tablets. Stringent protocols for dispensing are appropriate.
Opioid drugs in maintenance and detoxification treatment of opiate addiction; addition of buprenorphine and buprenorphine combination to list of approved opioid treatment medications. Interim final rule. [2013]This interim final rule amends the Federal opioid treatment program regulations by adding buprenorphine and buprenorphine combination products to the list of approved opioid treatment medications that may be used in federally certified and registered opioid treatment programs. The Food and Drug Administration (FDA) recently approved Subutex[reg] (buprenorphine) and Suboxone[reg] (buprenorphine in fixed combination with naloxone) for the treatment of opiate dependence. These two products will join methadone and ORLAAM[reg] as medications that may be used in opioid treatment programs for the maintenance and detoxification treatment of opioid dependence. Opioid treatment programs that choose to use these new products in the treatment of opioid dependence will adhere to the same Federal treatment standards established for methadone and ORLAAM[reg]. The Secretary invites public comments on this action.
Buprenorphine maintenance: a new treatment for opioid dependence. [2019]Buprenorphine (Subutex) is a safe and effective treatment for opioid dependence, and has very low potential for abuse, especially when it is combined with naloxone (Narcan) in a single sublingual tablet (Suboxone). New regulations allow physicians who are certified in buprenorphine therapy to offer it in their offices, a development that can substantially increase patient access to treatment.
Zoledronic acid for prevention and treatment of osteoporosis. [2018]Osteoporosis (OP) is associated with a high risk of fracture and disability and with substantial medical costs. This paper is a review of the intravenous (i.v.) bisphosphonate zoledronic acid 5 mg (ZOL), used in the treatment and prevention of OP.
Hospitalisations related to benzodiazepine, Z-drug, and opioid treatment in Italy: a claim on the risks associated with inappropriate use. [2022]Benzodiazepines (BZD), Z-drugs (ZD), and opioids share a high risk of abuse. This study assessed and characterised adverse events (AEs) related to BDZ, ZD, and opioids leading to emergency department (ED) visits in the Italian setting.
Role of zoledronic acid in the prevention and treatment of osteoporosis. [2023]Taken once a year, intravenous zoledronic acid (Zol) (Reclast® or Aclasta®) is a third-generation nitrogen-containing bisphosphonate that is effective compared with placebo in reducing the risk of fractures in patients with postmenopausal osteoporosis and recent low-trauma hip fracture. In glucocorticoid-induced osteoporosis, there is no significant difference between Zol and risedronate for new fractures. Improvements in bone mineral density and early reduction of bone remodeling markers are observed in postmenopausal osteoporosis, recent low-trauma hip fracture, and glucocorticoid-induced osteoporosis. Given that Zol is generally well tolerated and very convenient, it is an interesting therapeutic option for aging patients who take multiple oral drugs, who have adherence or gastrointestinal tolerance issues, and who have an indication for oral bisphosphonates. Zol is not recommended for patients with severe renal impairment. Vitamin D deficiency should be corrected before the administration of Zol.
Early experience with Suboxone maintenance therapy in Hungary. [2015]Suboxone (Buprenorphine/naloxone) is a novel drug used in opiate substitution therapy. In Hungary, it was introduced in November 2007. Suboxone is a product for sublingual administration containing the partial mu-receptor agonist buprenorphine and antagonist naloxone in a 4:1 ratio.
Bisphosphonate-related osteonecrosis of the jaws--a case report. [2018]Bisphosphonates are commonly prescribed for the treatment of osteoporosis and bone cancers. These drugs come in both intravenous and oral forms. Because these drugs have become more prevalent, there have been increased reports of bisphosphonate-related osteonecrosis of the jaws (BRONJ). This case presentation focuses on a 50-year-old woman with a 10-year history of monthly Zometa (zoledronic acid) use for treatment of multiple myeloma, resulting in BRONJ with a very unfavorable outcome. Its purpose is to depict how the chronic use of intravenous (i.v.) bisphosphonates can lead to bisphosphonate-related osteonecrosis of the jaw (BRONJ), and to present treatment options, including conservative measures, the dentist may be able to employ in the early phases of the disease, along with the indications for jaw resection. Osteonecrosis of the jaws in association with bisphosphonate therapy is a very serious condition with which all dentists should be familiar. When the osteonecrosis begins, it can be very painful to the patient, difficult to treat, and can lead to very deleterious sequelae.