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Eligible individuals with opioid use disorder using fentanyl received a single 4 mg dose of transmucosal buprenorphine followed by the extended-release buprenorphine 300 mg injection after approximately 1 hour.
Buprenorphine extended release 300 mg injection was found to be feasible and well-tolerated for individuals with opioid use disorder (OUD) using fentanyl, according to results of a study published in The American Journal on Addiction. Investigators aimed to determine whether the rapid induction of buprenorphine extended release could be used as induction and maintenance for this patient population.1
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According to the CDC, nearly 71,000 drug overdose deaths in the United States are from synthetic opioids. Synthetic opioids also account for nearly 88% of all deaths from opioid overdoses in 2021, nearly 23 times as many as in 2013. The CDC added that synthetic opioid deaths are being caused by fentanyl, which can include acetylfentanyl, furanylfentanyl, and carfentanil that are all similar chemical structures to fentanyl.2
Investigators included individuals who were seeking treatment for OUD from August 2019 to May 2020 in Berlin, New Jersey. The study included an initiation portion (NCT03993392) and an extension portion (NCT04060654). Individuals were aged 18 years or older, had a history of moderate or severe OUC, were seeking treatment with buprenorphine, and did not have short-acting opioids for at least 6 hours, or long-acting opioids for 24 hours the morning of the first day.1
Initiation Study
Trial Name: SUBLOCADE Rapid Initiation Study
ClinicalTrials.gov Identifier: NCT03993392
Sponsor: Indivior Inc
Completion Date: December 2019
Extention Study
Trial Name: SUBLOCADE Rapid Initiation Extension Study
ClinicalTrials.gov Identifier: NCT04060654
Sponsor: Indivior Inc
Completion Date: May 2020
Fentanyl use was determined by a urine toxicology test on the first day before induction, with rapid urine tests being used to determine morphine, fentanyl, oxycodone, and buprenorphine, throughout the study. The eligible individuals received a single 4 mg dose of transmucosal buprenorphine followed by the extended-release buprenorphine 300 mg injection after approximately 1 hour, according to the study authors. The extension study had 6 monthly injections, with a 6-month follow up.1
There were 24 individuals included in the study who received both transmucosal buprenorphine followed by extended-release buprenorphine. Out of the 24, approximately 71% tested positive for fentanyl. At the day 29 visit, 20 individuals completed the visit and 17 continued into the extension study for a total of 6 months, totally 6 injections. Out of the 12 individuals, 10 were fentanyl positive.1
Investigators found that in those who were fentanyl positive, moderate withdrawal at 14 decreased to mild withdrawal at 7.9 in 6 hours to no active withdrawal at 4.7 in 24 hours. In the fentanyl negative group, baseline of moderate withdrawal at 9.1 decreased to 4.7 at 6 hours and 3.1 at 24 hours, according to the results of the study.1
Twelve hours after extended-release buprenorphine, investigators in both subgroups were in either mild withdrawal or no active withdrawal. None of the individuals experiences severe withdrawal; however, 1 experienced moderately severe withdrawal at 2 to 3 hours after the extended-release buprenorphine injection. Furthermore, 2 individuals received a supplemental 4 mg of transmucosal buprenorphine within 2 hours after the extended-release buprenorphine on day 1. The study authors reported that no individuals had another dose of transmucosal buprenorphine after initiation day.1
The results demonstrated that after the final assessment, all 9 individuals in the fentanyl positive group were negative, with 8 being negative for any opioid use. The study authors said there were no serious adverse events that resulted in study discontinuation. Treatment-related adverse events included injection site bruising, injection site erythema, and drug withdrawal.1
Reference
FDA Approves Eladocagene Exuparvovec-Tneq for Treatment of AADC Deficiency
