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De klinische studie NCT06316830 (Optimal Bup) voor Opioïdengebruiksstoornis is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose Fase 2, Fase 3 250 Preventie

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De klinische studie NCT06316830 (Optimal Bup) onderzoekt behandeling bij Opioïdengebruiksstoornis. Deze Fase 2 Fase 3 interventioneel-studie heeft de status rekruterend. Het doel is om 250 deelnemers te includeren vanaf 6 januari 2025. De studie wordt geleid door Rhode Island Hospital en de voltooiing is gepland op 1 november 2027. Laatste update op ClinicalTrials.gov: 23 oktober 2025.
Beknopte samenvatting
The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).

The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved ...

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Officiële titel

Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder

Aandoeningen
Opioïdengebruiksstoornis
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • Optimal Bup
  • STUDY00000075
NCT-ID
NCT06316830
Startdatum (Werkelijk)
2025-01-06
Laatste update geplaatst
2025-10-23
Verwachte einddatum
2027-11-01
Inschrijving (Geschat)
250
Studietype
Interventioneel
FASE
Fase 2
Fase 3
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelHigh Maintenance Daily Dose (24mg)
The experimental intervention is a high daily maintenance dose of buprenorphine (24 mg) plus any usual clinical care the participant receives at the clinic. This high daily dose is the upper limit of the FDA-approved dose range and was selected based on preclinical studies, clinician anecdotes, case reports, and retrospective analyses suggesting improved effectiveness of higher buprenorphine doses among patients with...Toon meer
Buprenorphine
Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.
Actieve comparatorStandard Maintenance Daily Dose (16mg)
The control intervention is the FDA-recommended target daily maintenance dose of buprenorphine (16 mg) plus any usual clinical care the participant receives at the clinic.
Buprenorphine
Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Treatment Engagement
The primary outcome is the percentage of participants retained in buprenorphine treatment. Participants will be classified as retained in buprenorphine treatment at six months post- randomization if (1) the study site data indicate that they remained engaged in treatment or (2) the PDMP suggest that they continued treatment elsewhere and have not had a gap of more than 27 days in medication on-hand based on fill dates and days' supply.
six months post-randomization
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Control of Opioid Cravings
Measured using patient reported outcomes via the Opioid Craving Scale, a reliable, validated scale for people with opioid use disorder. The scale consists of three questions related to opioid cravings rated on a scale of 1-10 with 1 being not at all and 10 being extremely. A higher score denotes increased opioid cravings.
six months post-randomization
Treatment response based on use of non-prescribed opioids
Non-prescribed fentanyl and other opioid use will be assessed via urine drug screens including fentanyl (UDS) and self-report. UDS will be assessed monthly for six months after study enrollment. Self-reported will be assessed at 1, 3, and 6 months via a Time Line Followback (TLFB) assessing ongoing non-prescribed opioid/fentanyl over the preceding two weeks. Based on UDS and self-reported data, participants will be classified as treatment responders if they have (1) no evidence (negative UDS and negative self-report) of non-prescribed opioid use at ≥1 assessment in months 1 to 3 AND (2) no evidence of non-prescribed opioid use at ≥2 assessments in months 4 to 6.
six months post-randomization
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • English-speaking
  • Age 18 years-old or older
  • Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
  • Initiating or continuing buprenorphine for treatment of opioid use disorder
  • History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)

  • Previous enrollment in the trial
  • Incarcerated or in police custody*
  • Pregnant
  • Live outside of Rhode Island (RI)
  • Unable to provide informed consent
  • Allergy to Buprenorphine
  • Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician *Participants that become incarcerated/or in police custody during the study will be withdrawn.
Rhode Island Hospital logoRhode Island Hospital
Brown University logoBrown University
Verantwoordelijke instantie
Francesca Beaudoin, Hoofdonderzoeker, Professor of Epidemiology and Emergency Medicine, Rhode Island Hospital
Centraal Contactpersoon
Contact: Jackie Goldman, 401-808-6950, [email protected]
Contact: Rachel Wightman, MD, [email protected]
1 Studielocaties in 1 landen

Rhode Island

Brown University, Providence, Rhode Island, 02912, United States
Jackie Goldman, Contact, 401-808-6950, [email protected]
Francesca Beaudoin, Hoofdonderzoeker
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