CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Buprenorphine Control +3 moredrug
Likely dose
Buprenorphine + Rifampin 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01576575
NCT01576575N/ACompleted

Influence of CYP3A Modulation on Buprenorphine Disposition and Clinical Effects

Washington University School of Medicine·interventional·Posted Apr 12, 2012·Updated Jan 22, 2020

In Brief

A clinical study evaluating Buprenorphine Control, Buprenorphine + Rifampin, and 2 other interventions for Healthy. Completed, enrolled 21 participants across 1 site.

Detailed Summary

To evaluate role of CYP3A in buprenorphine disposition and effect

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2012
Enrollment StartJun 1, 2010
Primary CompletionMar 29, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.2 years ago

Interventions

Buprenorphine Controldrug

Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)

Buprenorphine + Rifampindrug

Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine

Buprenorphine + Grapefruit juicedrug

Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine

Buprenorphine + Ketoconazoledrug

Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine