CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Buprenorphine hydrochloride marketed sublingual tablet (Subutex) +1 moredrug
Likely dose
Buprenorphine hydrochloride marketed sublingual tablet (Subutex) 8 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/NCT01075971
NCT01075971Phase 2Completed
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Evaluation of Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine Maintenance Therapy

Indivior Inc.·interventional·Posted Feb 25, 2010·Updated Apr 11, 2023

In Brief

A Phase 2 clinical trial evaluating Buprenorphine hydrochloride marketed sublingual tablet (Subutex) and Buprenorphine hydrochloride fast dissolving tablet (FDT) for Opioid Dependency. Completed, enrolled 52 participants.

Detailed Summary

This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy. The objectives of this study are to evaluate the overall preference between two buprenorphine sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily maintenance therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependency
Countries--
CollaboratorsReckitt Benckiser LLC

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2010
Enrollment StartSep 1, 2005
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.4 years ago

Interventions

Buprenorphine hydrochloride marketed sublingual tablet (Subutex)drug

8 mg or 16 mg daily, sublingual route on Days 1 and 2

Buprenorphine hydrochloride fast dissolving tablet (FDT)drug

8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5