NCT01075971

Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Dependency

Interventions

Type	Name	Description
DRUG	Buprenorphine hydrochloride marketed sublingual tablet (Subutex)	8 mg or 16 mg daily, sublingual route on Days 1 and 2
DRUG	Buprenorphine hydrochloride fast dissolving tablet (FDT)	8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2010-02-25
• Last updated: 2023-04-11
• Results posted: 2010-04-13