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

NCT01075971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-04-11

Study results available
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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

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

Sponsors & Collaborators

  • Reckitt Benckiser LLC

    collaborator INDUSTRY

  • Indivior Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2005-11-30
Completion
2005-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01075971 on ClinicalTrials.gov