Conditions: Opioid Dependency
Keywords: Buprenorphine tablet Fast dissolving tablet Opioid dependant patients
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 52
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Buprenorphine hydrochloride marketed sublingual tablet (Subutex) intervention 2: Buprenorphine hydrochloride fast dissolving tablet (FDT)
Intervention descriptions: intervention 1: 8 mg or 16 mg daily, sublingual route on Days 1 and 2 intervention 2: 8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5

Protocol document: