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

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 Overview

• Status: Completed
• Conditions: Opioid Dependency
• Intervention / Treatment: Drug: Buprenorphine hydrochloride marketed sublingual tablet (Subutex); Drug: Buprenorphine hydrochloride fast dissolving tablet (FDT)

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Patients must be at least (≥) 18 years of age, of either sex.
• Patients treated for opioid dependence with Subutex®, with a stable dosage of 8 mg or 16 mg daily, and respecting the legal drug attachments.
• Patients must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications / products and adverse events to the investigator or designee.
• Women of childbearing potential (includes women who are less than one year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterile (e.g., hysterectomy or tubal ligation).
• Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
• Women of childbearing potential must have a urine pregnancy test with negative result within 2 weeks prior to inclusion (as performed under control of the investigator or designee).

Exclusion Criteria:

• Patients refusing to take the daily dose of the study medication under control in the center.
• Patients unable to complete the evaluations.
• Women who are pregnant or nursing.
• Patients with a history of hypersensitivity to buprenorphine hydrochloride or any excipient of one of its formulations.
• Patients with a current evidence of alcohol abuse.
• Patients with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol intoxication or delirium tremens.

• Initiation or increase in the dose, within the past 7 days or scheduled during the study, of a treatment with:

  • benzodiazepines,
  • other depressants of the central nervous system: other morphine derivatives (analgesics, antitussives), certain antidepressive agents, sedative H1 antihistamines, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, neuroleptics, clonidine and clonidine-like agents,
  • monoamine oxydase [MAO] inhibitors.
• Patients who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematological, gastrointestinal, hepatic, renal, psychiatric, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect patient safety.
• Patients who have used any investigational product within 30 days prior to enrollment.
• Patients participating in another trial at the same time.
• Patients intending to donate blood during the study or within 3 months after study completion.
• Patients in the exclusion period of the "Fichier National des personnes qui se prêtent à des recherches biomédicales sans bénéfice individuel direct" (National Index of persons participating in biomedical researches without direct individual benefit, or National Index of volunteers).
• Patients without Social Security number, or whose maximum annual compensation (3,800 €) has been exceeded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buprenorphine hydrochloride	Drug: Buprenorphine hydrochloride marketed sublingual tablet (Subutex); 8 mg or 16 mg daily, sublingual route on Days 1 and 2; Other Names: Subutex®; Drug: Buprenorphine hydrochloride fast dissolving tablet (FDT); 8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from "Not at all satisfied" (score = 0) to "Totally satisfied" (score = 10).	Daily, Day 1 to Day 5

Collaborators and Investigators

• Sponsor: Indivior Inc.
• Collaborators: Reckitt Benckiser LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Buprenorphine tablet; Fast dissolving tablet; Opioid dependant patients
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: P04451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No