Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)

NCT00684073 | Completed Phase 4 Results

• 2 other identifiers: P050942006-006686-17
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.

Conditions

Opiate-related Disorders; Opiate Dependence; Drug Abuse

Keywords

Suboxone; Subutex; Buprenorphine; Naloxone

Outcome Measures

Primary Outcomes (1)

• Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).

  Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"

  Each treatment Day (post-dose on days 1-5)

Study Arms (1)

Subutex®/Suboxone®

EXPERIMENTAL

Subutex® for first two days of study followed by Suboxone® for last 3 days of study

Drug: buprenorphine; Drug: buprenorphine/naloxone

Interventions

buprenorphine DRUG

2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study

Also known as: Subutex®; SCH 028444

Subutex®/Suboxone®

buprenorphine/naloxone DRUG

2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study

Also known as: Suboxone®; SCH 000484

Subutex®/Suboxone®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Subject must be at least (\>=) 18 years of age, of either sex.
• Subject treated for opioid dependence with Subutex® with a stable daily dose between 2 mg and 16 mg daily, for at least 6 months.
• Subject who do not inject/misuse their treatment with Subutex®.
• Subject 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).

You may not qualify if:

• Subject not eligible for treatment with Subutex® or Suboxone® according to the legal drug attachments.
• Subject refusing to take the daily dose of the study medication under control in the center.
• Subject unable to complete the evaluations.
• Women who are pregnant or nursing.
• Subject with a history of hypersensitivity to buprenorphine hydrochloride or naloxone hydrochloride dihydrate or any excipient of Subutex® or Suboxone®.
• Subject with a current evidence of alcohol abuse.
• Subject with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol intoxication or delirium tremens .
• Subject with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
• 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 and monoamine oxidase \[MAO\] inhibitors,
• CYP3A4 inhibitors,
• CYP3A4 inducers.
• Subjects 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 subject safety.
• Subjects who have used any investigational product within 30 days prior to enrollment.

Sponsors & Collaborators

• Indivior Inc.: lead

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Head, Clinical Trials Registry and Results Disclosure Group
• Organization: Schering-Plough

ClinicalTrialsDisclosure@spcorp.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 20, 2023
• Results First Posted: January 1, 2010

Record last verified: 2023-03