A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00605033
First received: January 17, 2008
Last updated: April 14, 2011
Last verified: September 2010
  Purpose

Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.


Condition Intervention Phase
Opiate Dependence
Drug Dependence
Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Assessed by Day 7 of double-blind, double-dummy treatment period. ] [ Designated as safety issue: No ]
    Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.


Enrollment: 241
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Suboxone
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2.
Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days
Active Comparator: Subutex
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2.
Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444
Subutex sublingual tablet 4-24 mg, daily for 28 days

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be males or non-pregnant, non-lactating females.
  • Subjects must be at least 15 years of age, of either sex, and any race.
  • Subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
  • Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(18) for opioid dependence.
  • Subjects must have been receiving maintenance treatment with Subutex at doses ranging from 4 mg to the maximum dose permitted by country labeling requirements, but not to exceed 24 mg/day, for at least 1 month prior to screening.
  • Subjects must not, according to self-report, have injected opioids more than four times in the month prior to screening.
  • Subjects must have an opioid-negative urine drug screening (UDS) result prior to randomization.
  • Each subject must confirm that he or she is practicing adequate contraception.
  • Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (β-hCG) test prior to enrollment in the study.

Exclusion Criteria:

  • Subjects for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling.
  • Subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
  • Subjects who are participating in any other clinical study in which medication(s) are being delivered.
  • Subjects with known allergy or sensitivity to naloxone.
  • Subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
  • Subjects must not have serious untreated Axis I DSM-IV-TR psychiatric comorbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). Polysubstance abuse or dependence will not exclude subjects except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification.
  • Human immunodeficiency virus (HIV)-positive subjects with clinical acquired immunodeficiency syndrome (AIDS).
  • Subjects treated with generic buprenorphine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00605033     History of Changes
Other Study ID Numbers: P04843, SWITCH
Study First Received: January 17, 2008
Results First Received: May 27, 2010
Last Updated: April 14, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 28, 2014