A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Dependence; Drug Dependence
Intervention: Suboxone, Buprenorphone Hydrochloride + Naloxone, SCH 484 (Drug); Subutex, Buprenorphine Hydrochloride, SCH 28444 (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Summary
Post-marketing commitment to the European Medicines Agency to conduct a prospective,
controlled study of the transfer from Subutex to Suboxone.
Clinical Details
Official title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Primary outcome: Suboxone® is not inferior to Subutex® as measured by response rate by the Day 7 Visit.
Secondary outcome: Percentage of subjects with a drug-free test for opioids and non-opioid substances will be analyzed using the 2 sample t-test.SUI will be analyzed using a mixed model for repeated measures. This model will include treatment, visit, and treatment-by-visit as the fixed effects. The two-sided 95% confidence interval for the treatment difference will be
presented SOWS will be analyzed using the same methods as those for the SUI analyses. Change from baseline of ASI-Lite will be analyzed using the 2-sample t-test Compliance rate will be analyzed using the 2-sample t-test Treatment retention (ie, subjects who attend the study setting according to the study schedule) will be analyzed using the 2-sample t-test. Measure: Time to dose increase, by the number of days until a dose increase was received via Cox's proportional hazards model.
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
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 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.
- HIV-positive subjects with clinical acquired immunodeficiency syndrome (AIDS).
- Subjects treated with generic buprenorphine.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Investigational Site 11, Zagreb 10000, Croatia; Recruiting
Investigational Site 12, Rijeka 51000, Croatia; Recruiting
Investigational Site 13, Zagreb 10090, Croatia; Active, not recruiting
Investigational Site 33, Rodovre 2610, Denmark; Recruiting
Investigational Site 3, Lyon Cedex 3 69437, France; Recruiting
Investigational Site 2, Bagneux 92220, France; Recruiting
Investigational Site 4, Nice Cedex 1 06006, France; Recruiting
Investigational Site 5, Villejuif Cedex 94804, France; Recruiting
Investigational Site 38, Limoges Cedex 87027, France; Recruiting
Investigational Site 31, Arendal 4809, Norway; Recruiting
Investigational Site 26, Koper 6000, Slovenia; Recruiting
Investigational Site 27, Piran 6320, Slovenia; Recruiting
Investigational Site 36, Goteborg 41685, Sweden; Completed
Investigational Site 37, Malmo 21122, Sweden; Completed
Investigational Site 16, Plymouth PY4 6LF, United Kingdom; Recruiting
Additional Information
Starting date: March 2008
Ending date: May 2009
Last updated: January 14, 2009
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