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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00605033

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 IV

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

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Suboxone® is not inferior to Subutex® as measured by response rate by the Day 7 Visit. [ Time Frame: For the DB-DD treatment period (days 1-7) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects with a drug-free test for opioids and non-opioid substances will be analyzed using the 2 sample t-test. [ Time Frame: week 1, day 15, 22 and day 28 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 to day 8 daily, day 15, day 22 and day 28 ] [ Designated as safety issue: No ]
SOWS will be analyzed using the same methods as those for the SUI analyses. [ Time Frame: Day 1 to day 8 daily, day 15, day 22 and day 28 ] [ Designated as safety issue: No ]
Change from baseline of ASI-Lite will be analyzed using the 2-sample t-test [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
Compliance rate will be analyzed using the 2-sample t-test [ Time Frame: week 1, week 2, week 3 and week 4 ] [ Designated as safety issue: No ]
Treatment retention (ie, subjects who attend the study setting according to the study schedule) will be analyzed using the 2-sample t-test. [ Time Frame: week 1, week 2, week 3 and week 4. ] [ Designated as safety issue: No ]
Measure: Time to dose increase, by the number of days until a dose increase was received via Cox's proportional hazards model. [ Time Frame: week 1 and week 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	March 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Suboxone Active ( plus Subutex Placebo): Active Comparator None	Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 Suboxone sublingual tablet 4-24 mg, daily for 28 days
Subutex Active (plus Suboxone Placebo): Active Comparator None	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 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04843, SWITCH
Study First Received:	January 17, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00605033 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Narcotic Antagonists
Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin

Narcotics
Peripheral Nervous System Agents
Analgesics
Opioid-Related Disorders
Analgesics, Opioid
Naloxone

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 10, 2009