- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00605033
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
September 9, 2016 updated by: Indivior Inc.
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Subutex sublingual tablet 4-24 mg, daily for 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: Assessed by Day 7 of double-blind, double-dummy treatment period.
|
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.
|
Assessed by Day 7 of double-blind, double-dummy treatment period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
January 17, 2008
First Submitted That Met QC Criteria
January 17, 2008
First Posted (Estimate)
January 30, 2008
Study Record Updates
Last Update Posted (Estimate)
October 21, 2016
Last Update Submitted That Met QC Criteria
September 9, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Narcotic-Related Disorders
- Substance-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Naloxone
- Buprenorphine, Naloxone Drug Combination
Other Study ID Numbers
- P04843
- SWiTCH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Opiate Dependence
-
Assistance Publique - Hôpitaux de ParisCompletedOpioid-related Disorders | Opiate Dependence | Opiate Addiction | Opiate AbuseFrance
-
Merck Sharp & Dohme LLCCompletedOpiate Dependence | Substance Dependence | Drug Dependence
-
Beth Israel Medical CenterAstraZenecaTerminatedGeneralized Anxiety Disorder | Comorbid Opiate Dependence in Remission | Status Post Methadone-Maintenance TreatmentUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)Completed
-
Imperial College LondonRecruitingAddiction OpiateUnited Kingdom
-
University of CincinnatiNational Institute on Drug Abuse (NIDA); MaryhavenUnknownHeroin Dependence | Opiate Dependence | Substance DependenceUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedHeroin Dependence | Opiate DependenceUnited States
-
Indivior Inc.CompletedDrug Abuse | Opiate Dependence | Opiate-related Disorders
-
National Institute on Drug Abuse (NIDA)New York MDRUCompletedSubstance-Related Disorders | Heroin DependenceUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedOpiate DependenceUnited States
Clinical Trials on Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
-
Indivior Inc.CompletedDrug Abuse | Opiate Dependence | Opiate-related Disorders
-
Indivior Inc.CompletedOpioid-Related Disorders | Drug Abuse | Opiate DependenceAustria
-
Indivior Inc.CompletedOpioid-Related Disorders | Drug Abuse | Opiate Dependence
-
Indivior Inc.Completed
-
Indivior Inc.Taipei City Psychiatric Center, TaiwanCompleted
-
Merck Sharp & Dohme LLCCompletedOpiate Dependence | Substance Dependence | Drug Dependence
-
Wake Forest University Health SciencesWithdrawn
-
Indivior Inc.CompletedOpioid Related DisorderAustria, Czech Republic, Germany, Sweden
-
Massachusetts General HospitalNot yet recruitingPost-operative PainUnited States
-
Maimonides Medical CenterTerminatedOpioid Use DisorderUnited States