Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
This study has been completed.
Sponsor:
Reckitt Benckiser Pharmaceuticals Inc.
Information provided by (Responsible Party):
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00725608
First received: July 25, 2008
Last updated: April 26, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.
| Condition | Intervention |
|---|---|
|
Opioid-Related Disorders Opiate Dependence Drug Abuse |
Drug: buprenorphine/naloxone |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing |
Resource links provided by NLM:
Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:
Primary Outcome Measures:
- Retention Rate [ Time Frame: month 6, month 12 ] [ Designated as safety issue: No ]The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study
Secondary Outcome Measures:
- Dosing of Suboxone (Buprenorphine Plus Naloxone) [ Time Frame: day 1, month 6, month 12 ] [ Designated as safety issue: No ]One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.
- Dispensing of Suboxone (Buprenorphine Plus Naloxone) [ Time Frame: month 6, month 12 ] [ Designated as safety issue: No ]Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)
| Enrollment: | 339 |
| Study Start Date: | May 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
Drug: buprenorphine/naloxone
2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for up to 12 months
Other Name: Suboxone, SCH 000484
|
Detailed Description:
Nonprobability sampling was done by invitation to volunteer.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients on substitution therapy for opioid dependence willing to switch to Suboxone
Criteria
Inclusion Criteria:
- All patients on substitution therapy, that are willing to switch to Suboxone, can be included.
- Therapeutic indications and contraindications for Suboxone® must be taken into consideration when selecting patients.
Exclusion Criteria:
- According to product information
- In accordance with the product information pregnant women will be excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725608
Locations
| Austria | |
| (Multiple sites in Austria) => Coordinating CRO: H&P GmbH | |
| Vienna, Austria, 1070 | |
Sponsors and Collaborators
Reckitt Benckiser Pharmaceuticals Inc.
Investigators
| Principal Investigator: | Gabriele Fischer, Prof. Dr. | Medical University Vienna |
More Information
No publications provided
| Responsible Party: | Reckitt Benckiser Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00725608 History of Changes |
| Other Study ID Numbers: | P05444 |
| Study First Received: | July 25, 2008 |
| Results First Received: | October 18, 2011 |
| Last Updated: | April 26, 2012 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
|
Suboxone Subutex Buprenorphine Naloxone |
Additional relevant MeSH terms:
|
Substance-Related Disorders Opioid-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid Naloxone Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013