N/A
N=307
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
Opioid-Related Disorders · Opiate Dependence · Drug Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00725608 ↗Enrolled (actual)
307
Serious AEs
0.6%
Results posted
Mar 2012
Primary outcome: Primary: Retention Rate — 57.3; 45.6 percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- buprenorphine/naloxone (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Indivior Inc.
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Rate |
57.3; 45.6 | — |
| SECONDARY Dosing of Suboxone (Buprenorphine Plus Naloxone) |
7.7; 9.1; 8.5 | — |
| SECONDARY Dispensing of Suboxone (Buprenorphine Plus Naloxone) |
183; 96; 1; 79; 2; 5 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00725608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.