Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

Study Overview
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Brief Summary
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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.

Detailed Description
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Nonprobability sampling was done by invitation to volunteer.

Official Title
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Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing

Conditions
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Opioid-Related Disorders, Opiate Dependence, Drug Abuse

Intervention / Treatment
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* Drug: buprenorphine/naloxone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone) | Drug: buprenorphine/naloxone<br>* 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<br>* Other names: Suboxone, SCH 000484;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate | 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 | month 6, month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing of Suboxone (Buprenorphine Plus Naloxone) | One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose. | day 1, month 6, month 12 | 
| Dispensing of Suboxone (Buprenorphine Plus Naloxone) | 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) | month 6, month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suboxone, Subutex, Buprenorphine, Naloxone