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

Indivior Inc.339 enrolled

Overview

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.

Nonprobability sampling was done by invitation to volunteer.

Study Type

OBSERVATIONAL

Enrollment

339

Conditions

Interventions

buprenorphine/naloxone

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: month 6, month 12

Secondary Outcomes

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.

Time frame: 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)