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

Indivior

Status: Completed

Conditions: Opiate Dependence; Opioid-Related Disorders; Drug Abuse

Treatments: Drug: buprenorphine/naloxone

Study type: Observational

Funder types: Industry

Identifiers

NCT00725608

P05444

Details and patient eligibility

About

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.

Full description

Nonprobability sampling was done by invitation to volunteer.

Enrollment: 339 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

339 participants in 1 patient group

Patients

Description:

Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)

Treatment:

Drug: buprenorphine/naloxone