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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-04-30

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.

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Detailed Description

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Nonprobability sampling was done by invitation to volunteer.

Conditions

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Opioid-Related Disorders Opiate Dependence Drug Abuse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

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

buprenorphine/naloxone

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Suboxone, SCH 000484

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.