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Completed

NCT Number: NCT00725608

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

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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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Drug Abuse Mental Disorders Narcotic-Related Disorders Opiate Dependence Substance-Related Disorders

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

(Multiple sites in Austria) => Coordinating CRO: H&P GmbH

Vienna, 1070, Austria

About this study

Nonprobability sampling was done by invitation to volunteer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

buprenorphine/naloxone

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

Other names: Suboxone, SCH 000484

Primary outcomes

  1. Retention Rate

    Time frame: month 6, month 12

    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

Secondary outcomes

  1. Dosing of Suboxone (Buprenorphine Plus Naloxone)

    Time frame: day 1, month 6, month 12

    One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.

  2. Dispensing of Suboxone (Buprenorphine Plus Naloxone)

    Time frame: month 6, month 12

    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)

Sponsors and collaborators

Lead sponsor

Indivior Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 30, 2008
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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