Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00723749
First received: July 25, 2008
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.


Condition Intervention
Opioid-Related Disorders
Opiate Dependence
Drug Abuse
Drug: Buprenorphine/Naloxone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Data From a Real Life Scenario.

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Retention Rate After 12 Months of Treatment With Suboxone [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.


Secondary Outcome Measures:
  • Dosage of SUBOXONE® [ Time Frame: Day 1 and Final Assessment (month 12 or time of dropout) ] [ Designated as safety issue: Yes ]
    Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.

  • Take Home Prescriptions of SUBOXONE® [ Time Frame: Day 1 and Final Assessment (month 12 or time of dropout) ] [ Designated as safety issue: Yes ]

    Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.

    Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.

    A patient can receive only one take home prescription for up to 7 days at the time.


  • Drug Craving (Subjective Effects of Therapy) [ Time Frame: Baseline and Final Assessment (month 12 or time of dropout) ] [ Designated as safety issue: Yes ]
    Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)


Enrollment: 384
Study Start Date: March 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Suboxone
Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Drug: Buprenorphine/Naloxone

Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine & 0.5 mg naloxone and 8 mg buprenorphine & 2 mg naloxone.

The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.

Other Names:
  • SCH 000484
  • SUBOXONE®

Detailed Description:

Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Opioid-dependent patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.

Criteria

Inclusion Criteria:

  • Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Exclusion Criteria:

  • In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723749

Sponsors and Collaborators
Reckitt Benckiser Pharmaceuticals Inc.
Investigators
Principal Investigator: Markus Backmund, PD Dr. med. Praxiszentrum im Tal (pit), Munich (Germany)
  More Information

No publications provided

Responsible Party: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00723749     History of Changes
Other Study ID Numbers: P05603
Study First Received: July 25, 2008
Results First Received: January 11, 2012
Last Updated: April 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: National Association of Statutory Health Insurance Physicians
Germany: Federal Association of Company Health Insurance Fund

Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
Suboxone
Subutex
Buprenorphine
Naloxone

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naloxone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 28, 2014