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

July 25, 2008
April 26, 2012
March 2008
December 2010   (final data collection date for primary outcome measure)
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.
Retention rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00723749 on ClinicalTrials.gov Archive Site
  • 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)
Circumstances of switching to SUBOXONE® (dosage, frequency of intake, subjective effects Acceptance and tolerance of SUBOXONE® treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Opioid-Related Disorders
  • Opiate Dependence
  • Drug Abuse
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®
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.
Intervention: Drug: Buprenorphine/Naloxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
384
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00723749
P05603
Yes
Reckitt Benckiser Pharmaceuticals Inc.
Reckitt Benckiser Pharmaceuticals Inc.
Not Provided
Principal Investigator: Markus Backmund, PD Dr. med. Praxiszentrum im Tal (pit), Munich (Germany)
Reckitt Benckiser Pharmaceuticals Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP