N/A
Completed N=345
Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
Opioid-Related Disorders · Opiate Dependence · Drug Abuse
Source: ClinicalTrials.gov NCT00723749 ↗
Enrolled (actual)
345
Serious AEs
2.6%
Results posted
Apr 2012
Primary outcomePrimary: Retention Rate After 12 Months of Treatment With Suboxone — 59.9 % of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Rate After 12 Months of Treatment With Suboxone |
59.9 | — |
| SECONDARY Dosage of SUBOXONE® |
9.2; 7.7 | — |
| SECONDARY Take Home Prescriptions of SUBOXONE® |
28; 82 | — |
| SECONDARY Drug Craving (Subjective Effects of Therapy) |
32.3; 7.1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00723749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.