Addiction recovery of opioid dependent patients treated with injectable subcutaneous depot buprenorphine (BUVIDAL®)
Recruiting
- Conditions
- F11.2
- Registration Number
- DRKS00020797
- Lead Sponsor
- niversitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie (W37), Zentrum für Interdisziplinäre Suchtforschung (ZIS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 426
Inclusion Criteria
(1) Opioid dependence (F11.2) according to ICD-10; (2) Minimum age of 18 years; (3) Ability to follow the study conditions; (4) Signed written informed consent.
Exclusion Criteria
(1) Existing contraindications according to the patient's specialist information to use BUVIDAL® (e.g. hypersensitivity to the active substance, severe respiratory failure, severe liver dysfunction, acute alcoholism or delirium tremen); (2) patient already in substitution treatment with BUVIDAL®; (3) Predictable reasons for early dropout (e.g. detention, planned place of residence and change of doctor)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference of OSTQOL total score in depot group between baseline (t0) and month 12 (t4)
- Secondary Outcome Measures
Name Time Method (1) Quality of life (OSTQOL score) between depot and control group at month 12 (t4); (2) Acceptance (TSQM-14) of injectable depot buprenorphine between months 1 (t1) and Month 12 (t4); (3) Patient satisfaction with OST care (CSQ-8) between depot and control group at t1- t4; (4) Dosage adequacy (ODAS) in depot group at t1-t4; (5) Substance use (i.e. self-reporting) between depot and control group at month 6 (t3) and month 12 (t4); (6) Psychological distress (Mini-SCL) between depot and control group at month 12 (t4); (7) Social participation between depot and control group at month 12 (t4); (8) Retention rate (percentage of patients) in depot group at month 6 (t3) and month 12 (t4); (9) Cost-effectiveness (on the basis of quality-adjusted life years (QALYs); EQ-5D) between depot and control group at month 12 (t4); (10) Changes in quality of life domains (OSTQOL subscales) in depot group between baseline (t0) and month 12 (t4);