Addiction recovery of opioid dependent patients treated with injectable subcutaneous depot buprenorphine (BUVIDAL®)

Addiction recovery of opioid dependent patients treated with injectable subcutaneous depot buprenorphine (BUVIDAL®) - ARIDE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020797

Enrollment

426

Registered

2020-03-06

Start date

2020-04-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F11.2

Interventions

Group 1: Patients on opioid substitution with injectable depot buprenorphine Group 2: Patients on opioid substitution with other approved substitutes. Patients are recruited from the same test centers

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Difference of OSTQOL total score in depot group between baseline (t0) and month 12 (t4)	—

Secondary

Measure	Time frame
(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);	—

Measure

Time frame

(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);

—

Countries

Germany

Contacts

Public ContactBernd Schulte

Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie (W37), Zentrum für Interdisziplinäre Suchtforschung (ZIS)

b.schulte@uke.de040741059438

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 16, 2026