Trial document




drksid header

  DRKS00020797

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ARIDE

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.aride-studie.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this non-interventional treatment study is to evaluate the effects of the injectable depot-buprenorphine (BUVIDAL®) on the quality of life of patients under routine care conditions.
Secondary target criteria are the acceptance of depot-buprenorphine from the patient's point of view, patient satisfaction with the substitution treatment, appropriateness of the buprenorphine dosage from the patient's point of view, further substance use, the psychological burden from the patient's point of view, social participation from the patient's point of view, retention in the treatment with depot-buprenorphine and the cost-effectiveness.
The primary and secondary target criteria are selected to provide an overall evaluation of the addiction rehabilitation (recovery) in opioid addicts in treatment with injectable depot buprenorphine (BUVIDAL®). To control the effects, the primary and secondary targets will be recorded in a matched control group (substitution treatment with other opioids).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Only about 2-10% of OST patients in Germany regularly terminate OST with opioid abstinence (Nordt et al., 2004, Wittchen et al., 2011; Zippel-Schultz et al., 2016, Verthein et al., 2017) and the health and social burden of patients remains high even after years of OST (Wittchen et al., 2011; Zippel-Schultz et al., 2016; Strada et al., under review). Given the wide-ranging health and social impact of opioid dependence and the limitation of traditional health parameters to reflect the complexity and severity of the condition, patient-related outcome measures (PROMs) such as quality of life are needed to expand the holistic and integrative approach of OST (Zubaran & Foresti, 2009; DeMaeyer et al., 2010; Laudet, 2011) and to strengthen addiction recovery within OST (White et al., 2012).
The sustained release of the newly approved once-weekly or once-monthly injectable depot buprenorphine formulations (BUVIDAL®) have shown to produce an immediate and sustained opioid blockade and to suppress efficiently opioid withdrawal after the first injection (Haasen et al., 2017; Walsh et al., 2017). A pharmacokinetic evaluation has confirmed clinically relevant plasma concentrations of buprenorphine without daily peaks and therefore the potential benefits of injectable depot buprenorphine in the avoidance of withdrawal symptoms (Albayaty et al., 2017). Accordingly, patients reported a higher acceptability of injectable depot buprenorphine than for the sublingual formulation (Albayaty et al., 2017).
The long-acting formulation together with pharmacokinetic profiles and the high tolerability and acceptance reported by patients indicate that injectable depot buprenorphine can have beneficial implications on the patients’ adherence as well as quality of life (Albayaty et al., 2017). Further, the weekly or monthly administration of injectable depot buprenorphine provides new opportunities for medical and psychosocial interventions towards addiction recovery. This research project is a non-interventional, non-randomized, prospective observational study with control group design. The aim of the study is to evaluate the effects of injectable depot buprenorphine on the quality of life of patients under routine care conditions.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

The study protocol will be published in an "open access" journal. After publication of the main publication, anonymized data can be made available to other researchers on request ans only for further research purposes. The study group reserves its right to examine applications appropriately and to reject them if necessary.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00020797
  •   2020/03/06
  •   [---]*
  •   yes
  •   Approved
  •   PV7078, Ethik-Kommission der Ärztekammer Hamburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F11.2 -  Mental and behavioural disorders due to use of opioids; Dependence syndrome
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients on opioid substitution with injectable depot buprenorphine
  •   Patients on opioid substitution with other approved substitutes. Patients are recruited from the same test centers based on matching criteria (gender, duration of substitution treatment, take-home allocation, GAF score).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   IV
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

(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);

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/04/01
  •   426
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie (W37), Zentrum für Interdisziplinäre Suchtforschung (ZIS)
    • Mr.  Dr.  Bernd  Schulte 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie (W37), Zentrum für Interdisziplinäre Suchtforschung (ZIS)
    • Mr.  Dr.  Bernd  Schulte  
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie (W37), Zentrum für Interdisziplinäre Suchtforschung (ZIS)
    • Mr.  Dr.  Bernd   Schulte 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Camurus AB
    • Mr.  Prof. Dr.  Peter  Hjelmström 
    • Sölvegatan 41
    • SE-22370  Lund
    • Sweden
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.