Pilot study on the safety and feasibility of intravenous opioid agonist therapy (OAT) with Hydagelan® (hydromorphone hydrochloride) in Vienna.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Suchthilfe Wien gGmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

17 Feb 2025 → 30 Nov 2025

Decision date (initial)

2025-02-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Suchthilfe Wien gGmbH (monetary support), G.L. Pharma GmbH (material support)

External identifiers

EU CT number

2024-519652-90-01

EudraCT number

2022-002462-32

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The objective is to determine whether
- intravenous opioid agonist therapy with hydromorphone can be
integrated into clinical practice and is safe in this therapeutic setting.
- to include further target groups that have not yet been reached or have
been reached only poorly.
- the offer of intravenous OAT is accepted by patients and staff of the
Suchthilfe Vienna gGmbH.
- the intravenous consumption of "illegal" opioids or opioid-containing
medications prescribed for oral use is reduced.
- the general state of health (somatic/psychological) and the social
situation stabilize.
- a decrease in delinquency is recorded.
- a higher retention rate in treatment can be achieved.

Secondary objectives 1

1. The secondary objectives of the study are to develop a patient-centered care model and to further develop psychosocial services for this patient group.

Conditions and MedDRA coding

Opioid dependence: Opioid dependence is a serious and usually chronic disease that requires treatment, encompasses various psychological and physical dimensions, and is associated with concomitant diseases and increased mortality.

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - Age between 20 and 65 years - Opioid dependence according to ICD-10 diagnostic criteria. - Patient has been on opioid agonist therapy (OAT) for at least one year; otherwise has been on intravenous opioid use for at least one year; - Patients inject at least 5 times per week. - Presence of a consumption pattern that corresponds with the opening hours of the Suchthilfe Wien - Patient demonstrates willingness and ability to adhere to the planned study procedure and schedule. - Signed patient information after informed consent has been given - no planned vacations (more than 1 day per week), surgeries, hospital or prison stays within the next 14 weeks

Exclusion criteria 1

1. - Diagnosis of severe medical or psychiatric illnesses - Pregnancy - Evidence of severe comorbidities with a predicted life expectancy of less than 12 months - Hypersensitivity to hydromorphone or any of the following other ingredients: Sodium chloride, sodium citrate, citric acid monohydrate, water for injections. - Presence of the following contraindications: o severe respiratory depression with hypoxia or elevated carbon dioxide levels in the blood (hypercapnia). o severe chronic obstructive airway disease o Cor pulmonale o Acute abdomen o Paralytic ileus o concomitant administration of monoaminooxidase inhibitors or within 2 weeks of their discontinuation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - Reduction of intravenous opioid use outside the medical setting. - Feasibility of implementation and execution

Secondary endpoints 1

1. - Reduction in co-drug use - Safety of the intervention - Improvement in health status - Retention in treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Suchthilfe Wien gGmbH

Sponsor organisation

Suchthilfe Wien gGmbH

Address

Gumpendorfer Guertel 8, Mariahilf Mariahilf

City

Vienna

Postcode

1060

Country

Austria

Scientific contact point

Organisation

Suchthilfe Wien gGmbH

Contact name

Stephanie Wörter

Public contact point

Organisation

Suchthilfe Wien gGmbH

Contact name

Stephanie Wörter

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications