Announcement date: 2021-06-07

The Institute of Psychiatry and Neurology in Warsaw, as a potential Consortium Leader, announces an open recruitment to the Consortium in order to implement a research project in the therapeutic area of ​​treatment of benzodiazepine addiction as part of the Medical Research Agency's competition for non-commercial clinical trials in the area of ​​psychiatry and neurology. Competition number: ABM/2021/2.

Competition regulations: https://abm.gov.pl/pl/konkursy/aktualne-nabory-1/807,Konkurs-na-niekomercyjne-badania-kliniczne-w-psychiatrii-i-neurologii-ABM20212.html

Recruitment to the Consortium is open to institutions that meet the competition regulations, have a team, infrastructure and clinical experience (main or secondary) in the diagnosis and treatment of addiction to benzodiazepines and similar drugs and will be able to ensure the implementation of the project tasks.

The task of the Consortium will be to conduct a randomized, double-blind, parallel-group clinical trial aimed at demonstrating the effectiveness and safety of the medicinal product indicated by the Consortium Leader in a typical and modified detoxification procedure (developed by the Consortium Leader).

In order to implement the project's tasks, we are looking for centers with equipment and experience in performing the following laboratory tests:

• Screening test for the presence of psychoactive substances in urine
• At least a semi-quantitative test enabling the measurement of benzodiazepine concentrations in serum, with parameters comparable to the SBENZ /Cobas Integra 400 plus Roche system (including detection >3ng/ml).
• Access to the method verifying the measurements from point 2, i.e. gas chromatography/mass spectrometry (GC/MS) or liquid chromatography (HPLC) - in the possession of a potential Consortium Member or in cooperation with a specialized laboratory as a subcontractor of the project.

Detailed information about the planned research project can be obtained from Dr. Anna Basińska-Szafrańska, e-mail: basinska@ipin.edu.pl, tel. 22-4582-554 or 22-4582734.

The deadline for registering willingness to participate in the consortium is 14 days from the date of announcement of the recruitment on the website of the Institute of Psychiatry and Neurology in Warsaw, i.e. June 21, 2021.

The notification should include the following information:

– description of the institution's experience in diagnosing and treating addiction to benzodiazepines and other drugs with similar receptor activity (e.g. "Z" drugs), also in conducting clinical research in this area or experience in conducting scientific research in the field of basic and/or clinical research of the system nervous,

– description of the diagnostic and research equipment required to conduct a clinical trial and access to the verification method,

– the proposed researcher, providing his or her contact details.

In the event of a larger number of consortium members than expected in the competition regulations (i.e. more than three), the Institute of Psychiatry and Neurology will select an institution to join the Consortium based on the competition regulations in accordance with the principles of transparency and equal treatment, taking into account the compliance of the potential Consortium member's activities with the declared goals of the Consortium. the contribution of the potential Consortium Member to the achievement of the Consortium's goal, experience in the implementation of research/clinical activities in the treatment (detoxification) of addiction to benzodiazepines and similar drugs.

News about the results of the open recruitment of Consortium Members, including information about the entities selected to serve as Consortium Members, will be announced on the website of the Institute of Psychiatry and Neurology on June 22, 2021.

Applications should be submitted by e-mail to the following address: basinska@ipin.edu.pl; in the title you should write: COMPETITION ABM/2021/2/BZD