An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD

Kontigo Care

Status: Completed

Conditions: Drug Abuse

Treatments: Device: Previct Drugs

Study type: Interventional

Funder types: Industry

Identifiers

NCT05737550

KCClin02

Details and patient eligibility

About

This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.

Full description

This second early feasibility study will give valuable information on the usability of Previct Drugs once being used in the intended population, i.e, patients with confirmed Substance Use Disorder (SUD). It will also give valuable information on the feasibility of Previct drugs function to measure pupils and eye movements in this population including evaluating the safety when using the device.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent Form
• Male and female
• A recurrent visitor at Sprututbytesprogrammet in Uppsala defined as visited the clinic within the last three (3) months
• SUD in accordanve with DSM-5 criteria according to investigator/designee judgement
• Age 18 and above
• Negative urine pregnancy test for all fertile women
• Been informed of the nature, the scope, and the relevance of the clinical investigation
• Voluntarily agreed on participation and has duly singed the Informed Consent Form

Exclusion criteria

• Participating in another clinical investigation which may affect the study outcome according to clinical judgement
• Pregnancy or lactating
• Blind
• Deaf
• Any ECG dangerous arrythmia according to the investigator or designee judgement
• Any disease or condition that may influence pupillary reflexes based on clinical judgement
• Undergone eye surgery that may influence pupillary reflexes based on clinical judgement
• Not able to read or understand the local language
• Any planned travel or treatment which will make it impossible to participate according to the investigator or designee
• Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate
• That according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Subjects with confirmed SUD

Experimental group

Description:

Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).

Treatment:

Device: Previct Drugs