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

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

Detailed Description
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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.

Official Title
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A Second Explorative Pilot Study Evaluating Usability and Functionality of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With Confirmed Substance Use Disorder (SUD)

Conditions
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Drug Abuse

Intervention / Treatment
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* Device: Previct Drugs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The investigation aims to enroll up to 30 SUD subjects. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined. It is based on available subjects from the clinic.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with confirmed SUD<br>Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD). | Device: Previct Drugs<br>* Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if the user-interface of the mobile phone application Previct Drugs is suitable to be used by patients with substance use disorder. | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. | Up to 4 weeks post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if self-administered pupillometry using a mobile phone application can be used to collect pupillograms for patients with substance use disorder. | The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using native pupillograms. | Up to 4 weeks post baseline | 
| Evaluate if self-administered pupillometry using a mobile phone application, after refining the method for establishing pupillograms and key feature extraction algorithms, can be used to collect pupillograms from patients with substance use disorder. | The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using refined pupillograms and and key feature extraction algorithms. | Up to 4 weeks post baseline |