MedTrace Logo

A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication

NCT06629740 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-04-02

No results posted yet for this study

Summary

This is a post-market clinical follow-up study on an approved CE-marked eHealth system where a mobile phone application is used to measure the pupils and eye measurements to monitor the use of different drug substances. The goal of the study is to collect additional information when using the system and to improve the current models for indicating the use of cannabinoids and phenethylamines.

Drug intake of cannabinoid or phenethylamine will in this study be simulated using two commonly used medicines.

The study will include healthy volunteers where each participant will participate in the study for approximately 10 days. The participant will be using the mobile phone application for about a week, first at the clinic and then in the home environment. After approximately a week the participant will visit the clinic to be administered with the selected medicine whereafter the mobile phone application will be used for up to 5 hours. A final phone call will be taken place at approximately day 10, whereafter the participant has completed the study.

Conditions

  • Substance Use Disorder (SUD)

Interventions

DEVICE

Measurements with a eHealth system

The eHealth system Previct Drugs is a CE marked medical device intended to be used in treatment of substance use disorder (SUD) to support and monitor patients' treatment. Previct Drugs consists of a mobile phone application used to perform self-administered eye-scanning, a web-based careportal used by the caregiver, a database for storage, handling, and analysis of reported data, and an admin portal for the manufacturer to register and administer customers. In this study, Previct Drugs will be used by healthy volunteers for performing measurements before and after intake of a commonly used medicine to simulate drug intake.

Sponsors & Collaborators

  • Kontigo Care AB

    lead INDUSTRY

Principal Investigators

  • Markku Hämäläinen, PhD · Kontigo Care AB

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-03-17
Completion
2025-03-18

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06629740 on ClinicalTrials.gov