Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629740
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Post-market Clinical Follow-up Investigation in Healthy Volunteers Measuring Eye Parameters to Verify Performance and Safety of Previct Drugs for Monitoring of Patients in Treatment of Substance Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This is a controlled prospective post-market clinical follow-up study that aims to collect additional data on performance and safety of the CE-marked eHeatlh system Previct Drugs Previct Drugs is intended to be used in treatment of substance use disorder SUD to support and monitor patients treatment The system relies on self-administered eye scanning performed with a mobile phone application where the analysis of the eyes reaction on intake of drug substances gives an indication of different drug substances The clinical data collected in this study is an important step to verify and improve the algorithms of Previct Drugs and to improve the mathematical models for indicating the use of the substances cannabinoids and phenethylamines
Drug intake will in this study be simulated by a controlled single application of commonly used medicines from cannabinoids and phenethylamine
The study will enroll and follow 30 male and female healthy volunteers for participation of approximately 10 days The study will consist of two visits to the clinic and one follow-up telephone call before the participant has completed the study Baseline data will be collected at the first visit on Day 0 including usage of Previct Drugs followed by usage of Previct Drugs in the home environment for about one week At visit 2 on Day 7 the subject will be administered with the medicine heshe has been randomized to and thereafter use Previct Drugs for up to 5 hours A final follow-up telephone call will take place approximately at day 10 before the participant has completed the study
Drug intake will in this study be simulated by a controlled single application of commonly used medicines from cannabinoids and phenethylamine
The study will enroll and follow 30 male and female healthy volunteers for participation of approximately 10 days The study will consist of two visits to the clinic and one follow-up telephone call before the participant has completed the study Baseline data will be collected at the first visit on Day 0 including usage of Previct Drugs followed by usage of Previct Drugs in the home environment for about one week At visit 2 on Day 7 the subject will be administered with the medicine heshe has been randomized to and thereafter use Previct Drugs for up to 5 hours A final follow-up telephone call will take place approximately at day 10 before the participant has completed the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None