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

NCT06629740 | Completed

• 2 other identifiers: KCClin03NL87202.058.24
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorder (SUD)

Keywords

substance use disorder; post-market clinical follow-up; eye monitoring; smartphone; app

Outcome Measures

Primary Outcomes (1)

• Verify if self-administered eye scanning using a mobile phone application, using native key features (alone or in predefined combination(s)), can indicate use of each medicine (D1-D2).

  For each medicine (D1-D2), changes for each subject in key features (alone or in predefined combination(s)) between baseline at visit 2 and under the influence of D1-D2 at LC-MS/MS defined peak concentration, using native key features. Key feature is defined as a predefined characteristic obtained from an eye measurement such as pupil size or motion of iris position over time.

  Day 7 (+/- 2 days)

Secondary Outcomes (4)

• Verify if self-administered eye scanning using a mobile phone application, after refinement of the method for establishing key features (alone or in predefined combination(s)), can indicate the use of each medicine (D1-D2).

  Day 7 (+/- 2 days)

• Evaluate the first and last time after medicine intake of D1 or D2 when refined key eye features, alone or in predefined combination(s), differ from baseline.

  Day 7 (+/- 2 days)

• Evaluate the difference between refined drug naïve test data collected at the clinic and compared with tests performed in home environment.

  From Day 0 to Day 7 (+ 2 days)

• Evaluate if the refined drug naïve key features (alone or in predefined combination(s)), collected at baseline differs from data collected at peak plasma concentration under the influence of D1-D2 without compensating for intra-individual variation.

  Day 7 (+/- 2 days)

Other Outcomes (1)

• Incidence and severity of adverse events.

  Throughout the study from enrollment until study completion.

Study Arms (2)

Cannabinoid

EXPERIMENTAL

A single administration of cannabinoid where a CE-marked eHealth system will be used before and after intake.

Device: Measurements with a eHealth system

Phenethylamine

EXPERIMENTAL

A single administration of phenethylamine where a CE-marked eHealth system will be used before and after intake.

Device: Measurements with a eHealth system

Interventions

Measurements with a eHealth system DEVICE

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.

Cannabinoid; Phenethylamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy volunteers.
• Age 18 to 55 years.
• BMI between 18.5-30 kg/m2.
• Weight between 50-100 kg.
• Healthy as determined by the investigator or designee based on pre-investigational medical and surgical history, and health examination at enrollment.
• Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and at visit 2 and must agree to use a medically acceptable contraception from enrollment until clinical investigation completion.
• No current drug usage defined as a negative urine drug test at enrollment and at visit 2.
• Able to use Previct Drugs after initial training (defined as successfully performing a test set after trying maximum three times per measurement).
• Voluntarily agrees to participate and has duly singed the Informed Consent Form.

You may not qualify if:

• Participating in another clinical investigation which may affect the clinical investigation outcome according to clinical judgement.
• Previously participated in the KCClin01 investigation.
• Pregnant or lactating.
• Blind and/or deaf.
• Clinically abnormal ECG, according to the investigator. QTcF time above 450 ms at enrollment.
• Resting heart rate above 90 BPM.
• Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse.
• Current or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical 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.
• Ongoing treatment with medications which may interfere with eye measurements based on clinical judgement.
• Ongoing treatment with medications which may interfere with any of the medicinal products to be used.
• History or presence of allergy or serious reaction to the medicinal products to be used.
• History or presence of cardiovascular disease, e.g., arteriosclerosis, hypertension, or cor pulmonale.
• History or presence of sleep-related breath disorder.

Sponsors & Collaborators

• Kontigo Care AB: lead

Study Sites (1)

Leiden University Medical Center (LUMC)

Leiden, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Substance-Related Disorders; Alzheimer Disease

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Markku Hämäläinen, PhD

  Kontigo Care AB

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized into one of two arms for deciding upon which of the two medicines (phenethylamine or cannabinoid) to be administered through a single application at visit 2. The randomization will also take into account which one of three different smartphone brands with the Previct Drugs mobile phone application preinstalled to be used by the subject during the study. The study aims to enroll 30 subjects, 12 subjects in the phenethylamine group and 18 subjects in the cannabinoid group. The dropout rate is estimated to 10%.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: November 1, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 18, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-04

Locations

NL (1)