Eye-Scanning app could revolutionize addiction monitoring
NCT ID NCT06629740
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This study tests a CE-marked mobile app that scans a person's eyes to detect whether they have used certain drugs. Healthy volunteers will take a common medicine that mimics the effects of cannabis or amphetamines, then use the app to see if the eye measurements change. The goal is to improve the app's ability to monitor drug use in people being treated for substance use disorder.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a mobile phone application (Previct Drugs) that performs eye-scanning to measure pupil and eye parameters
- What this could lead to
- If successful, this could provide a non-invasive, remote way to monitor drug use in people undergoing treatment for substance use disorder.
- What could go wrong
- This is a small, early-stage study in healthy volunteers using simulated drug intake, so results may not translate directly to real-world patients or all substances.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
34 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Mar 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female healthy volunteers. 2. Age 18 to 55 years. 3. BMI between 18.5-30 kg/m2. 4. Weight between 50-100 kg. 5. Healthy as determined by the investigator or designee based on pre-investigational medical and surgical history, and health examination at enrollment. 6. 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. 7. No current drug usage defined as a negative urine drug test at enrollment and at visit 2. 8. Able to use Previct Drugs after initial training (defined as successfully performing a test set after trying maximum three times per measurement). 9. Voluntarily agrees to participate and has duly singed the Informed Consent Form. Exclusion Criteria: 1. Participating in another clinical investigation which may affect the clinical investigation outcome according to clinical judgement. 2. Previously participated in the KCClin01 investigation. 3. Pregnant or lactating. 4. Blind and/or deaf. 5. Clinically abnormal ECG, according to the investigator. QTcF time above 450 ms at enrollment. 6. Resting heart rate above 90 BPM. 7. Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse. 8. Current or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical judgement. 9. Any disease or condition that may influence pupillary reflexes based on clinical judgement. 10. Undergone eye surgery that may influence pupillary reflexes based on clinical judgement. 11. Ongoing treatment with medications which may interfere with eye measurements based on clinical judgement. 12. Ongoing treatment with medications which may interfere with any of the medicinal products to be used. 13. History or presence of allergy or serious reaction to the medicinal products to be used. 14. History or presence of cardiovascular disease, e.g., arteriosclerosis, hypertension, or cor pulmonale. 15. History or presence of sleep-related breath disorder. 16. History or presence of gastrointestinal disease, e.g., paralytic ileus, acute abdomen, delayed gastric emptying, or chronic constipation. 17. History or presence of pulmonary disease, e.g., acute pulmonary insufficiency, severe respiratory depression with hypoxia, chronic obstructive lung disease, or bronchial asthma. 18. History or presence of autoimmune neuromuscular disease, e.g., myasthenia gravis. 19. Not able to read or understand the local language. 20. Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Leiden University Medical Center (LUMC)
Leiden, 2333 ZA, Netherlands
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