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NCT05731999

A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication

Completed NA Results posted Last updated 2 April 2025
What this trial tests

NA trial testing Previct Drugs in Drug Abuse in 48 participants. Completed in 19 July 2023.

Timeline
15 February 2023
Primary endpoint
19 July 2023
19 July 2023

Quick facts

Lead sponsorKontigo Care AB
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment48
Start date15 February 2023
Primary completion19 July 2023
Estimated completion19 July 2023
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Kontigo Care AB

Who can join

Adults 18 to 70, any sex, with Drug Abuse. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). Primary · Day 7 +/- 2 days (Visit 2)

For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Atte

Successful attempts - Non-convergence (NC)
GroupValue95% CI
Single Application of Phenethylamines (D1)295
Single Application of Benzodiazepines (D2)286
Single Application of Cannabinoids (D3)317
Single Application of Opioids (D4)300
Successful attempts - Horizontal nystagmus (NY)
GroupValue95% CI
Single Application of Phenethylamines (D1)279
Single Application of Benzodiazepines (D2)242
Single Application of Cannabinoids (D3)300
Single Application of Opioids (D4)282
Successful attempts - Tremor (TR)
GroupValue95% CI
Single Application of Phenethylamines (D1)295
Single Application of Benzodiazepines (D2)282
Single Application of Cannabinoids (D3)319
Single Application of Opioids (D4)295
Successful attempts - Pupillary light reflex (PLR)
GroupValue95% CI
Single Application of Phenethylamines (D1)290
Single Application of Benzodiazepines (D2)297
Single Application of Cannabinoids (D3)302
Single Application of Opioids (D4)307
Successful attempts - Redness (RED)
GroupValue95% CI
Single Application of Phenethylamines (D1)314
Single Application of Benzodiazepines (D2)317
Single Application of Cannabinoids (D3)312
Single Application of Opioids (D4)325
Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). Secondary · Day 7 +/- 2 days (Visit 2)

For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using refined pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Att

Successful attempts - Non-convergence (NC)
GroupValue95% CI
Single Application of Phenethylamines (D1)296
Single Application of Benzodiazepines (D2)282
Single Application of Cannabinoids (D3)318
Single Application of Opioids (D4)297
Successful attempts - Horizontal nystagmus (NY)
GroupValue95% CI
Single Application of Phenethylamines (D1)281
Single Application of Benzodiazepines (D2)241
Single Application of Cannabinoids (D3)305
Single Application of Opioids (D4)281
Successful attempts - Tremor (TR)
GroupValue95% CI
Single Application of Phenethylamines (D1)295
Single Application of Benzodiazepines (D2)282
Single Application of Cannabinoids (D3)319
Single Application of Opioids (D4)295
Successful attempts - Pupillary light reflex (PLR)
GroupValue95% CI
Single Application of Phenethylamines (D1)294
Single Application of Benzodiazepines (D2)303
Single Application of Cannabinoids (D3)309
Single Application of Opioids (D4)317
Successful attempts - Redness (RED)
GroupValue95% CI
Single Application of Phenethylamines (D1)314
Single Application of Benzodiazepines (D2)317
Single Application of Cannabinoids (D3)312
Single Application of Opioids (D4)325
Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. Secondary · Day 7 +/- 2 days (Visit 2)

For each medicinal product (D1-D4), number of changed key features from baseline to the LC-MS/MS (Liquid Chromatography Tandem Mass-Spectroscopy) verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. Each of the 24 key features represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and peak concentration is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and

50 Lux
GroupValue95% CI
Single Application of Phenethylamines5
Single Application of Benzodiazepines1
Single Application of Cannabinoids4
Single Application of Opioids7
500 Lux
GroupValue95% CI
Single Application of Phenethylamines5
Single Application of Benzodiazepines3
Single Application of Cannabinoids2
Single Application of Opioids7
Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. Secondary · Day 7 +/- 2 days (Visit 2)

For each medicinal product (D1-D4), number of significant correlations between key features and plasma concentration over time using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "correlated" if the slope in a linear regression is significantly different from zero (p\<0.05). The term correlated over time refers to data collected during 5 hours at Visit 2 after administration of D1-D4. Key features were available from two conditions, one condition where pupillograms and corresponding key fea

50 LUX
GroupValue95% CI
Single Application of Phenethylamines5
Single Application of Benzodiazepines6
Single Application of Cannabinoids7
Single Application of Opioids10
500 LUX
GroupValue95% CI
Single Application of Phenethylamines7
Single Application of Benzodiazepines4
Single Application of Cannabinoids2
Single Application of Opioids9
Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. Secondary · Day 7 +/- 2 days (Visit 2)

For each medicinal product (D1-D4), number of changed key features from baseline to 5 hours after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and at 5 hours is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and c

50 LUX
GroupValue95% CI
Single Application of Phenethylamines6
Single Application of Benzodiazepines1
Single Application of Cannabinoids2
Single Application of Opioids8
500 LUX
GroupValue95% CI
Single Application of Phenethylamines5
Single Application of Benzodiazepines5
Single Application of Cannabinoids0
Single Application of Opioids6
Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. Secondary · Day 7 +/- 2 days (Visit 2)

For each medicinal product (D1-D4), evaluate known combinations of key features that changes from baseline to the LC-MS/MS verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A combination of key features collected at peak plasma concentration was used to build a logistic regression classifier, and the resulting counts of true positives, true negatives, false positives, and false negatives are presented. Key features were availa

At baseline number of true negative
GroupValue95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase12
Single Application of Phenethylamines - 500 Lux Key Feature Dbase12
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff12
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff10
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave11
Single Application of Cannabinoids - 50 Lux Key Feature MCA12
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness12
Single Application of Cannabinoids - 500 Lux Key Feature Redness12
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber11
Single Application of Opioids - 50 Lux Key Feature Dbase12
Single Application of Opioids - 500 Lux Key Feature Dbase11
At baseline number of false positive
GroupValue95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase0
Single Application of Phenethylamines - 500 Lux Key Feature Dbase0
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff2
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave1
Single Application of Cannabinoids - 50 Lux Key Feature MCA0
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness0
Single Application of Cannabinoids - 500 Lux Key Feature Redness0
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber1
Single Application of Opioids - 50 Lux Key Feature Dbase0
Single Application of Opioids - 500 Lux Key Feature Dbase0
At baseline, missing key feature data
GroupValue95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase0
Single Application of Phenethylamines - 500 Lux Key Feature Dbase0
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave0
Single Application of Cannabinoids - 50 Lux Key Feature MCA0
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness0
Single Application of Cannabinoids - 500 Lux Key Feature Redness0
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber0
Single Application of Opioids - 50 Lux Key Feature Dbase0
Single Application of Opioids - 500 Lux Key Feature Dbase1
At peak concentration number of true positive
GroupValue95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase12
Single Application of Phenethylamines - 500 Lux Key Feature Dbase12
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff12
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff11
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave10
Single Application of Cannabinoids - 50 Lux Key Feature MCA10
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness11
Single Application of Cannabinoids - 500 Lux Key Feature Redness8
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber9
Single Application of Opioids - 50 Lux Key Feature Dbase12
Single Application of Opioids - 500 Lux Key Feature Dbase11
At peak concentration number of false negative
GroupValue95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase0
Single Application of Phenethylamines - 500 Lux Key Feature Dbase0
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff1
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave1
Single Application of Cannabinoids - 50 Lux Key Feature MCA1
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness0
Single Application of Cannabinoids - 500 Lux Key Feature Redness3
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber1
Single Application of Opioids - 50 Lux Key Feature Dbase0
Single Application of Opioids - 500 Lux Key Feature Dbase0
At peak concentration, missing key feature data
GroupValue95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase0
Single Application of Phenethylamines - 500 Lux Key Feature Dbase0
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave1
Single Application of Cannabinoids - 50 Lux Key Feature MCA1
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness1
Single Application of Cannabinoids - 500 Lux Key Feature Redness0
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber2
Single Application of Opioids - 50 Lux Key Feature Dbase0
Single Application of Opioids - 500 Lux Key Feature Dbase1
Usability Questionnaire - Question 1 Secondary · Day 7 +/- 2 days (Visit 2)

User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 1. How would you grade the instructions for use? Response options: * Not understandable * Could only understand some parts * Could understand most parts * Could understand almost every part * Fully understandable

GroupValue95% CI
Healthy Volunteers With Single Application of Phenethylamines (D1)0
Healthy Volunteers With Single Application of Benzodiazepines (D2)0
Healthy Volunteers With Single Application of Cannabinoids (D3)0
Healthy Volunteers With Single Application of Opioids (D4)0
Healthy Volunteers With Single Application of Phenethylamines (D1)0
Healthy Volunteers With Single Application of Benzodiazepines (D2)0
Healthy Volunteers With Single Application of Cannabinoids (D3)0
Healthy Volunteers With Single Application of Opioids (D4)0
Healthy Volunteers With Single Application of Phenethylamines (D1)0
Healthy Volunteers With Single Application of Benzodiazepines (D2)1
Healthy Volunteers With Single Application of Cannabinoids (D3)0
Healthy Volunteers With Single Application of Opioids (D4)0
Healthy Volunteers With Single Application of Phenethylamines (D1)1
Healthy Volunteers With Single Application of Benzodiazepines (D2)5
Healthy Volunteers With Single Application of Cannabinoids (D3)5
Healthy Volunteers With Single Application of Opioids (D4)3
Usability Questionnaire - Question 2 Secondary · Day 7 +/- 2 days (Visit 2)

User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 2. Was Previct Drugs easy to use correctly based on the information in the Instructions For Use (IFU)? Response options: * Yes * No

GroupValue95% CI
Healthy Volunteers With Single Application of Phenethylamines (D1)11
Healthy Volunteers With Single Application of Benzodiazepines (D2)12
Healthy Volunteers With Single Application of Cannabinoids (D3)12
Healthy Volunteers With Single Application of Opioids (D4)12
Healthy Volunteers With Single Application of Phenethylamines (D1)1
Healthy Volunteers With Single Application of Benzodiazepines (D2)0
Healthy Volunteers With Single Application of Cannabinoids (D3)0
Healthy Volunteers With Single Application of Opioids (D4)0
Usability Questionnaire - Question 4 Secondary · Day 7 +/- 2 days (Visit 2)

User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 4. How did you experience the verbal instructions during a test with Previct Drugs? Response options: * Very easy to understand * Easy to understand * Nor easy or difficult to understand * Difficult to understand * Very difficult to understand

GroupValue95% CI
Healthy Volunteers With Single Application of Phenethylamines (D1)11
Healthy Volunteers With Single Application of Benzodiazepines (D2)8
Healthy Volunteers With Single Application of Cannabinoids (D3)5
Healthy Volunteers With Single Application of Opioids (D4)6
Healthy Volunteers With Single Application of Phenethylamines (D1)1
Healthy Volunteers With Single Application of Benzodiazepines (D2)4
Healthy Volunteers With Single Application of Cannabinoids (D3)7
Healthy Volunteers With Single Application of Opioids (D4)6
Healthy Volunteers With Single Application of Phenethylamines (D1)0
Healthy Volunteers With Single Application of Benzodiazepines (D2)0
Healthy Volunteers With Single Application of Cannabinoids (D3)0
Healthy Volunteers With Single Application of Opioids (D4)0
Healthy Volunteers With Single Application of Phenethylamines (D1)0
Healthy Volunteers With Single Application of Benzodiazepines (D2)0
Healthy Volunteers With Single Application of Cannabinoids (D3)0
Healthy Volunteers With Single Application of Opioids (D4)0
Usability Questionnaire - Question 5 Secondary · Day 7 +/- 2 days (Visit 2)

User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 5. Before starting a test, the App prompted you with a few written instructions. Did you read the instructions? Response options: * Yes * No

GroupValue95% CI
Healthy Volunteers With Single Application of Phenethylamines (D1)12
Healthy Volunteers With Single Application of Benzodiazepines (D2)10
Healthy Volunteers With Single Application of Cannabinoids (D3)9
Healthy Volunteers With Single Application of Opioids (D4)11
Healthy Volunteers With Single Application of Phenethylamines (D1)0
Healthy Volunteers With Single Application of Benzodiazepines (D2)2
Healthy Volunteers With Single Application of Cannabinoids (D3)3
Healthy Volunteers With Single Application of Opioids (D4)1
Usability Questionnaire - Question 7 Secondary · Day 7 +/- 2 days (Visit 2)

User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 7. How did you experience performing a test with Previct Drugs (from opening of the App until the test was completed)? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform

GroupValue95% CI
Healthy Volunteers With Single Application of Phenethylamines (D1)5
Healthy Volunteers With Single Application of Benzodiazepines (D2)5
Healthy Volunteers With Single Application of Cannabinoids (D3)5
Healthy Volunteers With Single Application of Opioids (D4)4
Healthy Volunteers With Single Application of Phenethylamines (D1)7
Healthy Volunteers With Single Application of Benzodiazepines (D2)5
Healthy Volunteers With Single Application of Cannabinoids (D3)5
Healthy Volunteers With Single Application of Opioids (D4)8
Healthy Volunteers With Single Application of Phenethylamines (D1)0
Healthy Volunteers With Single Application of Benzodiazepines (D2)2
Healthy Volunteers With Single Application of Cannabinoids (D3)2
Healthy Volunteers With Single Application of Opioids (D4)0
Healthy Volunteers With Single Application of Phenethylamines (D1)0
Healthy Volunteers With Single Application of Benzodiazepines (D2)0
Healthy Volunteers With Single Application of Cannabinoids (D3)0
Healthy Volunteers With Single Application of Opioids (D4)0
Usability Questionnaire - Question 8 Secondary · Day 7 +/- 2 days (Visit 2)

User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 8. During a test with Previct Drugs, did you at any time have to tilt the mobile against something to be able to perform a measurement? Response options: * Yes * No

GroupValue95% CI
Healthy Volunteers With Single Application of Phenethylamines (D1)4
Healthy Volunteers With Single Application of Benzodiazepines (D2)3
Healthy Volunteers With Single Application of Cannabinoids (D3)4
Healthy Volunteers With Single Application of Opioids (D4)4
Healthy Volunteers With Single Application of Phenethylamines (D1)8
Healthy Volunteers With Single Application of Benzodiazepines (D2)9
Healthy Volunteers With Single Application of Cannabinoids (D3)8
Healthy Volunteers With Single Application of Opioids (D4)8

Adverse events — posted to ClinicalTrials.gov

Time frame: From signed informed consent to study completion, an average of 10 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Healthy Volunteers With Single Application of Phenethylamines (D1)
Serious: 0/12 (0%)
Deaths: 0/48
Healthy Volunteers With Single Application of Benzodiasepines (D2)
Serious: 0/12 (0%)
Deaths: 0/12
Healthy Volunteers With Single Application of Cannabinoids (D3)
Serious: 0/12 (0%)
Deaths: 0/12
Healthy Volunteers With Single Application of Opioids (D4)
Serious: 0/12 (0%)
Deaths: 0/12
Other adverse events (7 terms — click to expand)

ReactionSystemHealthy Volunteers With Si…Healthy Volunteers With Si…Healthy Volunteers With Si…Healthy Volunteers With Si…
NauseaNervous system disorders
SleepinessInvestigations
Double visionEye disorders
Light headed, dizzyNervous system disorders
VomitingGastrointestinal disorders
Vasovagal reactionNervous system disorders
HeadacheNervous system disorders

Data from ClinicalTrials.gov NCT05731999 adverse events section.

Sponsor's own description

This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Eye reactions under the influence of drugs of abuse as measured by smartphones: a controlled clinical study in healthy volunteers.
    Kuijpers KWK, Andersson K, Winkvist M, Niesters M, et al · · 2024 · cited 4× · PMID 39840007 · DOI 10.3389/fnins.2024.1492246
  2. Opioid Detection Using Smartphone-Based Eye-Scanning.
    Kuijpers KWK, Andersson K, Dahan A, Hämäläinen MD, et al · · 2025 · PMID 40942896 · DOI 10.3390/s25175467
  3. Detecting benzodiazepine use through induced eye convergence inability with a smartphone app: a proof-of-concept study.
    Kuijpers KWK, Hämäläinen MD, Zetterström A, Winkvist M, et al · · 2025 · PMID 40520217 · DOI 10.3389/fdgth.2025.1584716

Verify or expand the search:

Other trials of Previct Drugs

Trials testing the same drug.

Other recruiting trials for Drug Abuse

Currently open trials in the same condition.

Other Kontigo Care AB trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05731999.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing