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
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
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
Group
Value
95% CI
Single Application of Phenethylamines
5
Single Application of Benzodiazepines
1
Single Application of Cannabinoids
4
Single Application of Opioids
7
500 Lux
Group
Value
95% CI
Single Application of Phenethylamines
5
Single Application of Benzodiazepines
3
Single Application of Cannabinoids
2
Single Application of Opioids
7
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
Group
Value
95% CI
Single Application of Phenethylamines
5
Single Application of Benzodiazepines
6
Single Application of Cannabinoids
7
Single Application of Opioids
10
500 LUX
Group
Value
95% CI
Single Application of Phenethylamines
7
Single Application of Benzodiazepines
4
Single Application of Cannabinoids
2
Single Application of Opioids
9
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
Group
Value
95% CI
Single Application of Phenethylamines
6
Single Application of Benzodiazepines
1
Single Application of Cannabinoids
2
Single Application of Opioids
8
500 LUX
Group
Value
95% CI
Single Application of Phenethylamines
5
Single Application of Benzodiazepines
5
Single Application of Cannabinoids
0
Single Application of Opioids
6
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
Group
Value
95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase
12
Single Application of Phenethylamines - 500 Lux Key Feature Dbase
12
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff
12
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff
10
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
11
Single Application of Cannabinoids - 50 Lux Key Feature MCA
12
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
12
Single Application of Cannabinoids - 500 Lux Key Feature Redness
12
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
11
Single Application of Opioids - 50 Lux Key Feature Dbase
12
Single Application of Opioids - 500 Lux Key Feature Dbase
11
At baseline number of false positive
Group
Value
95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase
0
Single Application of Phenethylamines - 500 Lux Key Feature Dbase
0
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff
0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff
2
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
1
Single Application of Cannabinoids - 50 Lux Key Feature MCA
0
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
0
Single Application of Cannabinoids - 500 Lux Key Feature Redness
0
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
1
Single Application of Opioids - 50 Lux Key Feature Dbase
0
Single Application of Opioids - 500 Lux Key Feature Dbase
0
At baseline, missing key feature data
Group
Value
95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase
0
Single Application of Phenethylamines - 500 Lux Key Feature Dbase
0
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff
0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff
0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
0
Single Application of Cannabinoids - 50 Lux Key Feature MCA
0
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
0
Single Application of Cannabinoids - 500 Lux Key Feature Redness
0
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
0
Single Application of Opioids - 50 Lux Key Feature Dbase
0
Single Application of Opioids - 500 Lux Key Feature Dbase
1
At peak concentration number of true positive
Group
Value
95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase
12
Single Application of Phenethylamines - 500 Lux Key Feature Dbase
12
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff
12
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff
11
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
10
Single Application of Cannabinoids - 50 Lux Key Feature MCA
10
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
11
Single Application of Cannabinoids - 500 Lux Key Feature Redness
8
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
9
Single Application of Opioids - 50 Lux Key Feature Dbase
12
Single Application of Opioids - 500 Lux Key Feature Dbase
11
At peak concentration number of false negative
Group
Value
95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase
0
Single Application of Phenethylamines - 500 Lux Key Feature Dbase
0
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff
0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff
1
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
1
Single Application of Cannabinoids - 50 Lux Key Feature MCA
1
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
0
Single Application of Cannabinoids - 500 Lux Key Feature Redness
3
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
1
Single Application of Opioids - 50 Lux Key Feature Dbase
0
Single Application of Opioids - 500 Lux Key Feature Dbase
0
At peak concentration, missing key feature data
Group
Value
95% CI
Single Application of Phenethylamines - 50 Lux Key Feature Dbase
0
Single Application of Phenethylamines - 500 Lux Key Feature Dbase
0
Single Application of Benzodiazepines - 50 Lux Key Feature NCdiff
0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff
0
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
1
Single Application of Cannabinoids - 50 Lux Key Feature MCA
1
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
1
Single Application of Cannabinoids - 500 Lux Key Feature Redness
0
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
2
Single Application of Opioids - 50 Lux Key Feature Dbase
0
Single Application of Opioids - 500 Lux Key Feature Dbase
1
Usability Questionnaire - Question 1Secondary· 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
Group
Value
95% 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 2Secondary· 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
Group
Value
95% 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 4Secondary· 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
Group
Value
95% 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 5Secondary· 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
Group
Value
95% 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 7Secondary· 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
Group
Value
95% 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 8Secondary· 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
Group
Value
95% 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)
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):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kontigo Care AB
Last refreshed: 2 April 2025
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.