Drug AbuseNCT05731999
A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication
A study testing Previct Drugs in people with Drug Abuse, run by Kontigo Care AB at 1 site in Netherlands.
Trial summary
This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Previct Drugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Feb 2023to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female healthy volunteers
- Age 18 to 70 years
- BMI between 18.5-30 kg/m2
- Weight between 50-100 kg
- Healthy as determined by the investigator or designee based on pre-study medical and surgical history and a 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 study completion
Show all 10Show fewer
- 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 after trying maximum three times per measurement)
- Been informed of the nature, the scope, and the relevance of the clinical investigation
- Voluntarily agreed on participation and has duly singed the Informed Consent Form
Who cannot join
- Participating in another clinical investigation which may affect the study outcome according to clinical judgement
- Pregnancy or Lactating
- Blind
- Deaf
- Abnormal ECG (QTc time >450 ms) at enrollment
- Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse
Show all 20Show fewer
- 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
- History or presence of gastrointestinal disease, e.g., paralytic ileus, acute abdomen, delayed gastric emptying, or chronic constipation
- History or presence of pulmonary disease, e.g., acute pulmonary insufficiency, severe respiratory depression with hypoxia, chronic obstructive lung disease, or bronchial asthma
- History or presence of autoimmune neuromuscular disease, e.g., myasthenia gravis
- Not able to read or understand the local language
- Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate
- That according to the Declaration of Helsinki is deemed unsuitable for study enrollment
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center (LUMC) Department of Anesthesiology
Leiden, 2333 ZA
About this study
Official title: A First-in-human Explorative Pilot Study in Healthy Volunteers Measuring Eye Parameters With a New Mobile Phone Application for Future Monitoring of Patients in Treatment of Substance Use Disorder
This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.
Read the detailed description
This first study will give valuable information on the feasibility of Previct Drugs function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of a medicinal product. It will also provide information on the usability of the device. Drug intake will in this first investigation be simulated by a controlled single application of commonly therapeutically used medicinal products from the following classes of drugs: phenethylamines (D1), benzodiazepines (D2), cannabinoids (D3), and opioids (D4).
- Conditions
- Drug Abuse
- Being tested
- Previct Drugs
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previct DrugsDevice
Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.
| Study group | Role | What they receive |
|---|---|---|
| Single application of phenethylamines (D1) | Experimental | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines. Receives: Device: Previct Drugs |
| Single application of benzodiazepines (D2) | Experimental | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines. Receives: Device: Previct Drugs |
| Single application of cannabinoids (D3) | Experimental | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids. Receives: Device: Previct Drugs |
| Single application of opioids (D4) | Experimental | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids. Receives: Device: Previct Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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 "Attempt", and the successful transformation is denoted a "Successful attempt".
Measured: Day 7 +/- 2 days (Visit 2)
Secondary outcomes (29)
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).
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 "Attempt", and the successful transformation is denoted a "Successful attempt.
Measured: Day 7 +/- 2 days (Visit 2)
Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms.
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 corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Measured: Day 7 +/- 2 days (Visit 2)
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.
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 features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Measured: Day 7 +/- 2 days (Visit 2)
Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms.
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 corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Measured: Day 7 +/- 2 days (Visit 2)
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.
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 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 corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. Key feature values were missing in a few instances, as shown in the table.
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 1
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
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 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
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 4
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
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 5
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
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 7
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
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 8
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
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 9
User-friendliness of Previct Drugs evaluated by the subject at visit 2.
Question 9. If Yes (to question 8), how often did you have to tilt the mobile against something:
Response options:
- One occasion
- Several occasions
- Most occasions
- All occasions
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 10
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 10. According to you, how many minutes did a test with Previct Drugs take in general? From start to end.
Response options:
- < 5 minutes
- 5-7 minutes
- > 7 minutes
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 11
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 11. Did you receive a notification when it was time for a test with Previct Drugs?
Response options:
- Yes
- Most of the times
- I did not receive any notifications
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 12
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 12. Did you notice any issues during usage of Previct Drugs?
Response options:
- No
- Yes
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 13
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 13. Did you require any assistance from the study personnel (e.g., through phone) during the usage of Previct Drugs?
Response options:
- Yes
- No
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 15
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 15. If Yes (to question 13), how often did you require assistance?
Response options:
- One occasion
- Several occasions
- Most occasions
- All occasions
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 16
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 16. When starting a measurement, how was your experience finding the right conditions to start the measurement?
Response options:
- Very easy
- Easy
- Nor easy or difficult
- Difficult
- Very difficult
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 18
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 18. How did you experience performing a Nystagmus (look to your extreme right and left) test?
Response options:
- Very easy to perform
- Easy to perform
- Nor easy or difficult to perform
- Difficult to perform
- Very difficult to perform
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 20
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 20. According to you, how many minutes did a Nystagmus test take (from starting test until analyzed)?
Response options:
- < 1 minute
- 1-2 minutes
- > 3 minutes
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 21
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 21. How often did you have to redo a Nystagmus test?
Response options:
- No occasion
- One occasion
- Several occasions
- Most occasions
- All occasions
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 23
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 23. In general, how easy is it for you to cross your eyes?
Response options:
- Very easy
- Easy
- Nor easy or difficult
- Difficult
- Very difficult
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 24
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 24. How did you experience performing a Cross Eyes test?
Response options:
- Very easy to perform
- Easy to perform
- Nor easy or difficult to perform
- Difficult to perform
- Very difficult to perform
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 26
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 26. According to you, how many minutes did a Cross Eyes test take (from starting until analyzed)?
Response options:
- < 1 minute
- 1-2 minutes
- > 3 minutes
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 27
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 27. How often did you have to redo a Cross Eyes test?
Response options:
- No occasion
- One occasion
- Several occasions
- Most occasions
- All occasions
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 29
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 29. How did you experience performing a Contraction test?
Response options:
- Very easy to perform
- Easy to perform
- Nor easy or difficult to perform
- Difficult to perform
- Very difficult to perform
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 31
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 31. How was your experience turning your mobile when asked to?
Response options:
- Very easy to perform
- Easy to perform
- Nor easy or difficult to perform
- Difficult to perform
- Very difficult to perform
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 33
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 33. According to you, how many minutes did a Contraction test take (from starting test until analyzed)?
Response options:
- < 1 minute
- 1-2 minutes
- > 3 minutes
Measured: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 34
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 34. How often did you have to redo a Contraction test?
Response options:
- No occasion
- One occasion
- Several occasions
- Most occasions
- All occasions
Measured: Day 7 +/- 2 days (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Feb 2023
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one out of four arms, i.e., single application of either phenethylamines, benzodiazepines, cannabinoids, or opioids. The investigation aims to enroll 11 subjects, i.e., healthy volunteers, per medicinal product group that have completed the clinical investigation until the telephone follow-up call. For four medicinal products, the total will be 44 subjects. In order to take account for a drop-out rate of 10%, 12 subjects will be included per medicinal product group and in total 48 subjects in the clinical investigation. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kontigo Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markku Hämäläinen, PhD, Study chair, Kontigo Care AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731999
- Sponsor's protocol ID
- KCClin01
- Status last verified
- Apr 2025
- First submitted
- 30 Jan 2023
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Explorative Pilot Study in Healthy Volunteers Measuring Eye Parameters With a New Mobile Phone Application for Future Monitoring of Patients in Treatment of Substance Use Disorder
- ClinicalTrials.gov ID
- NCT05731999
- Acronym / sponsor ID
- KCClin01
- Conditions
- Drug Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kontigo Care ABIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.
Detailed description
This first study will give valuable information on the feasibility of Previct Drugs function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of a medicinal product. It will also provide information on the usability of the device. Drug intake will in this first investigation be simulated by a controlled single application of commonly therapeutically used medicinal products from the following classes of drugs: phenethylamines (D1), benzodiazepines (D2), cannabinoids (D3), and opioids (D4).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will be randomized to one out of four arms, i.e., single application of either phenethylamines, benzodiazepines, cannabinoids, or opioids. The investigation aims to enroll 11 subjects, i.e., healthy volunteers, per medicinal product group that have completed the clinical investigation until the telephone follow-up call. For four medicinal products, the total will be 44 subjects. In order to take account for a drop-out rate of 10%, 12 subjects will be included per medicinal product group and in total 48 subjects in the clinical investigation. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined.
| Arm | Type | Receives |
|---|---|---|
| Single application of phenethylamines (D1) | Experimental | Device: Previct DrugsEvaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines. |
| Single application of benzodiazepines (D2) | Experimental | Device: Previct DrugsEvaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines. |
| Single application of cannabinoids (D3) | Experimental | Device: Previct DrugsEvaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids. |
| Single application of opioids (D4) | Experimental | Device: Previct DrugsEvaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female healthy volunteers
- Age 18 to 70 years
- BMI between 18.5-30 kg/m2
- Weight between 50-100 kg
- Healthy as determined by the investigator or designee based on pre-study medical and surgical history and a health examination at enrollment
Key exclusion criteria (20 listed)
- Participating in another clinical investigation which may affect the study outcome according to clinical judgement
- Pregnancy or Lactating
- Blind
- Deaf
- Abnormal ECG (QTc time >450 ms) at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Previct DrugsPrevict Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD. | Device | Single application of benzodiazepines (D2), Single application of cannabinoids (D3), Single application of opioids (D4), Single application of phenethylamines (D1) |
Primary outcome
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).
Time frame: 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 "Attempt", and the successful transformation is denoted a "Successful attempt".
29 secondary outcomes
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).
Time frame: Day 7 +/- 2 days (Visit 2)
Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms.
Time frame: Day 7 +/- 2 days (Visit 2)
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.
Time frame: Day 7 +/- 2 days (Visit 2)
Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms.
Time frame: Day 7 +/- 2 days (Visit 2)
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.
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 1
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 2
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 4
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 5
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 7
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 8
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 9
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 10
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 11
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 12
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 13
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 15
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 16
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 18
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 20
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 21
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 23
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 24
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 26
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 27
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 29
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 31
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 33
Time frame: Day 7 +/- 2 days (Visit 2)
Usability Questionnaire - Question 34
Time frame: Day 7 +/- 2 days (Visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Drug Abuse, Nicotine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markku Hämäläinen, PhD study chair
Kontigo Care AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Previct Drugs in people with Drug Abuse, run by Kontigo Care AB at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Day 7 +/- 2 days (Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.