Primary Objective- Evaluate if 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). Secondary…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
substance use disorder (SUD)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint
- 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.
Secondary outcome
Secondary Endpoints
- For each medicinal product (D1-D4), the fraction of collected pupillometry
data from the mobile phone application at baseline and while under the
influence of D1-D4, which can after refinement be transformed into pre-defined
key features using refined pupillogram.
- For each medicinal product (D1-D4), change in key features from baseline to
the LC-MS/MS verified peak concentration in plasma after administration of
medicinal product at visit 2 using native or refined pupillograms.
- For each medicinal product (D1-D4), analysis and plot the correlation between
key features and plasma concentration over time using native or refined
pupillograms.
- For each medicinal product (D1-D4), change in key features from baseline to 5
hours after administration of medicinal product at visit 2 using native or
refined pupillograms.
- For each medicinal product (D1-D4), test 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 native or
refined pupillograms.
- User-friendliness of Previct Drugs evaluated by the subject at visit 2.
Safety Endpoint
- The incidence and severity of adverse events associated with Previct Drugs.
Background summary
Kontigo Care AB has developed the new eHealth system Previct Drugs that uses a
smartphone camera-based eye measurement, i.e., pupillometry, to be used in
future monitoring and treatment of patients with substance use disorder (SUD).
Previct Drugs contains an app, to be installed on a compatible smartphone and
used for eye measurements, a web-based careportal to be accessed from a
computer by the healthcare professional for administration and access of
registered data, a database for storage, handling, and analysis of reported
data, and an admin portal for customer settings and device registrations.
Compared to other versions of Previct that are available on the market today,
Previct Drugs rely on the same back-end (web-based careportal, database, and
admin portal) whereas the app is amended to conduct a different measurement
than what the other versions of Previct currently do. Hence, most portions of
the Predict Drugs infrastructure are identical to other existing products.
In the version of Previct Drugs to be used in this investigation there will be
some exceptions compared to the future intended version:
- The careportal will only be used for providing a subject access to the app.
- An external computer will be used for the analysis of the collected data from
the app.
- An R&D cloud will be used for storing the data and results after the study is
completed.
- If it is required to use the admin portal during the investigation it will
only be used for tasks such as providing access to the careportal and
registration of the study specific smartphones.
This will be a pre-market, explorative, early feasibility, pilot, controlled
clinical investigation designed to collect initial clinical data on Previct
Drugs. The clinical data collected in this early feasibility study is an
important step in the product development of Previct Drugs as the data is
required for continuing the development of the mathematical models and
algorithms for drug detection.
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 objective
Primary Objective
- Evaluate if 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).
Secondary Objectives
- Evaluate if 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).
- Evaluate if self-administered pupillometry using a mobile phone application
can be used for indicating use of each medicinal product (D1-D4).
- Evaluate the correlation between pupillometric variables and concentration in
plasma over time for each medicinal product D1-D4.
- Evaluate the maximum time after medicine intake D1-D4 when pupillometric
variables differ from baseline.
- Evaluate if a combination of different pupillometric variables can be used
for indicating use of each medicinal product D1-D4.
- Collect usability data to evaluate if the user-interface of Previct Drugs is
suitable to be used by users.
Safety objective
- Evaluate the safety of using the mobile phone application Previct Drugs for
collecting self-administered pupillometry data.
Study design
This first-in-human, explorative, early feasibility, pilot, clinical
investigation aims to collect initial clinical data for Previct Drugs. The
clinical data collected is an important step in the product development of
Previct Drugs as the data is required for continuing the development of the
mathematical models for signal processing and algorithms for drug detection.
The outcome will serve as a basis for finalizing the design of Previct Drugs
after this investigation, and continuous studies in clinically significant
settings prior to CE marking.
An explorative design has been selected as it is a common approach when there
is little or no experience of using a medical device in humans. This
investigation is also an early feasibility study where the design of the
medical device is not finalized, and the data collected as part of the
investigation is required to complete the design.
The endpoints (see section for study parameters below) selected to be evaluated
in this investigation, have been identified as proper ones to receive
preliminary information on the proof of concept of Previct Drugs, its safety,
and the usability of the device.
The investigation will enroll and follow adult male and female healthy
volunteers, i.e., subjects, for collection of baseline data during one week in
the subject*s home environment and thereafter performance of a single
administration of one of the four medicinal products of interest (D1-D4) at the
site in a controlled setting. The investigation population will consist of 48
subjects (12 subjects per arm) fulfilling the eligibility criteria for the
clinical investigation. The dropout rate is estimated to 10%. The subjects will
be recruited in the Netherlands.
Using a healthy volunteer population will make it possible to:
- Collect drug naïve baseline data where the healthy volunteer will be able to
act as his/her own reference.
- Perform a PK/PD-study in a controlled way with up to 5 hours of measurement
after administration of medicinal product to evaluate if Previct Drugs can
detect the drug substances of interest.
Intervention
Visit 1 at the site:
- Scan they eyes with Previct Drugs 6 times (demonstration and training not
included)
- Pregnancy test (urine test) if fertile female
- Drug screening test (urine test)
- Vital signs, e.g., blood pressure, pulse, ECG
At home between visits 1 and 2:
- Scan the eyes with Previct Drugs 3 times/day for 1 week (+/- 2 days)
Visit 2 at the site:
- Pregnancy test (urine test) if fertile female
- Drug screening test (urine test)
- Vital signs, e.g., oxygen saturation, blood pressure, pulse, body temperature
- Scan the eyes with Previct Drugs 22 times (if to be administered medicinal
cannabis, Previct Drugs will be used 24 times)
- Collection of blood samples at 6 occasions (if to be administered with
medicinal cannabis, a 7th blood sample will also be collected)
- Take a single dose of a medicinal product
- Fill out questionnaire
Study burden and risks
This study is for research purposes only and healthy volunteers will not
directly benefit from participating. It is our hope that the results in this
study will benefit future patients, as the data collected is of importance to
complete the development of Previct Drugs after this investigation.
Potential risks when using Previct Drugs are low or non-existing for the user.
The potential relevant risk for the subject related to usage of Previct Drugs
in this study is that the eyes may get irritated. This risk is though assumed
to be low/non-existing.
There are known side effects of the medicinal products administered at visit 2.
As this is an investigation on healthy volunteers where the medicinal product
is to be administered in a single dose, the probability of events which are not
transient is low or non-existing.
The medicinal products to be used in this investigation are all seen as
addictive medicines, and thereof it is a risk of that the subject get addictive
after study participation. This risk is seen as low or non-existing based on
the design and study population.
Påvel Snickares Gränd 12
Uppsala 75320
SE
Påvel Snickares Gränd 12
Uppsala 75320
SE
Listed location countries
Age
Inclusion criteria
1. Male or female healthy volunteers
2. Age 18 to 70 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-study
medical and surgical history and a 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 study 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 after trying maximum three times per measurement)
9. Been informed of the nature, the scope, and the relevance of the clinical
investigation
10. Voluntarily agreed on participation and has duly signed the Informed
Consent Form
Exclusion criteria
1. Participating in another clinical investigation which may affect the study
outcome according to clinical judgement
2. Pregnancy or Lactating
3. Blind
4. Deaf
5. Abnormal ECG (QTc time>450 ms) at enrollment
6. Current or recent history of alcohol misuse assessed by AUDIT where >=6
points for women or >=8 points for men indicates a potential misuse
7. Current or history of psychiatric disorder or drug misuse assessed by
M.I.N.I where the outcome will be based on clinical judgement
8. Any disease or condition that may influence pupillary reflexes based on
clinical judgement
9. Undergone eye surgery that may influence pupillary reflexes based on
clinical judgement
10. Ongoing treatment with medications which may interfere with eye
measurements based on clinical judgement
11. Ongoing treatment with medications which may interfere with any of the
medicinal products to be used
12. History or presence of allergy or serious reaction to the medicinal
products to be used
13. History or presence of cardiovascular disease, e.g., arteriosclerosis,
hypertension, or cor pulmonale
14. History or presence of sleep-related breath disorder
15. History or presence of gastrointestinal disease, e.g., paralytic ileus,
acute abdomen, delayed gastric emptying, or chronic constipation
16. History or presence of pulmonary disease, e.g., acute pulmonary
insufficiency, severe respiratory depression with hypoxia, chronic obstructive
lung disease, or bronchial asthma
17. History or presence of autoimmune neuromuscular disease, e.g., myasthenia
gravis
18. Not able to read or understand the local language
19. Any other condition that as judged by the investigator may make the
follow-up or investigation inappropriate
20. That according to the Declaration of Helsinki is deemed unsuitable for
study enrollment
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05731999 |
| CCMO | NL82581.000.22 |