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Drug AbuseNCT05737550

An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD

A study testing Previct Drugs in people with Drug Abuse, run by Kontigo Care AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs. Read more about this study

Who is it for?
Ages 18 years and older
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
24 participants
Where
1 siteSweden
Study dates
10 Mar 2023to 28 Jun 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form
  • Male and female
  • A recurrent visitor at Sprututbytesprogrammet in Uppsala defined as visited the clinic within the last three (3) months
  • SUD in accordanve with DSM-5 criteria according to investigator/designee judgement
  • Age 18 and above
  • Negative urine pregnancy test for all fertile women
  • 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
  • Any ECG dangerous arrythmia according to the investigator or designee judgement
  • Any disease or condition that may influence pupillary reflexes based on clinical judgement
Show all 11Show fewer
  • Undergone eye surgery that may influence pupillary reflexes based on clinical judgement
  • Not able to read or understand the local language
  • Any planned travel or treatment which will make it impossible to participate according to the investigator or designee
  • 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 enrolment

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa

    Uppsala, Uppland, 75323

Other trials in Sweden

About this study

Official title: A Second Explorative Pilot Study Evaluating Usability and Functionality of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With Confirmed Substance Use Disorder (SUD)

This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.

Read the detailed description

This second early feasibility study will give valuable information on the usability of Previct Drugs once being used in the intended population, i.e, patients with confirmed Substance Use Disorder (SUD). It will also give valuable information on the feasibility of Previct drugs function to measure pupils and eye movements in this population including evaluating the safety when using the device.

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 groups in NCT05737550
Study groupRoleWhat they receive
Subjects with confirmed SUDExperimentalEvaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).
Receives: Device: Previct Drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Usability Questionnaire - Question 1.

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 1. Please evaluate the study subject's ability to use the mobile phone?

    Response options:

    • Good
    • Manageable
    • Less good

    Measured: Day 0 (Visit 1)

  2. Usability Questionnaire - Question 2

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 2. How did you perceive the study subject's ability to follow the instructions given by Previct Drugs?

    Response options:

    • Very good
    • Good
    • Either good or bad
    • Difficult
    • Very difficult

    Measured: Day 0 (Visit 1)

  3. Usability Questionnaire - Question 4

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 4. How did the study subject experience to put him/herself in the right position to be able to start a test?

    Response options:

    • Very easy
    • Easy
    • Either easy or difficult
    • Difficult
    • Very difficult

    Measured: Day 0 (Visit 1)

  4. Usability Questionnaire - Question 6

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 6. How would you evaluate the study subject's ability to perform a Cross-eyes test?

    Response options:

    • Very easy
    • Easy
    • Either easy or difficult
    • Difficult
    • Very difficult

    Measured: Day 0 (Visit 1)

  5. Usability Questionnaire - Question 8

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 8. How would you evaluate the study subject's ability to perform a Nystagmus test?

    Response options:

    • Very easy
    • Easy
    • Either easy or difficult
    • Difficult
    • Very difficult

    Measured: Day 0 (Visit 1)

  6. Usability Questionnaire - Question 10

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 10. How would you evaluate the study subject's ability to perform a Contraction Test?

    Response options:

    • Very easy
    • Easy
    • Either easy or difficult
    • Difficult
    • Very difficult

    Measured: Day 0 (Visit 1)

  7. Usability Questionnaire - Question 12.

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 12. How did the study subject experience keeping the phone still during the test?

    Response options:

    • Very easy
    • Easy
    • Either easy or difficult
    • Difficult
    • Very difficult

    Measured: Day 0 (Visit 1)

  8. Usability Questionnaire - Question 14.

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 14. In addition to the basic instructions, did the study subject need additional support performing tests with Previct Drugs?

    Response options:

    • Yes
    • No
    • Partly

    Measured: Day 0 (Visit 1)

  9. Usability Questionnaire - Question 16.

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 16. Was the study subject able to perform the test after receiving additional support?

    Response options:

    • Yes
    • No
    • Partly

    Measured: Day 0 (Visit 1)

  10. Usability Questionnaire - Question 17.

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 17. How many efforts did it take the study subject to perform test with Previct Drugs?

    Response options:

    • 1-2 times
    • 3-4 times
    • More than 4 times

    Measured: Day 0 (Visit 1)

  11. Usability Questionnaire - Question 18.

    Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.

    Question 18. How likely do you think it is that the study subject will be able to perform tests with Previct Drugs without assistance in a home environment?

    Response options:

    • Very likely
    • Likely
    • Neither likely nor unlikely
    • Unlikely
    • Very unlikely

    Measured: Day 0 (Visit 1)

Secondary outcomes (2)

  1. Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder.

    The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using native pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the native pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types.

    Measured: Up to 4 weeks post baseline

  2. Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder.

    The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using refined pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the refined pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types.

    Measured: Up to 4 weeks post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start10 Mar 2023
  3. Primary completion28 Jun 2023
  4. Study completion28 Jun 2023

Resources

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
Not applicable
Intervention model
Single group
Model description
The investigation aims to enroll up to 30 SUD subjects. 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. It is based on available subjects from the clinic.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737550
Sponsor's protocol ID
KCClin02
Status last verified
Jul 2024
First submitted
10 Feb 2023
Last updated
8 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 Sweden.

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 8 inclusion and 11 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 8 Oct 2024. 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 Sweden. 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 8 Oct 2024). 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?

Usability Questionnaire - Question 1. (time frame: Day 0 (Visit 1)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05737550.

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 8 Oct 2024.

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