N/A
Completed N=24
An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD
Drug Abuse
Source: ClinicalTrials.gov NCT05737550 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Usability Questionnaire - Question 1. — 16; 7; 1 Participants
Summary
This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability Questionnaire - Question 1. |
16; 7; 1 | — |
| PRIMARY Usability Questionnaire - Question 2 |
5; 11; 6; 2; 0 | — |
| PRIMARY Usability Questionnaire - Question 4 |
2; 12; 3; 4; 3 | — |
| PRIMARY Usability Questionnaire - Question 6 |
4; 9; 3; 6; 2 | — |
| PRIMARY Usability Questionnaire - Question 8 |
10; 7; 3; 3; 0 | — |
| PRIMARY Usability Questionnaire - Question 10 |
5; 8; 2; 5; 3 | — |
| PRIMARY Usability Questionnaire - Question 12. |
3; 15; 2; 2; 1 | — |
| PRIMARY Usability Questionnaire - Question 14. |
10; 14; 0 | — |
| PRIMARY Usability Questionnaire - Question 16. |
8; 1; 1 | — |
| PRIMARY Usability Questionnaire - Question 17. |
19; 4; 1 | — |
| PRIMARY Usability Questionnaire - Question 18. |
8; 8; 4; 3; 1 | — |
| SECONDARY Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. |
40; 23; 39; 79; 84 | — |
| SECONDARY Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. |
40; 23; 39; 79; 84 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT05737550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.