Clinical trial NCT05737550: An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Lead sponsor: Kontigo Care AB
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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

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.

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

Primary outcomes:
measure: Usability Questionnaire - Question 1.
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 2
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 4
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 6
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 8
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 10
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 12.
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 14.
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 16.
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 17.
timeFrame: Day 0 (Visit 1)
measure: Usability Questionnaire - Question 18.
timeFrame: Day 0 (Visit 1)
Secondary outcomes:
measure: Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder.
timeFrame: Up to 4 weeks post baseline
measure: Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder.
timeFrame: Up to 4 weeks post baseline
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa
state: Uppland
Study officials:
affiliation: Kontigo Care AB
name: Markku Hämäläinen, PhD
role: STUDY_CHAIR
References: