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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2023-06-28

Brief Summary

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

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Detailed Description

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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

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Drug Abuse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Subjects with confirmed SUD

Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).

Group Type EXPERIMENTAL

Previct Drugs

Intervention Type DEVICE

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.

Interventions

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Previct Drugs

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No