A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication

NCT06629740

Substance Use Disorder (SUD)

COMPLETED NA

Measuring Acute Drug Demand in Humans

NCT05829655

Opioid Use Disorder Opioid Dependence

RECRUITING EARLY_PHASE1

Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment

NCT03994926

Cannabis Intoxication

TERMINATED EARLY_PHASE1

Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans

NCT02323048

Substance Abuse

COMPLETED NA

PHAST: Physical Activity in Substitution Therapy

NCT02309021

Substance-related Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Drug Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to one out of four arms, i.e., single application of either phenethylamines, benzodiazepines, cannabinoids, or opioids. The investigation aims to enroll 11 subjects, i.e., healthy volunteers, per medicinal product group that have completed the clinical investigation until the telephone follow-up call. For four medicinal products, the total will be 44 subjects. In order to take account for a drop-out rate of 10%, 12 subjects will be included per medicinal product group and in total 48 subjects in the clinical investigation. 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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single application of phenethylamines (D1)

Evaluation 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 phenethylamines.

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.

Single application of benzodiazepines (D2)

Evaluation 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 benzodiazepines.

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.

Single application of cannabinoids (D3)

Evaluation 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 cannabinoids.

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.

Single application of opioids (D4)

Evaluation 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 opioids.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female healthy volunteers
* Age 18 to 70 years
* BMI between 18.5-30 kg/m2
* Weight between 50-100 kg
* Healthy as determined by the investigator or designee based on pre-study medical and surgical history and a health examination at enrollment
* 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
* No current drug usage defined as a negative urine drug test at enrollment and at visit 2
* Able to use Previct Drugs after initial training (defined as successfully performing a test after trying maximum three times per measurement)
* 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
* Abnormal ECG (QTc time \>450 ms) at enrollment
* Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse
* Current or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical 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
* Ongoing treatment with medications which may interfere with eye measurements based on clinical judgement
* Ongoing treatment with medications which may interfere with any of the medicinal products to be used
* History or presence of allergy or serious reaction to the medicinal products to be used
* History or presence of cardiovascular disease, e.g., arteriosclerosis, hypertension, or cor pulmonale
* History or presence of sleep-related breath disorder
* History or presence of gastrointestinal disease, e.g., paralytic ileus, acute abdomen, delayed gastric emptying, or chronic constipation
* History or presence of pulmonary disease, e.g., acute pulmonary insufficiency, severe respiratory depression with hypoxia, chronic obstructive lung disease, or bronchial asthma
* History or presence of autoimmune neuromuscular disease, e.g., myasthenia gravis
* Not able to read or understand the local language
* 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 enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes