A first-in-human explorative pilot study in healthy volunteers measuring eye parameters with a new mobile phone application for future monitoring of patients in treatment of substance use disorder.
- Conditions
- substance use disorder (SUD)addiction
- Registration Number
- NL-OMON53553
- Lead Sponsor
- Kontigo Care AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
1. Male or female healthy volunteers
2. Age 18 to 70 years
3. BMI between 18.5-30 kg/m2
4. Weight between 50-100 kg
5. Healthy as determined by the investigator or designee based on pre-study
medical and surgical history and a health examination at enrollment
6. 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
7. No current drug usage defined as a negative urine drug test at enrollment
and at visit 2
8. Able to use Previct Drugs after initial training (defined as successfully
performing a test after trying maximum three times per measurement)
9. Been informed of the nature, the scope, and the relevance of the clinical
investigation
10. Voluntarily agreed on participation and has duly signed the Informed
Consent Form
1. Participating in another clinical investigation which may affect the study
outcome according to clinical judgement
2. Pregnancy or Lactating
3. Blind
4. Deaf
5. Abnormal ECG (QTc time>450 ms) at enrollment
6. Current or recent history of alcohol misuse assessed by AUDIT where >=6
points for women or >=8 points for men indicates a potential misuse
7. Current or history of psychiatric disorder or drug misuse assessed by
M.I.N.I where the outcome will be based on clinical judgement
8. Any disease or condition that may influence pupillary reflexes based on
clinical judgement
9. Undergone eye surgery that may influence pupillary reflexes based on
clinical judgement
10. Ongoing treatment with medications which may interfere with eye
measurements based on clinical judgement
11. Ongoing treatment with medications which may interfere with any of the
medicinal products to be used
12. History or presence of allergy or serious reaction to the medicinal
products to be used
13. History or presence of cardiovascular disease, e.g., arteriosclerosis,
hypertension, or cor pulmonale
14. History or presence of sleep-related breath disorder
15. History or presence of gastrointestinal disease, e.g., paralytic ileus,
acute abdomen, delayed gastric emptying, or chronic constipation
16. History or presence of pulmonary disease, e.g., acute pulmonary
insufficiency, severe respiratory depression with hypoxia, chronic obstructive
lung disease, or bronchial asthma
17. History or presence of autoimmune neuromuscular disease, e.g., myasthenia
gravis
18. Not able to read or understand the local language
19. Any other condition that as judged by the investigator may make the
follow-up or investigation inappropriate
20. That according to the Declaration of Helsinki is deemed unsuitable for
study enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>- For each medicinal product (D1-D4), the fraction of collected pupillometry<br /><br>data from the mobile phone application at baseline and under the influence of<br /><br>D1-D4, which can be transformed into pre-defined key features using native<br /><br>pupillogram.</p><br>
- Secondary Outcome Measures
Name Time Method