Validation of the virtual reality PainCart using diazepam

Not Applicable

Completed

• Conditions: Pain; Not Applicable

• Registration Number: ISRCTN16108471
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-11-24
• Study Start: 2023-11-27
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1. Signed informed consent prior to any study-mandated procedure
2. Healthy male subjects, 18 to 35 years of age, inclusive at screening
3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg
4. Has the ability to communicate well with the Investigator in the Dutch language and is willing to comply with the study restrictions

Exclusion Criteria

1. History of symptoms or any significant including (but not limited to) neurological or psychiatric disorder, if assessed by the Principal Investigator as possibly interfering with the study objectives
2. High pain tolerance (80% or higher value for the pain tolerance of the electrical stair test)
3. Known presence of Virtual Reality Sickness (simulator sickness)
4. All tobacco-containing products must have been stopped 90 days prior to screening
5. Consume, on average, > 8 units/day of (methyl)-xanthines (e.g. coffee, tea, cola, chocolate) or not able to refrain from use during each stay at the CHDR clinic
6. Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC) and/or a positive alcohol breath test
7. Dark skin (Fitzpatrick skin type V - VI), wide-spread acne, tattoos or scarring on the lower limbs. Any deviations from this criterium will be judged and rationalised by the investigator.
8. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature)). Minor deviations from the normal range may be accepted if judged by the Investigator to have no clinical relevance.
9. Use of any medications (prescription or over-the-counter [OTC]), within 7days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the investigator documents the rationale
10. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the investigator clearly documents the rationale
11. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent. Exceptions will only be made if the investigator clearly documents the rationale
12. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified