Validation of the Virtual Reality PainCart using diazepam: a randomized single center, double-blind, placebo-controlled, cross-over study investigating the affective component of pai
- Conditions
- painaffective modulation of painPain experience
- Registration Number
- NL-OMON56408
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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 willing to comply with the study restrictions.
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 rationale is
documented by the investigator. 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 rationale
is clearly documented by the investigator. 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 rationale is clearly documented by the investigator. 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
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is a comparison between diazepam and placebo<br /><br>on the pain experience (difference between the VR wound and VR control<br /><br>measurement) across all time points adjusting for pre-dose baseline<br /><br>measurements. </p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>