• To assess the change in electrical pain perception induced by virtual reality.• To assess the effect of diazepam on electrical pain perception. • To assess the relationship between the electrical pain perception and personality characteristics.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is a comparison between diazepam and placebo
on the pain experience (difference between the VR wound and VR control
measurement) across all time points adjusting for pre-dose baseline
measurements.
Secondary outcome
N/A
Background summary
In a previous pilot study (CHDR2037), the pain and unpleasantness of a
nociceptive stimulus was successfully enhanced using Virtual Reality (VR).
During an electrical stimulation test, a wound simulation was presented at the
location of the electrodes via VR-glasses. When comparing this *enhanced pain*
test to a neutral VR pain test (i.e., without wound), healthy volunteers had 1)
decreased pain detection thresholds, 2) increased perception of pain intensity,
and 3) increased perception of pain unpleasantness. The success of the previous
iteration of the VR-PainCart has provided a new paradigm in which novel and
promising compounds that augment the affective component of pain can be tested.
Further validation of this testing method is therefore necessary to underline
its promise for future studies. To assess the sensitivity of the VR PainCart,
the affective component of pain will be reduced by administration of an oral
anxiolytic drug.
In a previous study, a single dose of diazepam was related to reduced cerebral
blood flow to the temporal regions and a reduced pain response to a cold
pressor test. Additionally, diazepam is known to influence emotional processing
and is commonly used to treat clinical anxiety even though the exact mechanism
is not yet identified. Diazepam has not yet been used in a study including VR
but is very well studied in other contexts and no negative effect is expected
on the experience of the simulation (e.g., dizziness, headache) other than a
decrease in anxiety.
In this study, we aim to include healthy male volunteers between the age of 18
and 35. To assess the sensitivity of the virtual reality pain test, a single
dose of diazepam (5mg) will be used to inhibit the affective pain component.
Study objective
• To assess the change in electrical pain perception induced by virtual reality.
• To assess the effect of diazepam on electrical pain perception.
• To assess the relationship between the electrical pain perception and
personality characteristics.
Study design
This is a randomized single centre, double-blind, placebo-controlled study to
investigate the effect of diazepam on the affective component of pain measured
with the Virtual Reality PainCart (VR). A maximum of 24 healthy subjects will
experience three PainCart setups: PainCart without VR (*normal*), VR-control
and VR-wound.
Intervention
Study drug or placebo will be administered to the subjects 5mg diazepam and
matching placebo formulations will be manufactured.
Study burden and risks
The risk of potential dependency is minimized by exclusion criteria on previous
dependency on drugs and/or medication or (history of) psychiatric illness. The
potential side effects are expected to be tolerable and manageable in clinical
setting.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
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 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 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84615.056.23 |