The objectives of the study are to assess whether:(1) SNP will reduce the occurrence of psychomimetic side effects during exposure to low-dose ketamine;(2) SNP will reduce the ketamine-induced increase in blood pressure and cardiac output;(3) SNP is…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische (neuropathische) pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psychedelic and negative effects are measured using visual analog scales
ranging from 0 (no effect) to 10 cm (maximum effect) of the Bowdle and Bond &
Lader questionnaires (Appendix 1A and B).11,12
Secondary outcome
Pain relief from ketamine (S vs RS) and placebo vs SNP.
Background summary
Since its introduction in the early 1960s in clinical practice, ketamine has
progressed from a general anesthetic to a more versatile drug and is currently
frequently used in the treatment of acute and chronic pain, therapy-resistant
major depression, migraine and post-traumatic stress disorder. Ketamine is a
drug that interacts with many receptors but antagonism of the
N-methyl-D-aspartate receptor (NMDAR), an excitatory glutamate receptor
ubiquitously present in the central nervous system, is considered most
important. An important negative ketamine effect, that causes many physicians
to be cautious with its use, is the induction of dissociative, psychomimetic
and other central nervous system (CNS)-related side effects. We hypothesize
that negative effects during ketamine treatment is related to the reduced NO
formation from NMDAR antagonism. In this study we will assess the effect of
sodium nitroprusside (SNP), and NO donor, on ketamine*s positive and negative
effects in a group of healthy volunteers. The effect of SNP will be tested in
subjects that received the S-enantiomer S-ketamine or racemic (R,S) ketamine.
Study objective
The objectives of the study are to assess whether:
(1) SNP will reduce the occurrence of psychomimetic side effects during
exposure to low-dose ketamine;
(2) SNP will reduce the ketamine-induced increase in blood pressure and cardiac
output;
(3) SNP is without effect on ketamine-induced pain relief;
(4) SNP is effective in reducing negative effects in both S-ketamine and
RS-ketamine treated subjects.
Study design
Double blind, randomized and placebo controlled
Study burden and risks
The expected side effects are topic of the study. We expect mild effects with
most prevalent symptoms *drug high* and dizziness. Other side effects that may
occur are nausea (which we will treat with ondansetron 4 mg iv), hypertension
(we expect just mild effects with an increase in CO from 6 to about 9 L/min;
this is an acceptable and mild increase), mild tachycardia. During concomitant
infusion of SNP the hemodynamics effects will possibly be less. Finally some
bruising and hematomas formation may occur at sites at which the iv and
arterial entered the skin. The pain tests cause no side effects.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Male subjects, aged 18-34 years with a body mass index < 30 kg/m2.
Exclusion criteria
Severe medical disease including hypertension, liver/renal disease, neurological disorders, diaphragmatic hernia/pyrosis; (history of) psychiatric or neurological disease; allergy to study medication; (history of) illicit drug abuse/alcoholism.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-000550-37-NL |
| CCMO | NL52444.058.15 |