A study to evaluate whether increased codeine levels are seen when both codeine and ketamine are given in small doses to well volunteers.
- Conditions
- The possibility that ketamine,an anaesthetic medication but which is also used at much lower doses, to help try and control severe chronic nerve pain, may increase the effective blood levels of opioids such as codeine or morphine that are often given in conjunction with ketamine.This study is looking at drug metabolism not pain management or anaesthesiologyOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12610000283077
- Lead Sponsor
- Flinders University- Department of Clinical Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 10
Participant is capable of completing all participant assessments and complying with the study procedures, is able to give fully informed written consent, Normal performance status = Australian-modified Karnofsky performance stauts of 100.
Any history of drug or alcohol abuse, any known allergy to either of the study medications,alcohol consumption during the trial period, on any regular or as needed medications including opioids and Non Steroidal Anti Inflammatory Drugs(NSAIDs),anaemia, renal dysfunction with creatinine clearance calculated as less than 25 ml/minute. Hepatic impairment defined as 2 times upper limit of mormal for 2 or more hepatic enzymes, International normalized ratio (INR >1.2 )– not treated with warfarin, documented respiratory failure induced by any opiate medication,recent seizures or history of uncontrolled epilepsy, medically assessed history of uncontrolled hypertension, cardiac arrhythmias, cardiac failure, ischaemic heart disease or history of cerebral vascular accident, cerebral trauma, intracerebral mass or previous intracerebral haemorrhage, currently taking monoamine oxidase inhibitors (MAOIs) or who have been taking non-reversible monoamine oxidase inhibitors within 4 weeks prior to study entry or reversible MAOIs within 5 days of study entry, history of increased intraocular pressure (e.g. glaucoma), schizophrenia, acute psychosis, acute intermittent porphyria, uncontrolled hyperthyroidism,women pregnant or lactating and if at risk of pregnancy must have appropriate and effective contraception in place.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To define any clinically relevant drug to drug interaction between codeine and ketamine in healthy volunteers. This will be measured by taking in total 22 blood sample.[At 08.00. 08.30, 09.00, 09.30, 10.00, 11.00, 12.00, 13.00,14.00,15.00 and 16.00 on days 3 and 4 of the study.];This study will allow the relationship between opioid metabolism in the <br> presence of ketamine to be delineated in a way that can inform <br> clinical practice if the phase III study is positive.[The samples of blood and urine collected will be analysed in the laboratory over the next few months and results should be available within 12 months]
- Secondary Outcome Measures
Name Time Method Given that morphine and codeine are metabolised through the same pathways, this study will also inform practice with morphine.[The samples of blood and urine collected will be analysed in the laboratory over the next few months and results should be available within 12 months];Given the almost universal prescribing of ketamine in the presence of an opioid, this study will have wide implications for practice internationally in acute pain including post-operative analgesia, chronic pain and palliative care[The samples of blood and urine collected will be analysed in the laboratory over the next few months and results should be available within 12 months]