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Plasma Concentration of Ketamine and Norketamine .

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ClinicalTrials.gov Identifier: NCT02016664
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Qutaiba Tawfic, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE December 20, 2013
Last Update Posted Date March 1, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Plasma level of oral ketamine and norketamine at two different doses. [ Time Frame: 0,30,60,90 and 120 min after ingestion. ]
Plasma level of ketamine and norketamine will be tested just before ingestion of oral ketamine (trough level) and then after at 30,60,90 and 120min. Patients will be already using oral ketamine therapy for 7 days before the test. This test will be repeated twice on 2 different doses (10 and 2o mg q 8 hr).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Mean Pain Score [ Time Frame: week 1 and week 2 ]
Mean pain score will be recorded at the end of one week of ingestion for each dose.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plasma Concentration of Ketamine and Norketamine .
Official Title  ICMJE Plasma Concentration of Ketamine and Norketamine in Patients on Oral Ketamine for Chronic Neuropathic Pain : A Pilot Study.
Brief Summary Oral ketamine is increasingly used by doctors to both reduce the amount of narcotic pain medication consumed and to improve chronic pain management in difficult cases. How much is absorbed when taken orally, as opposed to intravenously ,is unknown. Ketamine may cause sedation, and occasionally cognitive impairment. Therefore, there are safety concerns associated with its usage as an out-patient may engage in activities where cognitive impairment is dangerous,such as driving. This study is designed to measure the plasma concentrations of ketamine and its active metabolite, norketamine, in people taking low dose oral ketamine for chronic pain. The goal of the study is to verify that low dose oral ketamine produces plasma concentrations below the level associated with toxic symptoms,and thus can be safely used long-term for the treatment of chronic pain .
Detailed Description

This is a non-randomized, cohort study to measure the serum uptake of low dose oral ketamine in chronic pain patients. The SJHC pharmacy has a list of patients to whom they dispense oral ketamine. We plan to recruit fifteen patients from this patient group.

This is a pilot study and very little information is available to help with sample size calculations. We also plan to measure change in mean pain score from Day to Day 14 using the Brief Pain Inventory (BPI) This data will aid the design and calculation of sample size in future studies. Study Design: Days 1-7: Following informed consent, the patient's demographic information and initial assessment will be completed on Day 1 at the first visit. They will be allowed to continue all usual systemic analgesic medications. They will be given instructions on how to take the study medication and will be given a list of foods that could possibly induce or inhibit the enzyme, Cyp3A4 or Cyp2B6 (i.e. grapefruit or grapefruit juice). Subjects will be given a 7 day supply of 10 mg ketamine tablets. The patients will be instructed to take one ketamine tablet three times per day at specified times for seven days and to return to clinic on Day 7. They will be instructed not to take their morning dose of ketamine and to eat a light breakfast on Day 7. Upon arrival, the patients will complete the Brief Pain Inventory and side effects questionnaire. The patient will have a 20 gauge (saline locked) IV started in the antecubital fossa to allow for five blood samples: Time Zero, 30, 60, 90 and 120 minutes. The first blood sample at Time 0 will be obtained just before the patient takes his/her oral dose of ketamine (trough concentration). The four remaining samples will be taken after the patient ingests his/her 10 mg ketamine dose. Time Activity Arrival Complete BPI, side effect questionnaire Time Zero Blood draw, then take 10mg oral ketamine dose 30 minutes post ingestion Blood draw 60 minutes post ingestion Blood draw 90 minutes post ingestion Blood draw 120 minutes post-ingestion Blood Draw Days 8-14: The subjects will be given a supply of 20 mg ketamine capsules and instructed to take them three times per day, at specified times, and to return to clinic on Day 14. The instructions and procedures at the second clinic visit will be the same as on Day 7.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Chronic Pain
Intervention  ICMJE Drug: Ketamine
The St.Joseph's Heath Care Pharmacy will supply the compounded oral ketamine capsules. Patients who are going to participate in this study are already taking this oral ketamine as a part of their chronic pain medications. No new patient will start oral ketamine for the sake of this study. Two doses of oral ketamine will be used for the same patient, 10 mg and 20 mg every 8 hours. These doses are the standard doses in our clinic. Other clinics using much higher doses.
Study Arms  ICMJE Experimental: Chronic pain patients on oral ketamine

Days 1-7:

Subjects will be given a 7 day supply of 10 mg ketamine tablets three times per day for seven days and to return to clinic on Day 7. They will be instructed not to take their morning dose of ketamine and to eat a light breakfast on Day 7. Upon arrival, the patient will have a 20 gauge (saline locked) IV started in the antecubital fossa to allow for five blood samples: Time Zero,30, 60,90 and 120 minutes. The first blood sample at Time 0 will be obtained just before the patient takes his/her oral dose of ketamine.

Days 8-14:

The subjects will be given a supply of 20 mg ketamine capsules and instructed to take them three times per day, at specified times, and to return to clinic on Day 14. The instructions and procedures at the second clinic visit will be the same as on Day 7.

Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
15
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient currently takes oral ketamine for the treatment of chronic neuropathic pain.
  • Age >18 and < 75 years
  • Both males and females 4.Ability to speak English adequately to understand the consent and participate in the study
  • No other route of ketamine within past 7 days (Topical/IV)

Exclusion Criteria:

  • Patient receiving liver enzyme inducers or inhibitors of Cytochrome CYP3A4, or CYP2B6 like clarithromycin, rifampin, and recent ingestion of grapefruit juice.
  • Patients who have had gastric bypass surgery
  • Patients who did not follow the prescribed protocol
  • Renal Failure defined as Creatinine Clearance <50 mL/min
  • Hepatic insufficiency by history
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02016664
Other Study ID Numbers  ICMJE OKPCS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qutaiba Tawfic, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patricia Morley-Foster, MD, FRCPC Department of Anesthesia and Perioperative Medicine, Western University, Canada.
PRS Account Lawson Health Research Institute
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP