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Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04220489
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
Jacques E. Chelly, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE November 21, 2019
First Posted Date  ICMJE January 7, 2020
Last Update Posted Date December 20, 2021
Actual Study Start Date  ICMJE December 17, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2021)
  • Post-surgical Patient Care Assistance (PCA) opioid utilization [ Time Frame: 72 hours post-dose ]
    Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Hydromorphone Patient Care Assistant (PCA) usage during the first 72 hours postoperatively will be recorded. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.
  • Post-surgical pain rating using the Visual Analog Scale (VAS) [ Time Frame: 72 hours post-dose ]
    Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome. Pain will be monitored every four hours from the time the participant enters the PACU until discharge from the hospital, except during the night when the participant is asleep.
  • Post-surgical opioid utilization using electronic medication review [ Time Frame: 72 hours post-dose ]
    Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.
  • Post-surgical opioid utilization using electronic medication review [ Time Frame: 6-week follow-up visit ]
    Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.
  • Pre-surgical opioid utilization using the Pain Medication Review Form [ Time Frame: Screening visit ]
    Pre-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking.
  • Post-surgical opioid utilization using the Pain Medication Review Form [ Time Frame: Day 10-14 Post-Operative Visit ]
    Post-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking. The more opioid medications taken, the worse the outcomes.
  • Post-surgical opioid utilization using the Pain Medication Review Form [ Time Frame: 6-week follow-up visit ]
    Post-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking. The more opioid medications taken, the worse the outcomes.
  • Pre-surgical pain rating using the Visual Analog Scale (VAS) [ Time Frame: Screening visit ]
    Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores present a worse outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2020)
  • Post-surgical Patient Care Assistance (PCA) opioid utilization [ Time Frame: 72 hours post-dose ]
    Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Hydromorphone Patient Care Assistant (PCA) usage during the first 72 hours postoperatively will be recorded. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.
  • Post-surgical pain rating using the Visual Analog Scale (VAS) [ Time Frame: 72 hours post-dose ]
    Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome. Pain will be monitored every four hours from the time the participant enters the PACU until discharge from the hospital, except during the night when the participant is asleep.
  • Post-surgical opioid utilization using electronic medication review [ Time Frame: 72 hours post-dose ]
    Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.
  • Post-surgical opioid utilization using electronic medication review [ Time Frame: 6-week follow-up visit ]
    Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.
  • Pre-surgical opioid utilization using the Pain Medication Review Form [ Time Frame: Screening visit ]
    Pre-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking.
  • Post-surgical opioid utilization using the Pain Medication Review Form [ Time Frame: Day 10-14 Post-Operative Visit ]
    Post-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking. The more opioid medications taken, the worse the outcomes.
  • Post-surgical opioid utilization using the Pain Medication Review Form [ Time Frame: 6-week follow-up visit ]
    Post-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking. The more opioid medications taken, the worse the outcomes.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2020)
  • Pre-surgical emotional distress related to depression [ Time Frame: Screening visit ]
    Pre-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome.
  • Post-surgical emotional distress related to depression [ Time Frame: Day 10-14 Post-Operative Visit ]
    Post-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome.
  • Post-surgical emotional distress related to depression [ Time Frame: 6-week follow-up visit ]
    Post-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome.
  • Pre-surgical emotional distress related to anxiety [ Time Frame: Screening visit ]
    Pre-surgical emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Anxiety Short Form questionnaire. There are 7 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 7 being the least severe score and 35 being the most severe score. Higher scores present a worse outcome.
  • Post-surgical emotional distress related to anxiety [ Time Frame: Day 10-14 Post-Operative Visit ]
    Post-surgical emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Anxiety Short Form questionnaire. There are 7 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 7 being the least severe score and 35 being the most severe score. Higher scores present a worse outcome.
  • Post-surgical emotional distress related to anxiety [ Time Frame: 6-week follow-up visit ]
    Post-surgical emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Anxiety Short Form questionnaire. There are 7 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 7 being the least severe score and 35 being the most severe score. Higher scores present a worse outcome.
  • Pre-surgical satisfaction with social roles and activities [ Time Frame: Screening visit ]
    Pre-surgical satisfaction with social roles and activities will be measured by assessment of participant's answers to the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least satisfaction score and 40 being the most satisfaction score. Higher scores present a better outcome.
  • Post-surgical satisfaction with social roles and activities [ Time Frame: Day 10-14 Post-Operative Visit ]
    Post-surgical satisfaction with social roles and activities will be measured by assessment of participant's answers to the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least satisfaction score and 40 being the most satisfaction score. Higher scores present a better outcome.
  • Post-surgical satisfaction with social roles and activities [ Time Frame: 6-week follow-up visit ]
    Post-surgical satisfaction with social roles and activities will be measured by assessment of participant's answers to the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least satisfaction score and 40 being the most satisfaction score. Higher scores present a better outcome.
  • Pre-surgical pain rating using the Magill Pain Questionnaire-Short Form [ Time Frame: Screening visit ]
    Pre-surgical pain ratings will be measured by the assessment of participant's answers to the Magill Pain Questionnaire-Short Form questionnaire. There are 14 categories of pain that participants will record experiencing on a scale of 0 being no pain and 3 being severe pain. The lowest possible score is 0 and the highest possible score is 45. This questionnaire has a present pain intensity (PPI) scale of 0 being no pain to 5 being excruciating pain. Higher scores present a worse outcome.
  • Post-surgical pain rating using the Magill Pain Questionnaire-Short Form [ Time Frame: 6-week follow-up visit ]
    Post-surgical pain ratings will be measured by the assessment of participant's answers to the Magill Pain Questionnaire-Short Form questionnaire. There are 14 categories of pain that participants will record experiencing on a scale of 0 being no pain and 3 being severe pain. The lowest possible score is 0 and the highest possible score is 45. This questionnaire has a present pain intensity (PPI) scale of 0 being no pain to 5 being excruciating pain. Higher scores present a worse outcome.
  • Pre-surgical pain rating using the Pain Catastrophizing Scale [ Time Frame: Screening visit ]
    Pre-surgical pain ratings will be measured by the assessment of participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome.
  • Post-surgical pain rating using the Pain Catastrophizing Scale [ Time Frame: Day 10-14 Post-Operative Visit ]
    Post-surgical pain ratings will be measured by the assessment of participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
  • Post-surgical pain rating using the Pain Catastrophizing Scale [ Time Frame: 6-week follow-up visit ]
    Post-surgical pain ratings will be measured by the assessment of participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
  • Pre-surgical opioid analgesic efficacy using the Cold-Pressor Pain Sensitivity Test [ Time Frame: Screening visit ]
    Pre-surgical opioid analgesic efficacy will be measured by the results of the Cold-Pressor Pain Sensitivity Test, where the participant will submerge their hand in ice water for up to four minutes at thirty minutes before and thirty minutes after the participant's opioid pain medication is taken. Pain tolerance is defined as the time in seconds that it takes for the participant to withdraw their hand from the ice water. Pain threshold, tolerance and cut-off will be recorded using a stop watch. The McGill Pain Questionnaire short form will be completed after each test. Opioid-analgesic efficacy will be estimated by the change in pain threshold and tolerance observed after the opioid was consumed relative to initial assessment of pain threshold and tolerance. The higher the threshold and tolerance after opioid consumption, the better the outcomes.
  • Post-surgical opioid analgesic efficacy using the Cold-Pressor Pain Sensitivity Test [ Time Frame: 6-week follow-up visit ]
    Post-surgical opioid analgesic efficacy will be measured by the results of the Cold-Pressor Pain Sensitivity Test, where the participant will submerge their hand in ice water for up to four minutes at thirty minutes before and thirty minutes after the participant's opioid pain medication is taken. Pain tolerance is defined as the time in seconds that it takes for the participant to withdraw their hand from the ice water. Pain threshold, tolerance and cut-off will be recorded using a stop watch. The McGill Pain Questionnaire short form will be completed after each test. Opioid-analgesic efficacy will be estimated by the change in pain threshold and tolerance observed after the opioid was consumed relative to initial assessment of pain threshold and tolerance. The higher the threshold and tolerance after opioid consumption, the better the outcomes.
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 Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
Official Title  ICMJE Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery: A Randomized, Double-blind, Placebo-controlled Trial
Brief Summary

The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomy/fusion when compared to placebo

Opioid dependence will be defined as daily opioid use (2 or more doses per day) for a period of two-months or longer. Intraoperatively, patients will receive a 1 mg/kg dose of intravenous ketamine or saline with 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr or saline will be run to conclude at 24 hours after the end of the surgery (fascial closure). The primary outcome measure will be hydromorphone PCA usage during the first 72 hours postoperatively. Secondary outcome measures will be VAS pain scores at rest and with movement in PACU, 24 hr, 48 hr, 72 hr, 2 week (post-op visit), 6 week follow-up visit, as well as, McGill Pain Questionnaire, Pain Catastrophizing Scale, and emotional distress surveys assessing depression and anxiety at preop/screening, postop and 6 week follow-up (PROMIS Emotional Distress-Anxiety Short Form, PROMIS Emotional Distress-Depression Short Form), as well as a Neuro-QOL Short Form v1.1 - Satisfaction with Social Roles and Activities .

Detailed Description

Patients will be recruited from the University of Pittsburgh Medical Center (UPMC) Neurosurgery Clinic and Operating Room Schedule. The primary surgeon will identify patients who would be eligible for inclusion, ask them if they would be interested in participating, and if so, the enrollment and consent process would be initiated. The participating neurosurgeons include Dr. Okonkwo and Dr. Hamilton, who have agreed to allow us access to their patients. Informed consent will be performed by the surgeon or the PI. Enrollment will be performed by the study coordinator and/or trained representative from the Acute Interventional Perioperative Pain Service (AIPPS). Enrollment will include review of eligibility, and detailed explanation of the study.

Screening Visit:

After patients are enrolled into the study at the preoperative neurosurgery clinic, a number of forms will be filled out by the participants: McGill Pain questionaire-Short form, pain medication review form, and the Pain Catastrophizing Scale (PCS) (Sullivan, 1995). PROMIS Emotional Distress-Anxiety Short Form and PROMIS Emotional Distress-Depression Short Form, Brief Psychiatric Rating Scale and Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities will also be completed.

Pre-Operative Visit:

The participant will be asked to come into the Aiken Medical Building, Suite 407 on a date after the clinic visit but before their day of surgery for a Pre-Operative Visit. Investigators will work with the participant to determine their opioid dose regimen, and the participant will be asked to come into the Aiken Medical Building thirty minutes before their opioid dose is due and will be asked to bring with them their upcoming dose of pain medication. Prior to taking their pain medication, the participant will then be administered a cold-pressor pain sensitivity test. Heart rate and blood pressure will be recorded before and after the cold-pressor test. Once the cold pressor test is completed, the McGill Pain Questionnaire will be administered. After this questionnaire is complete, the participant will take the dose of opioid medication they have brought from home and are scheduled to receive and will wait in the clinic for 30 minutes for the pain medication to take effect. Once the 30 minutes is complete, the cold-pressor test will be repeated, heart rate and blood pressure collected before and after, and McGill Pain Questionnaire will be administered again.

Surgical Visit:

At the day of surgery, participants will be seen by team members of the Acute Interventional Perioperative Pain Service preoperatively. Patients will be randomized into the Ketamine Group or the Placebo Group.

A standardized general anesthesia protocol will be used by the hands-on provider. All drugs used intraoperatively, including total hydromorphone dose, will be collected from the electronic chart.

The amount of narcotics and non-narcotic analgesics administered in the operative and postoperative period will be collected from the electronic chart from day of surgery until discharge. Visual Analogue Scale (VAS) pain scores will be collected.

Post-Op Visit:

Patients will follow-up at Neurosurgery clinic at 10-14 days postoperatively. At this time daily opioid usage will be assessed and converted to morphine equivalents/24 hr. At this visit: pain medication review form, and the Pain Catastrophizing Scale (PCS) (Sullivan, 1995). PROMIS Emotional Distress-Anxiety Short Form and PROMIS Emotional Distress-Depression Short Form, Brief Psychiatric Rating Scale and Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities will also be completed by the participant.

6-Week Follow-Up Visit:

The participant will be asked to come to the Aiken Medical Building, Suite 407 approximately 6 weeks after their surgery. Investigators will work with the participant to determine their post-operative opioid dose regimen. Prior to taking their pain medication, the participant will then be administered a cold-pressor pain sensitivity test, in a manner identical to that use during the pre-operative assessment.In addition to the McGill Pain Questionnaire-Short form, a pain medication review form, the Pain Catastrophizing Scale (PCS) (Sullivan, 1995), the PROMIS Emotional Distress-Anxiety Short Form, the PROMIS Emotional Distress-Depression Short Form, Brief Psychiatric Rating Scale and Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities will also be completed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, Randomized, Double-Blind, Placebo Controlled trial involving opiate-dependent patients undergoing lumbar spine surgery
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid Dependence
  • Chronic Pain
Intervention  ICMJE
  • Drug: Ketamine
    Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.
    Other Name: Ketalar
  • Drug: Placebo Comparator
    Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
    Other Name: Placebo Group
Study Arms  ICMJE
  • Experimental: Ketamine Group
    Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo Group
    Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).
    Intervention: Drug: Placebo Comparator
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Patients undergoing lumbar, thoracic or cervical spine surgery of at least one level, and no more than 6 levels.
  • Patients with chronic back pain (>3 months)
  • Anaesthetic risk assessment (ASA) 1-3
  • Opiate-dependent with daily opiate use for at least 2 months and regimented daily narcotic dose twice a day/bis in die (BID) or greater or use of a regimented opioid pump

Exclusion Criteria

  • Intolerance or known allergy to ketamine
  • History of increased intraocular pressure (> 22mmHg)
  • Uncontrolled hypertension (systolic blood pressure greater than or equal to 180, diastolic blood pressure greater than equal to 100)
  • Increased intracranial pressure
  • History of psychosis
  • Pregnancy
  • Patients with significant liver disease {signs and symptoms of liver injury, such as discolored skin and eyes that appear yellowish, abdominal pain and swelling, Itchy skin that doesn't seem to go away, dark urine color, pale stool color, bloody or tar-colored stool, chronic fatigue, nausea, loss of appetite, with or without elevated Liver Function Tests (LFTs): aspartate aminotransferase (AST) > 120 IU/ml, alkaline phosphatase (AP) >130 IU/ml, and alanine aminotransferase (ALT) >40 IU/ml}
  • Patients with exposure to Cytochrome P450, family 3, subfamily A (CYP3A) and / or Cytochrome P450 Family 2 Subfamily B Member 6 (CYP2B6) inhibitors, including the herbs and the over-the-counter compounds (list of drugs can be found at http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy Monroe 412-609-6161 Monroeal@upmc.edu
Contact: Brittany Norton 412-623-4135 nortonbe@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04220489
Other Study ID Numbers  ICMJE STUDY19020144
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data. In the future, the investigators may decide to share data with other investigators both within and outside of this institution. If that were to occur, we would de-identify all of the information prior to sharing any data in this way.
Current Responsible Party Jacques E. Chelly, University of Pittsburgh
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jacques E. Chelly
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacques E Chelly, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2021

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