Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-29
Brief Title:
The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD
Sponsor:
Margaux M Salas PhD
Organization:
Brooke Army Medical Center
Study Overview
Official Title:
The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD A Prospective Randomized Design
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is aimed to evaluate outpatient ketamine infusion within a military chronic neuropathic pain population and its effect on PTSD Currently this is a pilot study with 30 participants Participants will be randomized to 1 a moderate dose ketamine 2 moderate dose ketamine Mg or 3 a magnesium control group Participants will complete self-reported pain and PTSD questionnaires throughout the 24-week study period The outlined strategy will provide evidence for the utility of ketamine in neuropathic pain management and pain associated comorbidities within a military population
Detailed Description:
Subjects will be recruited with no target toward ethnicity gender or race Active duty veteran retiree and military dependents between the ages of 18-70 years old with an established diagnosis of chronic neuropathic pain will be identified and screened for study inclusion Enrollees will have had neuropathic pain 3 months duration report a pain score between 4-7 and meet inclusionexclusion criteria for the study Since ketamines influence on PTSD is a secondary measure any patients with a PCL-5 score 33 will be noted After informed consent is obtained participants will be randomized into a 1 moderate dose ketamine 2 moderate dose ketamine Mg or 3 a magnesium control group The magnesium-only group will be randomly assigned to one of the treatment groups moderate dose ketamine or moderate dose ketamine Mg after 2 weeks and complete the full infusion treatment regime of the randomly selected treatment group Administration of ketamine will occur in diminishing number of dosing events Week 1 2 will consist of 3 treatments per week Weeks 3 4 will consist of 2 treatments per week Weeks 5 6 will consist of 1 treatment per week Booster treatments will be administered week 10 and week 24 Booster treatments will only be 1 infusion that week Participants will fill out questionnaires before and after each infusion- day concerning their pain PTSD anxiety depression and quality of life Participants will be evaluated at least 5 days prior to the first treatment and 30-35 days after the final infusion Participants will continue their current pain management regimen during the study and be instructed to use analgesics only as needed Pain medication use will be recorded throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None