RecruitingPhase 4NCT06414356

The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD

The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD: A Prospective Randomized Design


Sponsor

Margaux M. Salas, PhD

Enrollment

30 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether outpatient ketamine infusions (a low-dose anesthetic given intravenously in a clinic) can reduce both chronic nerve pain (neuropathic pain) and PTSD symptoms in military veterans, active duty service members, and retirees. Ketamine has shown promise in treating both conditions in recent research. **You may be eligible if...** - You are between 18 and 70 years old - You have had chronic neuropathic pain for at least 3 months with moderate severity (pain score 4–7) - You are an active duty service member, veteran, or military retiree - You have not received ketamine in the past year - Women of childbearing age must not be planning pregnancy and must use contraception **You may NOT be eligible if...** - You have cognitive impairment, psychosis, or a neurocognitive disorder - You have had a traumatic brain injury (TBI) - You have uncontrolled high blood pressure or acute heart disease - You have untreated or uncontrolled thyroid disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

Ketamine will be placed in 250 mL normal saline and infused at a rate of 62.5 mL/hr. Participants will receive intravenous infusions of ketamine for 4 hours each day in diminishing number of dosing events per week for the full 24-week infusion regime in an outpatient setting. (ketamine 0.5 mg/kg IBW/hr)

DRUGMagnesium sulfate

Magnesium sulfate 3 grams will be diluted into 250 mL normal saline and infused at a rate of 62.5 mL/hr (over 4 hours until the entire contents are infused and then flushed with 20 mL of normal saline). The Mg 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 24-week infusion treatment regime of the randomly selected treatment group in an outpatient setting.

DRUGKetamine + Magnesium sulfate

Participants will receive intravenous infusions of ketamine and magnesium sulfate in combination. Ketamine will be placed in 250 mL normal saline and infused at a rate of 62.5 mL/hr Participants will receive intravenous infusions of ketamine and magnesium sulfate for 4 hours each day in diminishing number of dosing events per week for the full 24-week infusion regime in an outpatient setting. (Ketamine 0.5 mg/kg IBW/hr + magnesium sulfate 3 grams diluted into 250 mL normal saline)


Locations(1)

Brooke Army Medical Center

San Antonio, Texas, United States

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NCT06414356


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