Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06414356

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

Led by Margaux M. Salas, PhD · Updated on 2025-02-25

30

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Diagnosed with chronic neuropathic pain lasting 3 months or more
  • Biologic male or biologic female
  • Women of childbearing age must have no plans for pregnancy during the study, use contraception, and agree to pregnancy tests
  • Active duty military, veterans, retirees, or military dependents
  • No ketamine treatment in the past year
  • Moderate neuropathic pain scale rating between 4 and 7
Not Eligible

You will not qualify if you...

  • Cognitive dysfunction
  • Psychiatric illness involving psychosis
  • Neurocognitive disorder
  • History of traumatic brain injury
  • Acute cardiovascular disease or poorly controlled hypertension
  • Untreated or uncontrolled thyroid disease including hyperthyroidism
  • Severe liver or kidney disease or renal impairment
  • Recent heart attack, vascular disease, or other medical conditions contraindicating ketamine
  • Active substance abuse or risk of substance use
  • Pregnant, lactating, or planning pregnancy within 12 weeks after treatment
  • Elevated blood pressure or hypertension
  • Known allergy to ketamine
  • Hemodynamic instability or respiratory depression
  • Use of Theophylline, Aminophylline, sympathomimetics, vasopressin, or benzodiazepines
  • History of drug abuse or dependence
  • Inability to follow treatment protocols including food intake, medication restrictions, clinic observation, or post-treatment transportation arrangements

AI-Screening

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Trial Site Locations

Total: 1 location

1

Brooke Army Medical Center

San Antonio, Texas, United States, 78234

Actively Recruiting

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Research Team

M

Margaux M Salas, PhD

CONTACT

K

Kevin C Peterson, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

3

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