Outpatient ketamine infusion for chronic pain and PTSD in military personnel

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the effects of outpatient ketamine infusion on chronic neuropathic pain and PTSD among military personnel. It involves 30 participants who will be randomized into three groups: one receiving moderate dose ketamine, another receiving moderate dose ketamine with magnesium, and a control group receiving magnesium only. Participants will complete self-reported questionnaires on pain and PTSD throughout the approximately 24-week study period. The study aims to provide evidence for the effectiveness of ketamine in managing neuropathic pain and associated comorbidities in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-70 years old with Chronic Neuropathic Pain \>= 3 months
* Biologic male or biologic female
* Women of childbearing age will be included if there are no plans of pregnancy within the study period, the participant agrees to actively utilize contraception throughout the study, and agrees to pregnancy tests
* Active Duty, Veterans, and retirees
* Ketamine naïve for 1 year
* Moderate Neuropathic pain Scale 4-7

Exclusion Criteria:

* Cognitive dysfunction
* Psychiatric illness involving psychosis
* Neurocognitive disorder
* Patients with Traumatic Brain Injury (TBI)
* Acute cardiovascular disease or poorly controlled hypertension
* Untreated or uncontrolled thyroid disease
* Hyperthyroidism
* Severe liver or renal disease
* Renal impairment
* History of recent heart attack, vascular disease, or any other medical condition that may be deemed by a provider as a contraindication to receiving ketamine
* Active substance abuse
* Pregnant or lactating
* Patients who are planning to become pregnant within 12 weeks of treatment completion
* Elevated Blood Pressure/hypertension
* Known hypersensitivity to Ketamine
* Hemodynamic instability
* Respiratory depression
* Use of Theophylline or Aminophylline, Sympathomimetics and Vasopressin,
* Use of Benzodiazepines
* A history of drug abuse or dependence
* Active risk of substance use
* Patients who are not able to abide by the pre-treatment and posttreatment clinical protocol, such as food intake, abstaining from certain medications, unable to remain in the clinic for a minimum of 1 hour for observation, and cannot provide the name and phone number of the party who will pick them up post-treatment

Where it's running

• Brooke Army Medical Center
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Margaux M Salas, PhD
• Email: margaux.m.salas.ctr@health.mil
• Phone: 210-473-7447

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.