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RecruitingPhase 4

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

NCT06414356 · Margaux M. Salas, PhD

Recruiting
Status
Accepting participants
Phase 4
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Defense and Veterans Pain Rating Score (DVPRS)

    Measured over Up to 32 weeks

  • Brief Pain Inventory Scale (BPI)

    Measured over Up to 32 weeks

  • Life Satisfaction Questionnaire (LiSAT)

    Measured over Up to 32 weeks

  • Post-traumatic Stress Disorder Checklist (PCL-5)

    Measured over Up to 32 weeks

  • The Patient-Reported Outcomes Measurement Information System (PROMIS 29+2)

    Measured over Up to 32 weeks

  • Patient Health Questionnaire-9 (PHQ-9)

    Measured over Up to 32 weeks

  • Generalized Anxiety Disorder Scale

    Measured over Up to 32 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Brooke Army Medical CenterSan AntonioTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06414356 on ClinicalTrials.gov →

Last updated in the registry 2025-02-25. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits