Recruiting PHASE4 Neuropathic Pain

New treatment option for Neuropathic Pain

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

ClinicalTrials.gov ID: NCT06414356

What this study is testing

What is Ketamine?

Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuropathic pain.

Also referred to as Ketalar.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70. Healthy volunteers may be eligible.

You may be able to join if

  • 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...
  • Active Duty, Veterans, and retirees
  • Ketamine naïve for 1 year

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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...

The study team makes the final eligibility decision.

Where it's taking place

  • San Antonio, Texas, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.