Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT06414356
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06414356
Study Brief:
Protocol Section:
NCT06414356