RECRUITING

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

Conditions

Neuropathic Pain PTSD Ketamine Hydrochloride

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD: A Prospective Randomized Design

Quick Facts

Study Start:2024-10-02

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06414356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Margaux M Salas, PhD

CONTACT

210-473-7447

margaux.m.salas.ctr@health.mil

Kevin C Peterson, MD

CONTACT

210-916-7331

kevin.c.peterson3.mil@health.mil

Study Locations (Sites)

Brooke Army Medical Center

San Antonio, Texas, 78234

United States

Collaborators and Investigators

Sponsor: Margaux M. Salas, PhD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-10-02

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

Ketamine Hydrochloride

Additional Relevant MeSH Terms

Neuropathic Pain
PTSD