Recruiting

Ketamine

Sponsor:

Margaux M. Salas, PhD

Code:

NCT06414356

Conditions

Neuropathic Pain

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Ketamine

Magnesium sulfate

Ketamine + Magnesium sulfate

Study Details

Brief 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.

Conditions

Neuropathic Pain

PTSD

Study ID

NCT06414356

Start date

Oct 2, 2024

Status verified date

Feb, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Moderate Dose Ketamine

0.5 mg/kg/hr The total amount of ketamine for each participant is dependent on their body weight in kg per ideal body weight (IBW) formula.

This total ketamine dose will be injected into one 250 ml normal saline 0.9% solution with a rate of 62.5 ml/hr over four hours or until the contents of the bag are infused and flushed with 20 ml of normal saline

experimental: Moderate dose ketamine + magnesium sulfate

0.50 mg/kg/hr ketamine + 750 mg/hr Mg

active comparator: Magnesium sulfate

750 mg/hr

Interventions

Ketamine

Ketamine will be placed in 250 mL normal saline and infused at a rate of 62.5 mL/hr. Participants will receive intravenous infusions of ketamine for 4 hours each day in diminishing number of dosing events per week for the full 24-week infusion regime in an outpatient setting. (ketamine 0.5 mg/kg IBW/hr)

Magnesium sulfate

Magnesium sulfate 3 grams will be diluted into 250 mL normal saline and infused at a rate of 62.5 mL/hr (over 4 hours until the entire contents are infused and then flushed with 20 mL of normal saline). The Mg only group will be randomly assigned to one of the treatment groups (moderate dose ketamine, or moderate dose ketamine +Mg) after 2 weeks and complete the full 24-week infusion treatment regime of the randomly selected treatment group in an outpatient setting.

Ketamine + Magnesium sulfate

Participants will receive intravenous infusions of ketamine and magnesium sulfate in combination. Ketamine will be placed in 250 mL normal saline and infused at a rate of 62.5 mL/hr Participants will receive intravenous infusions of ketamine and magnesium sulfate for 4 hours each day in diminishing number of dosing events per week for the full 24-week infusion regime in an outpatient setting. (Ketamine 0.5 mg/kg IBW/hr + magnesium sulfate 3 grams diluted into 250 mL normal saline)

Primary outcome measure

  • Defense and Veterans Pain Rating Score (DVPRS) [ Time Frame: Up to 32 weeks ]
  • Brief Pain Inventory Scale (BPI) [ Time Frame: Up to 32 weeks ]
  • Life Satisfaction Questionnaire (LiSAT) [ Time Frame: Up to 32 weeks ]
  • Post-traumatic Stress Disorder Checklist (PCL-5) [ Time Frame: Up to 32 weeks ]
  • The Patient-Reported Outcomes Measurement Information System (PROMIS 29+2) [ Time Frame: Up to 32 weeks ]
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Up to 32 weeks ]
  • Generalized Anxiety Disorder Scale [ Time Frame: Up to 32 weeks ]

Central Contacts and Locations

Central contacts

Margaux M Salas, PhD

210-473-7447margaux.m.salas.ctr@health.mil

Kevin C Peterson, MD

210-916-7331kevin.c.peterson3.mil@health.mil

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Kevin Peterson, MD

210-916-2888kevin.c.peterson3.mil@health.mil

Jason Reed, DO

210-916-2888jason.l.reed28.mil@health.mil

More Information

Sponsor

Margaux M. Salas, PhD

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Keywords

  • Ketamine Hydrochloride

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Margaux M. Salas, PhD on 2025-02-25.