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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Margaux M. Salas, PhD
Study ID
NCT06414356
Phase
PHASE4
Status
Recruiting
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Conditions

  • Neuropathic Pain
  • PTSD

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Ketamine — DRUG
    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 — DRUG
    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 — DRUG
    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)

Study Details

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.

Key Dates

Start date
Oct 2, 2024
Status verified
Feb 2025
Primary completion
Apr 30, 2025
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Defense and Veterans Pain Rating Score (DVPRS) [ Time Frame: Up to 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brooke Army Medical CenterSan AntonioTexas78234
Kevin Peterson, MD
[email protected]
210-916-2888
Jason Reed, DO
[email protected]
210-916-2888

Find similar trials in San Antonio, TX

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Brooke Army Medical Center· San Antonio, TX

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