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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
United States
Texas
Brooke Army Medical Center
RECRUITING
San Antonio
Contact Information
Primary
Margaux M Salas, PhD
margaux.m.salas.ctr@health.mil
210-473-7447
Backup
Kevin C Peterson, MD
kevin.c.peterson3.mil@health.mil
210-916-7331
Time Frame
Start Date: 2024-10-02
Estimated Completion Date: 2027-05
Participants
Target number of participants: 30
Treatments
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
Sponsors
Leads: Margaux M. Salas, PhD

This content was sourced from clinicaltrials.gov