Outpatient ketamine infusion for chronic pain and PTSD in military personnel
The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD: A Prospective Randomized Design
This study is testing if ketamine infusions can help military personnel with chronic pain and PTSD feel better compared to those who only receive magnesium.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Brooke Army Medical Center Federal |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06414356 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effects of outpatient ketamine infusion on chronic neuropathic pain and PTSD among military personnel. It involves 30 participants who will be randomized into three groups: one receiving moderate dose ketamine, another receiving moderate dose ketamine with magnesium, and a control group receiving magnesium only. Participants will complete self-reported questionnaires on pain and PTSD throughout the approximately 24-week study period. The study aims to provide evidence for the effectiveness of ketamine in managing neuropathic pain and associated comorbidities in this population.
Who should consider this trial
Good fit: Ideal candidates are active duty, veterans, or retirees aged 18-70 with chronic neuropathic pain lasting more than three months.
Not a fit: Patients with cognitive dysfunction, psychiatric illnesses involving psychosis, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for managing chronic neuropathic pain and PTSD in military personnel.
How similar studies have performed: Other studies have shown promising results with ketamine for pain management and PTSD, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Antonio, Texas
- Brooke Army Medical Center — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Margaux M Salas, PhD
- Email: margaux.m.salas.ctr@health.mil
- Phone: 210-473-7447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.