Clinical trial for Neuropathic Pain
Official title The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD
ClinicalTrials.gov ID: NCT06414356
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for neuropathic pain.
Also referred to as Ketalar.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study wants to see if giving ketamine through an IV helps reduce nerve pain and PTSD symptoms in veterans.
- Who it's for
- The study is looking for military veterans who have chronic nerve pain and PTSD.
- What's involved
- Participants will get an IV infusion of ketamine, ketamine with magnesium, or just magnesium. They will also fill out questionnaires about their pain and mental health.
- Time commitment
- The study lasts about 24 weeks and requires regular visits to complete the infusions and questionnaires.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Active Duty, Veterans, and retirees
- Ketamine naïve for 1 year
You likely can't join if
- 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
See the full eligibility 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...
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.