- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06414356
The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD
The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD: A Prospective Randomized Design
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Margaux M Salas, PhD
- Phone Number: 210-473-7447
- Email: margaux.m.salas.ctr@health.mil
Study Contact Backup
- Name: Kevin C Peterson, MD
- Phone Number: 210-916-7331
- Email: kevin.c.peterson3.mil@health.mil
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 |
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)
Other Names:
|
Experimental: Moderate dose ketamine + magnesium sulfate
0.50 mg/kg/hr ketamine + 750 mg/hr Mg
|
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)
Other Names:
|
Active Comparator: Magnesium sulfate
750 mg/hr
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defense and Veterans Pain Rating Score (DVPRS)
Time Frame: Up to 32 weeks
|
The DVPRS is a self-report instrument used to assess pain intensity in military personnel, veterans, and other military populations. It was specifically developed for individuals with military backgrounds and is often used in clinical settings to monitor pain levels and treatment effectiveness. The DVPRS consists of a Numeric Rating Scale (NRS) from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Respondents rate their pain intensity by selecting the number that best corresponds to their current level of pain. The DVPRS questionnaire will be used to determine how daily pain levels change throughout the study. Three questions assess current pain, worst pain in past 7 days, and worse pain in past month. These three questions are separately assessed for pain. |
Up to 32 weeks
|
Brief Pain Inventory Scale (BPI)
Time Frame: Up to 32 weeks
|
The BPI is a 15-item self-report measure of pain intensity and pain interference with daily life.
The Brief Pain Inventory (BPI) is scored separately for its two main sections: Pain Severity and Pain Interference.
It includes questions about the intensity of pain at its "worst," "least," "average," and "right now" over the past week.
Respondents rate the severity of pain on a numeric rating scale (NRS) from 0 to 10.
The Pain Interference section evaluates the extent to which pain interferes with various aspects of the individual's life.
The Pain Severity Score is calculated with the average score of the four items assessing pain severity.
This average represents the overall pain severity experienced by the individual.
This questionnaire will be used to determine how current pain levels change throughout the study.
|
Up to 32 weeks
|
Life Satisfaction Questionnaire (LiSAT)
Time Frame: Up to 32 weeks
|
The LiSAT is a self-report instrument used to assess overall satisfaction with various life domains. It provides a comprehensive assessment of life satisfaction. The LiSAT consists of items that assess satisfaction across several domains of life, such as: work, leisure activities and free time, economy, relationships with friends, relationships with relatives, sexual life/partner relationship, physical health, psychological health, and safety. Respondents rate their satisfaction within each domain using a Likert-type scale, with response options ranging from "very dissatisfied" to "very satisfied". Each response is assigned a numerical value. After completing the questionnaire, scores for each domain are summed or averaged to obtain a total score or subscale scores representing satisfaction within specific life domains. Higher scores indicate greater satisfaction within the respective domain. |
Up to 32 weeks
|
Post-traumatic Stress Disorder Checklist (PCL-5)
Time Frame: Up to 32 weeks
|
The PTSD Checklist (PCL-5) is a widely used self-report measure used to assess symptoms of post-traumatic stress disorder (PTSD). It consists of 20 items that correspond to the Diagnostic and Statistical criteria for PTSD. Respondents rate the frequency of symptoms over the past month on a scale from 0 (Not at all) to 4 (Extremely). There are different cutoff scores used for diagnosing PTSD or assessing the severity of symptoms, but higher total scores generally indicate more severe PTSD symptoms.
|
Up to 32 weeks
|
The Patient-Reported Outcomes Measurement Information System (PROMIS 29+2)
Time Frame: Up to 32 weeks
|
The Patient-Reported Outcomes Measurement Information System (PROMIS 29+2) profile is a comprehensive assessment tool used to evaluate various aspects of health-related quality of life (HRQOL) across physical, mental, and social domains. Respondents rate their experiences over the past 7 days using a Likert-type scale, with response options ranging from 1 to 5. Higher scores indicate greater impairment or severity of symptoms, depending on the specific domain being assessed. For scoring, each item is scored based on the response provided by the respondent. Scores for items within each domain are aggregated to calculate domain scores. The questionnaire provides individual scores for each domain assessed, allowing for a comprehensive profile of the respondent's health-related quality of life. Total for each domain is assessed. Higher scores typically indicate greater impairment or symptom severity, while lower scores indicate better functioning or fewer symptoms. |
Up to 32 weeks
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Up to 32 weeks
|
The Patient Health Questionnaire-9 (PHQ-9) is a widely used screening tool for depression. It consists of nine questions that ask about symptoms experienced over the past two weeks. Each question is scored on a scale from 0 to 3, with responses ranging from "not at all" to "nearly every day." To score the PHQ-9:
Interpretation of the total PHQ-9 score is as follows:
|
Up to 32 weeks
|
Generalized Anxiety Disorder Scale
Time Frame: Up to 32 weeks
|
The Generalized Anxiety Disorder 7-item scale (GAD-7) is a widely used screening tool designed to assess the severity of generalized anxiety disorder (GAD) symptoms. It consists of seven questions that ask about symptoms experienced over the past two weeks. Each question is scored on a scale from 0 to 3, with responses ranging from "not at all" to "nearly every day." To score the GAD-7 questions are rated from 0 to 3.
Interpretation of the total GAD-7 score is as follows:
|
Up to 32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool
Time Frame: Up to 32 weeks
|
The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool is a comprehensive screening instrument used to assess an individual's substance use across multiple categories.
It's designed to provide a thorough evaluation of substance use behaviors, including tobacco, alcohol, prescription medications, and other substances.
|
Up to 32 weeks
|
Richmond Agitation-Sedation Scale (RASS)
Time Frame: Up to 26 weeks
|
The Richmond Agitation-Sedation Scale (RASS) measures a patient's agitation or sedation level. The scale ranges from -5 to +4: Based on the observed behavior, assign a numerical score on the RASS scale:
|
Up to 26 weeks
|
Clinician-Administered Dissociative States Scale (CADSS)
Time Frame: Up to 26 weeks
|
The CADSS is a tool used to assess dissociative states induced by drugs or other factors.
The Clinician-Administered Dissociative States Scale (CADSS) is used to measure the severity of dissociative states induced by drugs or other factors.
Each item on the scale is rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely).
The total score is calculated by summing up the scores for all items on the scale.To score the CADSS, each item is rated on a 5-point Likert scale (0 to 4) based on the severity of the symptom described.
The total score is summed for all 23 items to obtain the total CADSS score.
This total score ranges from 0 to 92, with higher scores indicating greater severity of dissociative symptoms.
|
Up to 26 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Orhurhu V, Orhurhu MS, Bhatia A, Cohen SP. Ketamine Infusions for Chronic Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2019 Jul;129(1):241-254. doi: 10.1213/ANE.0000000000004185.
- Urits I, Jung JW, Amgalan A, Fortier L, Anya A, Wesp B, Orhurhu V, Cornett EM, Kaye AD, Imani F, Varrassi G, Liu H, Viswanath O. Utilization of Magnesium for the Treatment of Chronic Pain. Anesth Pain Med. 2021 Feb 6;11(1):e112348. doi: 10.5812/aapm.112348. eCollection 2021 Feb.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Ketamine
- Magnesium Sulfate
Other Study ID Numbers
- 954942
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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