Outpatient Ketamine for Chronic Neuropathic Pain and PTSD
This study is looking at how outpatient ketamine infusions might help military members, veterans, and retirees who have chronic neuropathic pain (nerve pain lasting a long time) and PTSD (post-traumatic stress disorder). We are testing ketamine alone, ketamine combined with magnesium sulfate, or magnesium sulfate alone. You could join if you are 18-70 years old, have chronic neuropathic pain for at least 3 months, and have not used ketamine in the past year. The study aims to see if these treatments improve your pain levels, how much pain interferes with your daily life, and your overall life satisfaction. This is a pilot study with 30 participants.
- Study design
- This is a pilot study with 30 participants who will be randomly assigned to one of three treatment groups. The study is interventional, meaning participants will receive specific treatments.
- What's involved
- You would receive intravenous infusions for 4 hours each day, with the number of treatments per week decreasing over 6 weeks. There will also be booster treatments at week 10 and week 24. You will complete self-reported pain and PTSD questionnaires throughout the approximately 24-week study period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain and life satisfaction will be measured for up to 32 weeks after the study begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
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What this trial measures
- Defense and Veterans Pain Rating Score (DVPRS)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.
- Brief Pain Inventory Scale (BPI)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.
- Life Satisfaction Questionnaire (LiSAT)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.
- Post-traumatic Stress Disorder Checklist (PCL-5)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. * 0-31: Subclinical range (minimal to no PTSD symptoms) * 32-37: Mild PTSD symptoms * 38-43: Moderate PTSD symptoms * 44 and above: Severe PTSD symptoms
- The Patient-Reported Outcomes Measurement Information System (PROMIS 29+2)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.
- Patient Health Questionnaire-9 (PHQ-9)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: 1. Assign a score from 0 to 3 for each question based on the response: * "Not at all" = 0 * "Several days" = 1 * "More than half the days" = 2 * "Nearly every day" = 3 2. Sum the scores for all nine questions to obtain a total score, which can range from 0 to 27. Interpretation of the total PHQ-9 score is as follows: * 0-4: Minimal depression symptoms * 5-9: Mild depression symptoms * 10-14: Moderate depression symptoms * 15-19: Moderately severe depression symptoms * 20-27: Severe depression symptoms
- Generalized Anxiety Disorder ScaleUp 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. * "Not at all" = 0 * "Several days" = 1 * "More than half the days" = 2 * "Nearly every day" = 3 The sum of the scores for all seven questions obtain a total score, which can range from 0 to 21. Interpretation of the total GAD-7 score is as follows: * 0-4: Minimal anxiety symptoms * 5-9: Mild anxiety symptoms * 10-14: Moderate anxiety symptoms * 15-21: Severe anxiety symptoms