Clinical Trial Exploring the Outpatient Treatment of Phantom Limb Pain With Ketamine Administration in a Six Month Study With a Minimum Remission Period of 7 Days Between Treatment Session. 25-30 Subjects With an Ongoing History of Significant PLP.--FDA and IRB Approved.

NCT07276542 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: KRF-PLPIND 175124
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

Must be living Within a 50 mile radius of our study sites: Bay Area, Los Angeles, Albuquerque, Sacramento, Los Angeles An anecdotal report with administration of ketamine in a non-clinical setting providing and sustained remission of symptoms after 6 years has furthered the interest in ascertaining if ketamine might indeed be a successful intervention. (See Wolfson and Barocchi). Ketamine has shown benefit in a variety of pain and neurological disorders. Its exploration for these continues and there appears to be an expanding use of ketamine for difficult to treat syndromes. Phantom limb pain occurs in over 50% of amputees, tends to be immediate in onset, but may occur at a later time. It is often excruciating, with a high frequency of episodes that tend to diminish with time-- variably. Its treatment is reliant on opioids and other pain medications usually with limited results. Acupuncture has been minimally explored with no clear results. Our study aims at clarifying ketamine's status for this particular disorder. This is an off-label use of RS ketamine for clinical purposes. Each subject of the 25-30 enrolled in the study will have up to 16 ketamine sessions over six months time, Subjects will be continued in the study if the partial or complete remission period is seven days or more, If less, subjects will be considered to have not adequately responded to the protocol's provision of IM ketamine. Dosage of ketamine will be determined in the initial session with a dosage escalation protocol with an upper limit of 120mg--that limit not to be exceeded for the duration of each subject's participation in the study.. The time for a succeeding session of ketamine is variable depending on response and therefore the duration of the remission--not to be less than 7 days as the minimum consideration for a response, Subjects will receive support throughout their sessions and these will be conducted with integration following the medication, much as in the ketamine assisted psychotherapy model practiced by us as clinicians. As PLP has its emotional impact as well as its complex pain presentation, these parameters will be followed with a variety of assessment tools. The nature of each subjects PLP syndrome will be analyzed in detail as well as the particularity of responses to the elements of the syndrome.. Living Within a 50 mile radius of our study sites: Bay Area, Los Angeles, Albuquerque, Sacramento, Los Angeles

Conditions

Phantom Limb Syndrome With Pain

Keywords

Phantom Limb Pain, PLP. ketamine, ketamine and pain, ketamine assisted psychotherapy

Outcome Measures

Primary Outcomes (1)

• McGill Pain Questionnaire SF-MPQ-2

  A complex assassement measure for complex pain presentations

  6 months per subject with a 12 month follow-up

Study Arms (1)

PLP Ketamine Intervention

EXPERIMENTAL

Drug: IM ketamine in dose finding and then continuation

Interventions

IM ketamine in dose finding and then continuation DRUG

Intermittent ketamine treatment based on response

PLP Ketamine Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of phantom limb pain at the time of administration of ketamine.
• Willingness to participate in the study and follow-up over a year long period. Living Within a 50 mile radius of our study sites: Bay Area, Los Angeles, Albuquerque, Sacramento, Los Angeles
• Provision of signed and dated, written informed consent prior to any study-specific procedures.
• If female, must have a negative pregnancy test at Screening and any subsequent administration of ketamine. Sexually active females and male partners must be using adequate birth control measures during the duration of the study when ketamine will be administered and for one week after the last administration of ketamine.
• Patient agrees to withhold alcohol, marijuana, nicotine products, and any other intoxicants for at least 24 hours
• Normotensive-defined as Abnormal VS, after 5 minutes supine rest at Screening or on Day -1, defined as any of the following:
• Systolic BP\> 150 mmHg.
• Diastolic BP\> 105 mmHg.
• HR \<50 or \>110 bpm.
• Not on Medications that would blunt ketamine's effects
• No prior history of treatment with ketamine for PLP.

You may not qualify if:

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
• Vulnerable persons are Excluded from the study. This includes subjects with known psychotic illness, mania, significant neurologic disorders, elevated intraocular and or intracranial pressures
• The presence of any medication that might cause an adverse reaction with ketamine.
• The Ketalar Label as cited by FDA includes Drug Interactions particular to anesthesia and the use of IV boluses at far higher dosages than those used in our study. In Review of these:
• Theophylline Or Aminophyline --Excluded
• Sympathomimetics And Vasopressin-Excluded
• Benzodiazepines-PLP patients may be on benzodiazepines or other anxiolytic medications, Subjects will be asked to suspend daytime use of these whenever possible recognizing that anxiety is an often present symptom within the PLP complex. Recognition of a possible increase in sedation due to the concomitant presence of a benzodiazepine with ketamine may lead to a lowering of the ketamine dosage. Nighttime use of a benzodiazepine for treatment of insomnia will not be discontinued unless the dosage is high and considered to have a sedating effect on the degree of ketamine's sedation the next day. The length of time between nighttime use and administration of ketamine during the day should diminish the effects of the nighttime medication.
• Opioid Analgesics -PLP subjects most likely will have been or will be receiving opiates for pain relief, Concomitant use of ketamine and opiates in outpatient settings for analgesia is a common and accepted practice. Withdrawing opiates for ketamine administered in subanesthetic doses is not appropriate. In several studies ketamine has been shown to reduce the amount of opioids needed for analgesia, It is the hope of this study that successful treatment with ketamine will enable reduction or cessation of opioid use, In our vast clinical experience, we have treated with ketamine at subanesthetic doses patients on opiates without adverse effects.
• Subjects on long-acting opioids such as methadone or extended-release opioids are excluded.
• Subjects with opioid use 50 mg/day MME (morphine milliequivalents) within 1 week of initial ketamine administration are excluded.
• Subjects with +UDS (urine drug screen) for ketamine, cocaine, methamphetamine, PCP, or other substances of abuse are excluded.
• Subjects who have used THC may be enrolled but must have abstained from THC for at least 3 days prior to each ketamine session
• Concomitant medications:
• Oral IR (immediate release) opioid mu agonists up to 50 mg/day MME (morphine milliequivalents) are allowed (e.g., hydromorphone, oxycodone, morphine, and hydrocodone).
• No increases of any opioids or other concomitant medications, or addition of new medications or therapies for PLP will be allowed during the study.

Sponsors & Collaborators

• The Ketamine Research Foundation: lead

Study Sites (4)

Shamynds

Sacramento, California, 95818, United States

RECRUITING

Ketamine Research Foundation

San Anselmo, California, 94960, United States

RECRUITING

Mystic Health

Santa Monica, California, 90403, United States

RECRUITING

Lisa Feierman MD

Albuquerque, New Mexico, 87109, United States

RECRUITING

Related Links

• Parent non-profit organization for study--Sponsor

MeSH Terms

Conditions

Phantom Limb; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Philip E Wolfson, MD

CONTACT

+1-415-785-3797; ketamine.research@gmail.com

Gabriel Klapman, MD

CONTACT

415-785-3797; ketamine.research@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Provision of IM ketamine in a protocol with minimal time for response of 7 days and assessment of need for treatment over six months' time

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 11, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (4)