Phantom Limb Syndrome With PainPhase 2/3PLPNCT07276542
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.
A Phase 2/3 study testing IM ketamine in dose finding and then continuation in people with Phantom Limb Syndrome With Pain, run by The Ketamine Research Foundation at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phantom Limb Syndrome With Pain
- What is being tested?
- IM ketamine in dose finding and then continuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jan 2026to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Systolic BP> 150 mmHg.
- Diastolic BP> 105 mmHg.
- HR <50 or >110 bpm.
- Not on Medications that would blunt ketamine's effects
- 18-65
- No prior history of treatment with ketamine for PLP.
- -
- -
Who cannot join
- 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
- Exclusion of subjects with abnormal baseline hepatic and renal lab tests.
- Exclusion of subjects with cardiovascular disease, arrythmias, or abnormal EKGs.
- 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:
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- 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.
- All concomitant medications, including type and amount, will be recorded by study participants in their daily diaries and reviewed by study staff before each treatment session and any scheduled telephone calls.
- Participants will not receive opioids 4 hours before or after ketamine administration.
- Laboratory assessments: Subjects with abnormal baseline hepatic or renal lab tests are to be excluded. In addition, obtain the following laboratory tests at the following times: CBC, hepatic and renal labs at 3 months and 6 months. Follow-up abnormal laboratory values.
- Or Other CNS Depressants-gabapentin may well be prescribed for patients with PLP as is true for pregabalin, Whenever possible subjects will be asked to withhold these for at least 4 hours prior and not resume for at least 4 hours after the last administration of ketamine. This is consistent with two half-lives of ketamine
- Alcohol-Daily use exceeding 2 US Standard drinks. No alcohol use in 24 hours preceding a ketamine session.
- Stimulants-Subjects will be asked to withhold stimulants for 5-12 hours prior to administration of ketamine depending on the duration of action of the particular preparation and not resume until the next day after treatment.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Lisa Feierman MD
Albuquerque, New Mexico, 87109
Lisa Feierman, MD, (505) 450-7626, lisafeierman@gmail.com
- Recruiting
Shamynds
Sacramento, California, 95818
Alya Ahmad, MD, 916 538 6498, Aahmad@shamynds.com
- Recruiting
Ketamine Research Foundation
San Anselmo, California, 94960
Philip E Wolfson, MD, 415-785-3797, ketamine.research@gmail.com
Gabe Klapman, MD
- Recruiting
Mystic Health
Santa Monica, California, 90403
Houman Farzin, MD, 310.526.7619, info@mystic.health
Thais Sallis Arroyo, MD, 310.526.7619, thais@mystic.health
About this study
Official title: Phantom Limb Pain Ketamine Treatment Study
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).
Read more
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
- Being tested
- IM ketamine in dose finding and then continuation
- Keywords
- Phantom Limb Pain, PLP. ketamine, ketamine and pain, ketamine assisted psychotherapy
- Medical subject headings
- Phantom Limb, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM ketamine in dose finding and then continuationDrug
Intermittent ketamine treatment based on response
| Study group | Role | What they receive |
|---|---|---|
| PLP Ketamine Intervention | Experimental | Not described Receives: Drug: IM ketamine in dose finding and then continuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Questionnaire SF-MPQ-2
A complex assassement measure for complex pain presentations
Measured: 6 months per subject with a 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start15 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb Syndrome With PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ketamine Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276542
- Sponsor's protocol ID
- KRF-PLP
- Other IDs
- IND 175124
- Acronym
- PLP
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcome data for each participant
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phantom Limb Pain Ketamine Treatment Study
- ClinicalTrials.gov ID
- NCT07276542
- Acronym / sponsor ID
- PLP / KRF-PLP
- Conditions
- Phantom Limb Syndrome With Pain
- Keywords
- Phantom Limb Pain, PLP. ketamine, ketamine and pain, ketamine assisted psychotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Ketamine Research FoundationUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| PLP Ketamine Intervention | Experimental | Drug: IM ketamine in dose finding and then continuation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (23 listed)
- 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
- Exclusion of subjects with abnormal baseline hepatic and renal lab tests.
- Exclusion of subjects with cardiovascular disease, arrythmias, or abnormal EKGs.
- The presence of any medication that might cause an adverse reaction with ketamine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IM ketamine in dose finding and then continuationIntermittent ketamine treatment based on response | Drug | PLP Ketamine Intervention |
Primary outcome
McGill Pain Questionnaire SF-MPQ-2
Time frame: 6 months per subject with a 12 month follow-up
A complex assassement measure for complex pain presentations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Parent non-profit organization for study--SponsorLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Outcome data for each participant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IM ketamine in dose finding and then continuation in people with Phantom Limb Syndrome With Pain, run by The Ketamine Research Foundation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip E Wolfson, MD (+1-415-785-3797, ketamine.research@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McGill Pain Questionnaire SF-MPQ-2 (time frame: 6 months per subject with a 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.