Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
NCT07276542

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.

Led by The Ketamine Research Foundation · Updated on 2026-03-18

30

Participants Needed

4

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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.

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of phantom limb pain at the time of ketamine administration
  • Willingness to participate and follow up for about one year
  • Living within 50 miles of study sites: Bay Area, Los Angeles, Albuquerque, Sacramento
  • Signed and dated informed consent before any study procedures
  • If female, negative pregnancy test at screening and before ketamine doses
  • Sexually active females and male partners must use effective birth control during ketamine treatment and one week after
  • Agree to avoid alcohol, marijuana, nicotine, and other intoxicants for at least 24 hours before treatment
  • Normotensive as defined by blood pressure and heart rate limits after 5 minutes of rest
  • Not currently on medications that blunt ketamine's effects
  • Aged 18 to 65 years
  • No prior ketamine treatment for phantom limb pain
Not Eligible

You will not qualify if you...

  • Any clinically important disease or disorder that increases risk or affects study participation
  • Known psychotic illness, mania, significant neurologic disorders, elevated eye or brain pressure
  • Abnormal baseline liver or kidney lab tests
  • Cardiovascular disease, arrhythmias, or abnormal EKGs
  • Use of medications that might cause adverse reactions with ketamine
  • Use of theophylline, aminophylline, sympathomimetics, or vasopressin
  • Daytime use of benzodiazepines unless dosage is low; nighttime use only if not sedating
  • Use of long-acting opioids like methadone or extended-release opioids
  • Opioid use over 50 mg/day morphine equivalent within one week of ketamine start
  • Positive urine drug screen for ketamine, cocaine, methamphetamine, PCP, or other substances of abuse
  • Recent use of THC less than 3 days before ketamine sessions
  • No increases or additions of opioids or other medications for phantom limb pain during the study
  • Daily alcohol use exceeding 2 standard drinks
  • Use of stimulants within 5 to 12 hours before ketamine sessions

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Shamynds

Sacramento, California, United States, 95818

Actively Recruiting

2

Ketamine Research Foundation

San Anselmo, California, United States, 94960

Actively Recruiting

3

Mystic Health

Santa Monica, California, United States, 90403

Actively Recruiting

4

Lisa Feierman MD

Albuquerque, New Mexico, United States, 87109

Actively Recruiting

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Research Team

P

Philip E Wolfson, MD

CONTACT

G

Gabriel Klapman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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