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New treatment option for Phantom Limb Syndrome With Pain
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.
ClinicalTrials.gov ID: NCT07276542
What this study is testing
What is IM ketamine in dose finding and then continuation?
IM ketamine in dose finding and then continuation is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for phantom limb syndrome with pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- 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...
- Patient agrees to withhold alcohol, marijuana, nicotine products, and any other intoxicants for at least 24 hours
You likely can't join if
- Exclusion Criteria
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of...
- Vulnerable persons are Excluded from the study. This includes people with known psychotic illness, mania, significant neurologic disorders, elevated...
- Exclusion of people with abnormal baseline hepatic and renal lab tests.
- Exclusion of people with cardiovascular disease, arrythmias, or abnormal EKGs.
- The presence of any medication that might cause an adverse reaction with ketamine.
See the full eligibility criteria
- 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...
- 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 \ 110 bpm.
- Not on Medications that would blunt ketamine's effects
- 18-65
- No prior history of treatment with ketamine for PLP.
- Exclusion Criteria
- 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...
- Vulnerable persons are Excluded from the study. This includes people with known psychotic illness, mania, significant neurologic disorders, elevated intraocular and or intracranial pressures
- Exclusion of people with abnormal baseline hepatic and renal lab tests.
- Exclusion of people 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: Theophylline Or Aminophyline...
- Sympathomimetics And Vasopressin-Excluded
- Benzodiazepines-PLP patients may be on benzodiazepines or other anxiolytic medications, people will be asked to suspend daytime use of these whenever possible recognizing that anxiety is an often present symptom within...
- Opioid Analgesics -PLP people 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...
- people on long-acting opioids such as methadone or extended-release opioids are excluded.
- people with opioid use 50 mg/day MME (morphine milliequivalents) within 1 week of initial ketamine administration are excluded.
- people with +UDS (urine drug screen) for ketamine, cocaine, methamphetamine, PCP, or other substances of abuse are excluded.
- people 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: people 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...
- Or Other CNS Depressants-gabapentin may well be prescribed for patients with PLP as is true for pregabalin, Whenever possible people will be asked to withhold these for at least 4 hours prior and not resume for at least...
- Alcohol-Daily use exceeding 2 US Standard drinks. No alcohol use in 24 hours preceding a ketamine session.
- Stimulants-people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- San Anselmo, California, United States
- Santa Monica, California, United States
- Albuquerque, New Mexico, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; San Anselmo, California, United States; Santa Monica, California, United States; Albuquerque, New Mexico, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.