COMPLETED

Psilocybin-assisted Therapy for Phantom Limb Pain

Conditions

Phantom Limb Pain Psilocybin Psychedelic Therapy fMRI Pain Chronic Pain Psychedelics Hallucinogens Physiological Effects of Drugs Psychotropic Drugs

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This double-blind placebo-controlled pilot study seeks to investigate whether psilocybin can be safely administered to people with chronic phantom limb pain (PLP) in a supportive setting with close follow-up, and its effects on pain symptoms and other moods, attitudes, and behaviors. The investigators' primary hypotheses are that psilocybin is safe to administer in people with PLP and that it will reduce scores on measures of pain. The investigators will also assess a number of secondary measures related to the behavioral and neural responses to pain after psilocybin treatment.

Official Title

Behavioral and Neural Mechanisms Supporting Psilocybin-assisted Therapy for Phantom Limb Pain

Quick Facts

Study Start:2022-10-03

Study Completion:2024-03-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05224336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Between 18 and 75 years of age * Amputation of one extremity * Experience phantom limb pain of at least one month's duration and intensity of at least 3 out of 10 on the VAS * Able to fluently communicate in English * Agree to sign the consent and HIPPA authorization * Willing to refrain from taking serotonergic antidepressant medication during the study period * Willing to refrain from using any non-prescribed psychoactive drugs, including alcohol, within 24 hours before and after study drug administration * Agree not to use any nonprescription medications, herbal medications, or supplements during the week prior to each drug session unless an exception is approved by the study investigators * Willing to refrain from smoking or use of nicotine during the period from 8:00 am on the morning of the drug sessions until they are discharged to go home at the end of the end of the session * Able to remain in an MRI machine without sedation * Women of childbearing potential must agree to practice an effective means of birth control throughout the study, from screening to the final visit * Have a relative or friend who can provide/accompany transportation after the drug session * If pain is currently being treated with analgesic medications, the analgesic regimen must be stable for at least 2 weeks prior to enrollment, and the participant must agree not to change their use of analgesic medication without first consulting with the study investigators \[permissible analgesic medications are as follows: aspirin, acetaminophen, celecoxib, diflunisal, etodolac, fenoprofen, flubiprofen, gabapentin, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nalbumetone, naproxen, pregabalin, proxicam, sulindac, tolmetin, and valdecoxib. PRN use of OTC analgesic medications by participants is also permissible\] * Participants who are taking other medications acting as serotonin antagonists (e.g., cyclobenzaprine, odansetron), dopamine antagonists (e.g., metoclopramide, promethazine, prochlorperazine), dopamine agonists (e.g., levodopa, pramipexole, apomorphine), psychostimulants (e.g., modafinil, armodafinil, solriamfetol, methylphenidate, dexmethylphenidate, atomoxetine, dextroamphetamine, mixed amphetamine salts, lisdexamphetamine), anticholinergics (e.g., benzotropine, trihexyphenidyl, scopolamine, hypscyamine), or N-methyl-D-aspartate receptor antagonists (e.g., amantadine, memantine, ketamine) must be willing to discontinue those medications 1 week prior to each drug session	* Under the age of 18 or over the age of 75 * Pregnant or nursing females * Females of childbearing age who are sexually active but not using birth control * Phantom limb pain intensity \<3 out of 10 on the VAS * Presence of another type of chronic pain that cannot be differentiated from phantom limb pain by the participant * Amputation of more than one extremity * MRI related contraindications including pacemakers, metal implants, spinal cord stimulators etc. * Meet DSM-V criteria for bipolar disorder, schizophrenia, or other psychotic disorder * Have a first-degree relative (parent or full-sibling) with a history of bipolar disorder, schizophrenia, or other psychotic disorder * Judged to present a suicide risk * Not able to complete an MRI scan * Active substance use disorder (excluding tobacco and caffeine) * Subjects prescribed methadone or buprenorphine for any indication * Require concomitant treatment with efavirenz * Participants who are prescribed antidepressants or antipsychotics for an axis I diagnosis * Participants who are taking a serotonergic dietary supplement (e.g., 5-hydroxytryptophan, St. John's wort, SAM-e) * Participants with any neurological conditions resulting in altered perception or cognition (e.g., dementia, traumatic brain injury, mild cognitive impairment) \[with the exception of phantom limb syndrome and its sequelae (depression or anxiety)\] * Participants with a positive urine drug screen for amphetamines, barbiturates, buprenorphine, cocaine, methamphetamine, MDMA, methadone, opiates (morphine, oxycodone), or phencyclidine (PCP) * Have used psilocybin, psilocybin-containing mushrooms, or another serotonergic hallucinogen (e.g., LSD, mescaline, ayahuasca) for recreational purposes within the last 12 months * Require concomitant treatment with anti-psychotic medications (aripiprazole, asenapine, brexpiprazole, cariprazine, chlorpromazine, clozapine, fluphenazine, haloperidol, iloperidone, loxapine, mesoridazine, molindone, olanzapine, paliperidone, perphenazine, pimavanserin, pimozide, prochlorpromazine, quetiapine, risperidone, thioridazine, thiothixene, trifluperazine, or ziprasidone) * Require concomitant treatment with an antidepressant medication or other medications that act as MAO inhibitors or serotonin reuptake inhibitors (amitriptyline, amoxapine, bupropion, citalopram, clomipramine, desipramine, doxepin, duloxetine, escitalopram, fluoxetine, fluvoxamine, imipramine, isocarboxazid, levomilnacipram, maprotiline, milnacipram, mirtazapine, nefazodone, nortriptyline, paroxetine, phenelzine, protriptyline, selegiline, sertraline, tramadol, tranylcypromine, trazodone, trimipramine, venlafaxine, vilazodone, vortioxetine) \[trazodone ≤50mg/24hr for insomnia is allowed, but not within 48hr of the psilocybin session\] * Require concomitant treatment with medications known to inhibit UGT1A9 and UGT1A10 (e.g., diclofenac, probenecid, valproic acid) * Severe hearing or visual impairment * History of seizure disorder or epilepsy * History of migraine or other severe recurring headaches necessitating treatment by a neurologist or headache specialist * History of adverse reactions or intolerance to niacin or the rescue medications used in the study (benzodiazepines, antipsychotics, labetalol, nitroglycerin) * Presence of uncontrolled cardiovascular disease or uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg) * Require concomitant treatment with an antihypertensive medication * QTc prolongation (QTc \> 0.045 for man, QTc \> 0.047 for women) * Subjects with history of stroke, angina, clinically significant ECG abnormality (e.g. atrial fibrillation), or artificial heart valve * Participants with severe renal impairment (GFR \< 30 mL/min/1.73 m2) * Participants with any clinically significant lab abnormalities as determined by a physician on the study team * Myocardial infarction within the last 12 months * Participants who meet criteria for Child-Pugh class B or higher * Participants who are prescribed opioid medications * Participants taking other medications that may be associated with serotonin syndrome: carbamazepine, dextromethorphan, lithium, linezolid, buspirone * Evidence of severely compromised hepatic function

Inclusion Criteria

Exclusion Criteria

* Between 18 and 75 years of age
* Amputation of one extremity
* Experience phantom limb pain of at least one month's duration and intensity of at least 3 out of 10 on the VAS
* Able to fluently communicate in English
* Agree to sign the consent and HIPPA authorization
* Willing to refrain from taking serotonergic antidepressant medication during the study period
* Willing to refrain from using any non-prescribed psychoactive drugs, including alcohol, within 24 hours before and after study drug administration
* Agree not to use any nonprescription medications, herbal medications, or supplements during the week prior to each drug session unless an exception is approved by the study investigators
* Willing to refrain from smoking or use of nicotine during the period from 8:00 am on the morning of the drug sessions until they are discharged to go home at the end of the end of the session
* Able to remain in an MRI machine without sedation
* Women of childbearing potential must agree to practice an effective means of birth control throughout the study, from screening to the final visit
* Have a relative or friend who can provide/accompany transportation after the drug session
* If pain is currently being treated with analgesic medications, the analgesic regimen must be stable for at least 2 weeks prior to enrollment, and the participant must agree not to change their use of analgesic medication without first consulting with the study investigators \[permissible analgesic medications are as follows: aspirin, acetaminophen, celecoxib, diflunisal, etodolac, fenoprofen, flubiprofen, gabapentin, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nalbumetone, naproxen, pregabalin, proxicam, sulindac, tolmetin, and valdecoxib. PRN use of OTC analgesic medications by participants is also permissible\]
* Participants who are taking other medications acting as serotonin antagonists (e.g., cyclobenzaprine, odansetron), dopamine antagonists (e.g., metoclopramide, promethazine, prochlorperazine), dopamine agonists (e.g., levodopa, pramipexole, apomorphine), psychostimulants (e.g., modafinil, armodafinil, solriamfetol, methylphenidate, dexmethylphenidate, atomoxetine, dextroamphetamine, mixed amphetamine salts, lisdexamphetamine), anticholinergics (e.g., benzotropine, trihexyphenidyl, scopolamine, hypscyamine), or N-methyl-D-aspartate receptor antagonists (e.g., amantadine, memantine, ketamine) must be willing to discontinue those medications 1 week prior to each drug session

* Under the age of 18 or over the age of 75
* Pregnant or nursing females
* Females of childbearing age who are sexually active but not using birth control
* Phantom limb pain intensity \<3 out of 10 on the VAS
* Presence of another type of chronic pain that cannot be differentiated from phantom limb pain by the participant
* Amputation of more than one extremity
* MRI related contraindications including pacemakers, metal implants, spinal cord stimulators etc.
* Meet DSM-V criteria for bipolar disorder, schizophrenia, or other psychotic disorder
* Have a first-degree relative (parent or full-sibling) with a history of bipolar disorder, schizophrenia, or other psychotic disorder
* Judged to present a suicide risk
* Not able to complete an MRI scan
* Active substance use disorder (excluding tobacco and caffeine)
* Subjects prescribed methadone or buprenorphine for any indication
* Require concomitant treatment with efavirenz
* Participants who are prescribed antidepressants or antipsychotics for an axis I diagnosis
* Participants who are taking a serotonergic dietary supplement (e.g., 5-hydroxytryptophan, St. John's wort, SAM-e)
* Participants with any neurological conditions resulting in altered perception or cognition (e.g., dementia, traumatic brain injury, mild cognitive impairment) \[with the exception of phantom limb syndrome and its sequelae (depression or anxiety)\]
* Participants with a positive urine drug screen for amphetamines, barbiturates, buprenorphine, cocaine, methamphetamine, MDMA, methadone, opiates (morphine, oxycodone), or phencyclidine (PCP)
* Have used psilocybin, psilocybin-containing mushrooms, or another serotonergic hallucinogen (e.g., LSD, mescaline, ayahuasca) for recreational purposes within the last 12 months
* Require concomitant treatment with anti-psychotic medications (aripiprazole, asenapine, brexpiprazole, cariprazine, chlorpromazine, clozapine, fluphenazine, haloperidol, iloperidone, loxapine, mesoridazine, molindone, olanzapine, paliperidone, perphenazine, pimavanserin, pimozide, prochlorpromazine, quetiapine, risperidone, thioridazine, thiothixene, trifluperazine, or ziprasidone)
* Require concomitant treatment with an antidepressant medication or other medications that act as MAO inhibitors or serotonin reuptake inhibitors (amitriptyline, amoxapine, bupropion, citalopram, clomipramine, desipramine, doxepin, duloxetine, escitalopram, fluoxetine, fluvoxamine, imipramine, isocarboxazid, levomilnacipram, maprotiline, milnacipram, mirtazapine, nefazodone, nortriptyline, paroxetine, phenelzine, protriptyline, selegiline, sertraline, tramadol, tranylcypromine, trazodone, trimipramine, venlafaxine, vilazodone, vortioxetine) \[trazodone ≤50mg/24hr for insomnia is allowed, but not within 48hr of the psilocybin session\]
* Require concomitant treatment with medications known to inhibit UGT1A9 and UGT1A10 (e.g., diclofenac, probenecid, valproic acid)
* Severe hearing or visual impairment
* History of seizure disorder or epilepsy
* History of migraine or other severe recurring headaches necessitating treatment by a neurologist or headache specialist
* History of adverse reactions or intolerance to niacin or the rescue medications used in the study (benzodiazepines, antipsychotics, labetalol, nitroglycerin)
* Presence of uncontrolled cardiovascular disease or uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg)
* Require concomitant treatment with an antihypertensive medication
* QTc prolongation (QTc \> 0.045 for man, QTc \> 0.047 for women)
* Subjects with history of stroke, angina, clinically significant ECG abnormality (e.g. atrial fibrillation), or artificial heart valve
* Participants with severe renal impairment (GFR \< 30 mL/min/1.73 m2)
* Participants with any clinically significant lab abnormalities as determined by a physician on the study team
* Myocardial infarction within the last 12 months
* Participants who meet criteria for Child-Pugh class B or higher
* Participants who are prescribed opioid medications
* Participants taking other medications that may be associated with serotonin syndrome: carbamazepine, dextromethorphan, lithium, linezolid, buspirone
* Evidence of severely compromised hepatic function

Contacts and Locations

Study Locations (Sites)

University of California, San Diego

San Diego, California, 92093

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-03

Study Completion Date2024-03-07

Study Record Updates

Study Start Date2022-10-03

Study Completion Date2024-03-07

Terms related to this study

Keywords Provided by Researchers

Phantom Limb Pain
Psilocybin
Psychedelic Therapy
fMRI
Pain
Chronic Pain
Psychedelics
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs

Additional Relevant MeSH Terms

Phantom Limb Pain