PsilocybinPhase 2NCT07227909
NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy
A Phase 2 study testing Psilocybin (drug) in people with Psilocybin and Neuropathy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psilocybin, Neuropathy
- What is being tested?
- Psilocybin (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2026to 31 Jan 2031
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of another primary malignancy, except for:
- Malignancy treated with curative intent and no active disease for ≥ 5 years before the first dose of study drug, with low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Clinically significant suicidality or high risk of completed suicide defined as:
- Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline
Show all 65Show fewer
- Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts
- Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self- injurious behavior
- History of bipolar disorder, psychosis (including a history of schizophrenia).
- Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.
- Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.
- ECG with QTc > 450.
- Participants with non-MRI compatible metal implants.
- Asymptomatic ALT or AST elevations >/= 5X upper limit of normal, symptomatic ALT or AST elevations >/= 2X upper limit of normal, or total bilirubin >/= 2X upper limit of normal.
- Uncontrolled diabetes Mellitus with hemoglobin A1c > 8.5%
- The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstaining from intercourse with the opposite sex) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Vulnerable populations, including children and cognitively impaired participants, will not be enrolled in this study.
- Participants with brain metastases.
- Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) blood pressure >180/120mmHG, HR >110 bpm. Of note, we will repeat vital signs for subjects with high initial reading and average three readings to determine eligibility criteria in such cases to account for normal variability in vital sign and "white coat hypertension."
- Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial.
- Some examples include:
- Uncompensated congestive heart failure
- Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval > 450)
- Recent acute myocardial infarction or evidence of ischemia
- Malignant hypertension
- Congenital long QT syndrome
- Acute renal failure
- Severe hepatic impairment
- Respiratory failure
- Significant central nervous system (CNS) pathology. Some examples include:
- Primary or secondary cerebral neoplasm on imaging
- Epilepsy and any history of seizure (regardless of if related to epilepsy) except for a onetime febrile seizure in childhood
- History of stroke in the past 3 years
- Untreated cerebral aneurysm
- Dementia
- Ongoing delirium of any kind (including with or without psychosis) in which subjects would not have the capacity to participate in the study.
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation.
- Examples include:
- Agitation
- Violent behavior
- Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year
- Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. >22 lifetime uses iii. History of diagnosed hallucinogen persisting perception disorder (HPPD)
- Concurrent Medications
- Antidepressants
- Centrally-acting serotonergic agents (e.g., MAO inhibitors)
- Antipsychotics (e.g., first and second generation)
- Mood stabilizers (e.g., lithium, valproic acid)
- Aldehyde dehydrogenase inhibitors (e.g., disulfiram)
- Significant inhibitors of UGT 1A0 or UGT 1A10
- serotonin-acting dietary supplements (such as 5-hydroxytryptophan or St. John's wort)
- efavirenz
- Other Medications Listed in Section 3.1 19. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).
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- Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.
- Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.
- Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.
- Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use 72 hours prior to dosing and until 12 hours after dosing.
- 20. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin
- Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.
- Have an allergy or intolerance to any of the materials contained in either drug product Be enrolled in another clinical trial assessing intervention(s) for prevention or treatment of any pain-related symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo.
Read the detailed description
Primary Objective
- To assess the efficacy of psilocybin in the prevention or mitigation of chemotherapy-induced peripheral neuropathy (CIPN) in individuals undergoing adjuvant neurotoxic chemotherapy (i.e., taxanes, platinum-based compounds) for breast, colorectal, and head \& neck cancers. The primary endpoint is the proportion of participants with a ≥25% increase (worsening) from baseline to Week 12 on the EORTC QLQ-CIPN20 sensory subscale.
The primary comparison is 25 mg psilocybin vs pooled control (standard of care + 1 mg subperceptual psilocybin), tested two-sided at α=0.05. If significant, two confirmatory pairwise tests (25 mg vs SOC; 25 mg vs 1 mg) will be performed with Hochberg multiplicity control.
Hypothesis: Prophylactic psilocybin administered in four doses (two pre-chemotherapy and two during chemotherapy) will reduce the severity of CIPN as measured by the proportion of participants reporting a 25% or greater increase in CIPN on the EORTC QLQ-CIPN20 sensory subscale compared to placebo or SOC.
Secondary Objectives
- Determine whether prophylactic psilocybin reduces rates of dose-liming modifications to chemotherapy as result of peripheral neurotoxicity. Dose modifications are defined by either a change in frequency or reduced chemotherapy dose during the 12-week study period. Dose modification decisions will be made by the participant's independent, primary clinician.
- Determine whether prophylactic psilocybin decreases incidence and severity of CIPN as measured by the NCI-CTCAE criteria
- Determine whether psilocybin-assisted psychotherapy improves measures of quality of life (e.g., sleep, pain, fatigue, functional status) and psychosocial well-being (e.g., mental health, finding meaning, and post-traumatic growth), as measured by the following: PROMIS-10, PROMIS-A, PROMIS-D, FACT-Cog, PSQI, BFI, MDASI, MEQ30 (mystical experience), Flourishing scale.
- Determine whether psilocybin-assisted psychotherapy improves functional status per clinicianrated outcome measures.
- Assess the effects of psilocybin-assisted psychotherapy on all-cause cancer treatment adherence determined by the likelihood that participants will follow the prescribed treatment (adherence) and continue the treatment for the duration prescribed (persistence) for these maintenance therapies.
- Conditions
- Psilocybin, Neuropathy
- Being tested
- Psilocybin (drug), Standard of Care (SOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (drug)Drug
Given by po 25 mg
Psilocybin (drug)Drug
Given by po 1mg
Standard of Care (SOC)Other
No drug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Two supervised oral doses 1 week apart prior to chemotherapy cycle 1 (Day 7 and Day 14), followed by two monthly supervised doses prior to chemotherapy cycles 2 and 3 (Day 42 and Day 70); total 4 doses. Receives: Drug: Psilocybin (drug) |
| Arm B | Experimental | Subperceptual dosing every other day for 2 weeks during the pre-chemotherapy run-in (mailed 7×1 mg capsules in tamperevident packaging) prior to the first three cycles as above (21 total doses) Receives: Drug: Psilocybin (drug) |
| Arm C | Experimental | Standard of Care: Chemotherapy and supportive care per institutional guidelines; no study drug. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start4 Nov 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsilocybinStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Usona Institute
- Responsible party
- Sponsor
- Investigators
- Moran Amit, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227909
- Sponsor's protocol ID
- 2025-1361
- Other IDs
- NCI-2025-08499
- Status last verified
- Oct 2026
- First submitted
- 12 Nov 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy
- ClinicalTrials.gov ID
- NCT07227909
- Acronym / sponsor ID
- 2025-1361
- Conditions
- Psilocybin, Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Usona Institute
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 13 Nov 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.
To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo.
Detailed description
Primary Objective
- To assess the efficacy of psilocybin in the prevention or mitigation of chemotherapy-induced peripheral neuropathy (CIPN) in individuals undergoing adjuvant neurotoxic chemotherapy (i.e., taxanes, platinum-based compounds) for breast, colorectal, and head \& neck cancers. The primary endpoint is the proportion of participants with a ≥25% increase (worsening) from baseline to Week 12 on the EORTC QLQ-CIPN20 sensory subscale.
The primary comparison is 25 mg psilocybin vs pooled control (standard of care + 1 mg subperceptual psilocybin), tested two-sided at α=0.05. If significant, two confirmatory pairwise tests (25 mg vs SOC; 25 mg vs 1 mg) will be performed with Hochberg multiplicity control.
Hypothesis: Prophylactic psilocybin administered in four doses (two pre-chemotherapy and two during chemotherapy) will reduce the severity of CIPN as measured by the proportion of participants reporting a 25% or greater increase in CIPN on the EORTC QLQ-CIPN20 sensory subscale compared to placebo or SOC.
Secondary Objectives
- Determine whether prophylactic psilocybin reduces rates of dose-liming modifications to chemotherapy as result of peripheral neurotoxicity. Dose modifications are defined by either a change in frequency or reduced chemotherapy dose during the 12-week study period. Dose modification decisions will be made by the participant's independent, primary clinician.
- Determine whether prophylactic psilocybin decreases incidence and severity of CIPN as measured by the NCI-CTCAE criteria
- Determine whether psilocybin-assisted psychotherapy improves measures of quality of life (e.g., sleep, pain, fatigue, functional status) and psychosocial well-being (e.g., mental health, finding meaning, and post-traumatic growth), as measured by the following: PROMIS-10, PROMIS-A, PROMIS-D, FACT-Cog, PSQI, BFI, MDASI, MEQ30 (mystical experience), Flourishing scale.
- Determine whether psilocybin-assisted psychotherapy improves functional status per clinicianrated outcome measures.
- Assess the effects of psilocybin-assisted psychotherapy on all-cause cancer treatment adherence determined by the likelihood that participants will follow the prescribed treatment (adherence) and continue the treatment for the duration prescribed (persistence) for these maintenance therapies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Psilocybin (drug)Two supervised oral doses 1 week apart prior to chemotherapy cycle 1 (Day 7 and Day 14), followed by two monthly supervised doses prior to chemotherapy cycles 2 and 3 (Day 42 and Day 70); total 4 doses. |
| Arm B | Experimental | Drug: Psilocybin (drug)Subperceptual dosing every other day for 2 weeks during the pre-chemotherapy run-in (mailed 7×1 mg capsules in tamperevident packaging) prior to the first three cycles as above (21 total doses) |
| Arm C | Experimental | Other: Standard of Care (SOC)Standard of Care: Chemotherapy and supportive care per institutional guidelines; no study drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (65 listed)
- History of another primary malignancy, except for:
- Clinically significant suicidality or high risk of completed suicide defined as:
- History of bipolar disorder, psychosis (including a history of schizophrenia).
- Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.
- Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.
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 |
|---|---|---|
| Psilocybin (drug)Given by po 25 mg | Drug | Arm A |
| Psilocybin (drug)Given by po 1mg | Drug | Arm B |
| Standard of Care (SOC)No drug | Other | Arm C |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 3 Nov 2026.
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The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
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PRoMiSS: Psilocybin and the Role of Music in Set and Setting
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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.
Moran Amit, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin (drug) in people with Psilocybin and Neuropathy, run by M.D. Anderson Cancer Center at 1 site 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 0 inclusion and 65 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 Moran Amit, MD (713-794-5304, mamit@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). 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 3 Nov 2026.