A named product, route, population and condition.
Approval belongs to the exact product and use in the FDA label. It does not spread to a related ingredient, route or condition.
Psychedelics · California · ledger updated August 31, 2026
California psychedelic evidence ledger.
A result is not approval. A record is not access.
Compare exact products, study questions, reported results and what remains unknown. This page does not decide whether a business is legal or whether a treatment is right for you.
Prepared by the TherapyCalifornia evidence desk; every source below shows its own check date. Independent California clinical and licensed-prescriber review are pending. This preview is not in search-engine indexes and claims no review badge. Ledger updated August 31, 2026; next full source review: November 27, 2026.
Explore 25 records ↓The snapshot
One ledger. Four facts kept apart.
- Records
- 25
- Exact products or formulations
- 20
- Primary or official sources
- 28
- Record types
- 6
Four lanes that should not blur
Name the product, use and evidence record.
An approved product used in a way FDA did not approve.
Psychiatric use of FDA-approved ketamine injection is off-label. The approved anesthetic label does not become a psychiatric approval.
Compounding does not inherit approval.
A compounded ketamine product is not FDA-approved. It belongs in a different lane from off-label use of an approved injection.
A protocol asks a question. A result answers only that question.
A registered study is not FDA approval. Phase, an IND and a positive publication are not approval actions.
The reading rules
The shortest claims carry the largest errors.
- The study team decides eligibility.
- Registry status can change.
- A trial exclusion is not the same as an FDA-label contraindication.
- No posted result does not mean the study failed.
- An observational record does not establish treatment access.
- Results do not transfer automatically across products, routes, conditions or populations.
Use the ledger
Narrow the records without turning a filter into advice.
These three controls only hide or show records already on this page. They do not screen you, rank treatments or change the evidence.
Filter the evidence records
25 records shown
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FDA labelFDA-approved productRegulatory record—not a trial result
Record 01Spravato (esketamine nasal spray)
Treatment-resistant depression
The finding
The FDA label approves this exact nasal-spray product for adults with treatment-resistant depression, either alone or with an oral antidepressant. Treatment occurs in a certified health-care setting under direct observation.
FDA use statusFDA-approved specific use
Study stageCurrent FDA label
California study statusNot a study
Population studiedAdults with treatment-resistant depression
Intervention or productSpravato nasal spray as monotherapy or with an oral antidepressant
DesignFDA prescribing information; not one clinical trial
ComparisonNot applicable
SampleNot a trial
OutcomeApproved indication, administration and monitoring requirements
Outcome time pointCurrent label revised in 2025
Effect estimate or regulatory findingNot applicable
Follow-upThe label requires at least two hours of observation after each treatment.
Where the evidence stops
A product label is not a comparison with every other depression treatment. Its approval does not extend to ketamine injection or a compounded ketamine product.
Do not carry the result farther
It does not establish that every person with depression should receive Spravato, that an insurance plan will cover it, or that another ketamine product shares this approval.
What changes here—and what does not
This approved route is available only through the medical and REMS system that applies in California; it is not a general psychedelic-service licence.
FDA labelFDA-approved productRegulatory record—not a trial result
Record 02Spravato (esketamine nasal spray)
Major depression with acute suicidal ideation or behavior
The finding
The FDA label approves Spravato with an oral antidepressant for depressive symptoms in adults with major depression and acute suicidal ideation or behavior.
FDA use statusFDA-approved specific use
Study stageCurrent FDA label
California study statusNot a study
Population studiedAdults with major depressive disorder and acute suicidal ideation or behavior
Intervention or productSpravato nasal spray with an oral antidepressant
DesignFDA prescribing information; not one clinical trial
ComparisonNot applicable
SampleNot a trial
OutcomeApproved indication and limitation of use
Outcome time pointCurrent label revised in 2025
Effect estimate or regulatory findingNot applicable
Follow-upThe label requires at least two hours of observation after each treatment.
Where the evidence stops
The label says effectiveness in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated. Use does not rule out hospitalization when clinically warranted.
Do not carry the result farther
It does not make Spravato a substitute for emergency assessment, suicide-safety planning or a higher level of care.
What changes here—and what does not
A California crisis or emergency decision still belongs to emergency and licensed medical care; this indication is not a crisis referral tool.
FDA labelFDA-approved productRegulatory record—not a trial result
Record 03FDA-approved ketamine injection
Psychiatric-use boundary
The finding
The current label approves ketamine injection as a general anesthetic for named diagnostic and surgical uses. It lists intravenous and intramuscular routes.
FDA use statusNo FDA-approved psychiatric use
Study stageCurrent FDA label
California study statusNot a study
Population studiedPeople receiving anesthesia for labeled diagnostic or surgical uses
Intervention or productKetamine hydrochloride injection for intravenous or intramuscular use
DesignFDA prescribing information; not a psychiatric efficacy trial
ComparisonNot applicable
SampleNot a trial
OutcomeApproved indication and route
Outcome time pointLabel revised October 2025
Effect estimate or regulatory findingNot applicable
Follow-upNot a psychiatric follow-up record
Where the evidence stops
The label supplies no FDA-approved psychiatric indication and no psychiatric effect estimate.
Do not carry the result farther
It does not establish FDA approval for depression, PTSD, anxiety, OCD, pain or a compounded oral or nasal ketamine product.
What changes here—and what does not
Psychiatric use of FDA-approved ketamine injection is off-label. The exact injection, route, prescriber and monitoring still matter.
FDA safety communicationProduct not FDA-approvedRegulatory record—not a trial result
Record 04Compounded ketamine product
Psychiatric-use boundary
The finding
FDA states that compounded ketamine products are not FDA-approved and are not reviewed for safety, effectiveness or quality before marketing. Its alert names sedation, dissociation, blood-pressure changes, slowed breathing, misuse, urinary symptoms and the risks of use without onsite monitoring.
FDA use statusProduct not FDA-approved
Study stageFDA safety and compounding communication
California study statusNot a study
Population studiedPeople offered compounded ketamine for psychiatric disorders, including at-home use
Intervention or productCompounded ketamine, including oral or nasal formulations offered for psychiatric use
DesignRegulatory and safety communication; not a comparative trial
ComparisonNot applicable
SampleNot a trial
OutcomeProduct-review boundary and risks needing clinical monitoring
Outcome time pointFDA alert issued October 10, 2023; compounding page checked August 29, 2026
Effect estimate or regulatory findingNot applicable
Follow-upThe communication does not estimate long-term benefit or harm.
Where the evidence stops
This communication does not estimate how often each event occurs and is not a treatment-effect trial.
Do not carry the result farther
It does not mean every compounded prescription is unlawful or that coverage, a pharmacy label or a clinician's licence turns the compounded product into an FDA-approved product.
What changes here—and what does not
A California offer for compounded ketamine belongs in the product-not-approved lane, not the off-label lane for an FDA-approved injection.
Randomized trialFDA-approved productPublished primary result
Record 05Intravenous ketamine
Nonpsychotic treatment-resistant depression
The finding
The trial reported that ketamine was noninferior to ECT on its primary response outcome for this nonpsychotic population. Dissociation was associated with ketamine; musculoskeletal effects were associated with ECT.
FDA use statusOff-label psychiatric use of an approved product
Study stageRandomized noninferiority trial
California study statusNo California site in source
Population studiedAdults referred to ECT clinics for treatment-resistant major depression without psychosis
Intervention or productKetamine 0.5 mg/kg by 40-minute intravenous infusion twice weekly for three weeks
DesignOpen-label randomized comparison
ComparisonElectroconvulsive therapy three times weekly for three weeks
Sample403 randomized; 365 began assigned treatment · N = 403
OutcomeAt least 50% reduction on the 16-item self-reported depression scale
Outcome time pointEnd of the three-week treatment phase
Effect estimate or regulatory findingResponse: 55.4% with ketamine and 41.2% with ECT; difference 14.2 percentage points (95% CI, 3.9 to 24.2); ketamine met the prespecified noninferiority test.
Follow-upResponders were followed for six months.
ClinicalTrials.gov recordNCT03113968 official record ↗
Where the evidence stops
Treatment was open label, 38 people withdrew before starting, the trial excluded psychotic depression, and a noninferiority result does not make the treatments interchangeable.
Do not carry the result farther
It does not establish FDA approval for psychiatric ketamine, equivalence for compounded products, or superiority to ECT for every outcome or patient.
What changes here—and what does not
The comparison can inform a California prescriber discussion, but psychiatric use of the approved injection remains off-label and this study listed no California site.
Randomized trialProduct not FDA-approvedPublished primary result
Record 06Synthetic psilocybin
Major depressive disorder
The finding
The study reported larger reductions in depression scores with psilocybin than with niacin at both named time points.
FDA use statusInvestigational use
Study stagePhase 2 randomized trial
California study statusCalifornia site included in source
Population studiedAdults ages 21 to 65 with moderate or greater major depression
Intervention or productOne 25 mg dose of synthetic psilocybin with psychological support
DesignRandomized blinded trial
ComparisonNiacin 100 mg with the same psychological support
Sample104 randomized · N = 104
OutcomeChange in MADRS depression score
Outcome time pointDay 43 primary outcome; day 8 key secondary outcome
Effect estimate or regulatory findingBetween-group MADRS difference -12.3 points at day 43 (95% CI, -17.5 to -7.2) and -12.0 at day 8 (95% CI, -16.6 to -7.4).
Follow-up43 days after dosing
ClinicalTrials.gov recordNCT03866174 official record ↗
Where the evidence stops
It excluded people with a history of psychosis or mania and active suicidal intent, combined drug and support, required medication tapering for some people, and recognizable effects may have weakened masking.
Do not carry the result farther
It does not establish FDA approval, long-term benefit beyond the follow-up, the same result in excluded groups, or equivalence to mushrooms or another formulation.
What changes here—and what does not
California institutions participated in the research. That makes the source locally relevant, not a California treatment-access system.
Randomized trialProduct not FDA-approvedPublished primary result
Record 07COMP360 synthetic psilocybin
Treatment-resistant depression
The finding
The study reported a larger week-3 depression-score reduction for 25 mg than for the 1 mg control. It did not establish sustained response through week 12.
FDA use statusInvestigational use
Study stagePhase 2 randomized trial
California study statusCalifornia site included in source
Population studiedAdults with a treatment-resistant episode of major depression
Intervention or productOne 25 mg or 10 mg dose of COMP360 with psychological support
DesignDouble-blind randomized dose comparison
ComparisonA 1 mg psilocybin control, with psychological support in every group
Sample233 randomized · N = 233
OutcomeChange in MADRS depression score
Outcome time pointWeek 3 primary outcome; sustained response assessed through week 12
Effect estimate or regulatory findingWeek-3 change was -12.0 with 25 mg, -7.9 with 10 mg and -5.4 with 1 mg. The 25 mg versus 1 mg difference was -6.6 points (95% CI, -10.2 to -2.9); the 10 mg comparison was not significant.
Follow-up12 weeks
ClinicalTrials.gov recordNCT03775200 official record ↗
Where the evidence stops
Recognizable acute effects may have weakened masking. Adverse events were common, and suicidal ideation, suicidal behavior or self-injury occurred across dose groups.
Do not carry the result farther
It does not establish approval, durable benefit, superiority to established treatment or the same result for another psilocybin product or population.
What changes here—and what does not
California research sites were involved. This published trial does not establish California treatment access.
Randomized trialProduct not FDA-approvedPublished primary result
Record 08Synthetic psilocybin
Treatment-resistant depression
The finding
The prespecified 25 mg comparison on the primary response outcome was not statistically significant. Secondary depression-score changes were exploratory and favored 25 mg. Two serious adverse reactions followed 25 mg, including one case of hallucinogen persisting perception disorder; dosing-day suicidal ideation was reported more often with 25 mg than in comparator conditions.
FDA use statusInvestigational use
Study stagePhase 2b randomized trial
California study statusNo California site in source
Population studiedAdults ages 25 to 65 with treatment-resistant depression who withdrew from antidepressant medication, recruited mainly from two German outpatient settings
Intervention or productOne 25 mg oral dose of synthetic psilocybin with psychotherapeutic sessions before the week-6 primary outcome
DesignTwo-center triple-blinded active-placebo-controlled randomized trial
ComparisonNicotinamide 100 mg active placebo; a separate 5 mg psilocybin group was also studied
Sample144 randomized; 142 included in the primary efficacy analysis · N = 144
OutcomeAt least a 50% reduction on the 17-item Hamilton Rating Scale for Depression
Outcome time pointWeek 6, before the second study dose
Effect estimate or regulatory findingResponse was 17.0% with 25 mg, 12.5% with 5 mg and 10.6% with nicotinamide. The prespecified 25 mg comparison was not statistically significant: adjusted odds ratio 1.73 (95% CI, 0.53 to 6.23; P=.19).
Follow-upThe primary comparison was six weeks after the first dose; the trial continued with a second dose after that assessment.
ClinicalTrials.gov recordNCT04670081 official record ↗
Where the evidence stops
The trial was conducted at two German centers, participants stopped antidepressants, recognizable effects can weaken masking, and the formal testing sequence stopped after the first nonsignificant comparison.
Do not carry the result farther
Exploratory secondary signals do not replace the nonsignificant primary result. The study does not establish FDA approval, ordinary California access, benefit without its psychotherapy context, or safety for excluded groups.
What changes here—and what does not
This study had no California site. It belongs beside positive psilocybin trials so a California evidence discussion does not select only favorable results.
Randomized trialProduct not FDA-approvedPublished primary result
Record 09Synthetic psilocybin
Alcohol use disorder
The finding
The study reported fewer heavy-drinking days in the psilocybin group during the named period.
FDA use statusInvestigational use
Study stageRandomized clinical trial
California study statusNo California site in source
Population studiedAdults ages 25 to 65 with alcohol dependence and recent heavy-drinking days
Intervention or productTwo high-dose psilocybin sessions during a 12-week psychotherapy course
DesignDouble-blind randomized trial at two U.S. academic centers
ComparisonDiphenhydramine during the same psychotherapy course
Sample95 randomized; 93 received study medication and entered the primary analysis · N = 95
OutcomePercentage of heavy-drinking days
Outcome time point32 weeks after the first medication session
Effect estimate or regulatory findingHeavy-drinking days were 9.7% with psilocybin and 23.6% with diphenhydramine; mean difference 13.9 percentage points (95% CI, 3.0 to 24.7).
Follow-up32-week double-blind period
ClinicalTrials.gov recordNCT02061293 official record ↗
Where the evidence stops
The study was small, used two academic centers, combined drug and psychotherapy, and excluded several psychiatric, medical and substance-use groups.
Do not carry the result farther
It does not establish FDA approval, benefit without the study psychotherapy, safety for excluded groups or a California access route.
What changes here—and what does not
This study had no California site. It can inform the evidence discussion but not a claim about California availability.
Randomized trialProduct not FDA-approvedPublished primary result
Record 10Midomafetamine (MDMA) with manualized therapy
Severe PTSD
The finding
The study reported a larger reduction in PTSD symptoms with MDMA plus therapy than with placebo plus the same therapy package.
FDA use statusInvestigational use
Study stagePhase 3 randomized trial
California study statusNot a California access record
Population studiedAdults with severe PTSD, including common comorbidities allowed by the protocol
Intervention or productThree MDMA medication sessions with preparation and integration therapy
DesignRandomized double-blind placebo-controlled trial
ComparisonPlacebo with the same manualized therapy sequence
Sample90 randomized · N = 90
OutcomeChange in CAPS-5 PTSD score
Outcome time pointTwo months after the last experimental session
Effect estimate or regulatory findingMean CAPS-5 change among completers was -24.4 with MDMA and -13.9 with placebo; reported between-group effect size d=0.91.
Follow-upPrimary assessment two months after the last experimental session
ClinicalTrials.gov recordNCT03537014 official record ↗
Where the evidence stops
The drug's recognizable effects threaten masking, and the design does not isolate the contribution of the drug from the full therapy package.
Do not carry the result farther
It does not establish FDA approval, a California service route, long-term benefit or that the same result occurs outside the protocol.
What changes here—and what does not
This publication is evidence to read, not approval or a referral. The later FDA review record belongs beside it.
Randomized trialProduct not FDA-approvedPublished primary result
Record 11Midomafetamine (MDMA) with manualized therapy
Moderate-to-severe PTSD
The finding
The study reported larger PTSD and disability-score reductions in the MDMA group. Seven severe treatment-emergent adverse events occurred; the paper reported no deaths or serious treatment-emergent adverse events.
FDA use statusInvestigational use
Study stageConfirmatory phase 3 randomized trial
California study statusNot a California access record
Population studiedAdults with moderate-to-severe PTSD
Intervention or productMDMA-assisted therapy through the study treatment sequence
DesignRandomized double-blind placebo-controlled trial
ComparisonPlacebo with identical manualized therapy
Sample104 randomized · N = 104
OutcomeChange in CAPS-5 PTSD score and Sheehan Disability Scale
Outcome time pointWeek 18 FDA analysis of the treatment sequence
Effect estimate or regulatory findingCAPS-5 change was -23.7 with MDMA-assisted therapy and -14.8 with placebo plus therapy (effect size d=0.7). Disability change was -3.3 versus -2.1 (d=0.4).
Follow-upThe controlled treatment sequence ended at week 18; durability data had additional limitations in FDA review.
ClinicalTrials.gov recordNCT04077437 official record ↗
Where the evidence stops
Functional unblinding and expectation bias remain important. The therapy contribution cannot be separated cleanly, and the FDA review identified data-quality and safety-monitoring questions.
Do not carry the result farther
It does not establish FDA approval, a favorable final benefit-risk decision, California access or the same result in ordinary practice.
What changes here—and what does not
A positive publication is not an approved California service. FDA's public review record must remain part of the evidence chain.
FDA regulatory reviewProduct not FDA-approvedFDA advisory review—not final approval
Record 12Midomafetamine (MDMA) capsules, NDA 215455
Proposed PTSD indication
The finding
The committee discussed functional unblinding, expectation bias, the therapy contribution, durability, boundary violations, missing safety measurements, cardiac data, abuse liability, diversion and monitoring. Most members voted no on both questions.
FDA use statusInvestigational use
Study stageFDA advisory committee review
California study statusNot a study
Population studiedThe proposed adult PTSD population in the application
Intervention or productProposed midomafetamine treatment with psychological intervention
DesignPublic review of a new drug application; not a separate trial
ComparisonThe committee considered the full submitted benefit-risk record
SampleNot a separate trial
OutcomeCommittee questions on evidence of effectiveness and benefit versus risk
Outcome time pointMeeting June 4, 2024; final minutes approved July 26, 2024
Effect estimate or regulatory findingEffectiveness vote: 2 yes, 9 no. Benefit-risk vote: 1 yes, 10 no. Advisory votes are nonbinding.
Follow-upNot applicable
Where the evidence stops
An advisory committee gives nonbinding advice. The minutes are not a final approval action and do not replace the full FDA review.
Do not carry the result farther
It does not erase the trial findings, prove the intervention never helps, or create an approved product or service.
What changes here—and what does not
California marketing should not present the phase 3 papers alone as settled proof of approval, safety or availability.
Randomized trialProduct not FDA-approvedPublished primary result
Record 13MM120 (lysergide D-tartrate; LSD)
Generalized anxiety disorder
The finding
The study reported a dose-response signal at 100 and 200 micrograms. Visual perceptual changes, nausea and headache increased with dose.
FDA use statusInvestigational use
Study stagePhase 2b randomized trial
California study statusCalifornia site included in source
Population studiedAdults with moderate-to-severe generalized anxiety disorder
Intervention or productOne freebase-equivalent dose of 25, 50, 100 or 200 micrograms MM120
DesignMulticenter randomized double-blind placebo-controlled dose-response trial
ComparisonPlacebo
Sample198 randomized; 194 in the full analysis set · N = 198
OutcomeChange in HAM-A anxiety score
Outcome time pointWeek 4 primary outcome
Effect estimate or regulatory findingCompared with placebo, HAM-A difference was -5.0 points with 100 freebase-equivalent micrograms (95% CI, -9.6 to -0.4) and -6.0 with 200 freebase-equivalent micrograms (95% CI, -9.8 to -2.0). The two lower doses were not significant.
Follow-up12 weeks
ClinicalTrials.gov recordNCT05407064 official record ↗
Where the evidence stops
Recognizable acute effects create masking risk, follow-up was 12 weeks, and the sponsor was involved in the study and publication.
Do not carry the result farther
It does not establish approval, long-term benefit, a California treatment route or equivalence to another LSD formulation or setting.
What changes here—and what does not
California sites participated in this phase 2b trial. That does not establish an approved California treatment route.
Randomized trialProduct not FDA-approvedPublished primary result
Record 14SPL026 (intravenous DMT fumarate)
Moderate-to-severe major depressive disorder
The finding
The study reported a larger two-week depression-score reduction with DMT. It reported no serious adverse events in this small trial.
FDA use statusInvestigational use
Study stagePhase 2a randomized trial
California study statusNo California site in source
Population studiedAdults with moderate-to-severe major depression
Intervention or productOne 21.5 mg DMT infusion over 10 minutes with supportive psychotherapeutic support
DesignDouble-blind randomized placebo-controlled phase followed by an open-label phase
ComparisonPlacebo during the two-week controlled phase
Sample34 randomized · N = 34
OutcomeChange in MADRS depression score
Outcome time pointTwo weeks after the controlled infusion
Effect estimate or regulatory findingDMT-placebo MADRS difference -7.35 points (95% CI, -13.62 to -1.08).
Follow-upControlled comparison for two weeks; open-label follow-up to three months
ClinicalTrials.gov recordNCT04673383 official record ↗
Where the evidence stops
Only 34 people entered the randomized comparison. The later follow-up was open label, so it cannot establish comparative durability.
Do not carry the result farther
It does not establish approval, uncommon or delayed safety, the same result for smoked or other DMT products, or a California treatment route.
What changes here—and what does not
There were no California sites. This result does not turn California DMT mechanism or observational records into treatment access.
Randomized trialProduct not FDA-approvedPublished primary result
Record 15GH001 inhaled mebufotenin (5-MeO-DMT)
Treatment-resistant depression
The finding
The study reported a larger day-8 depression-score reduction with GH001 and no severe or serious adverse events during the controlled period.
FDA use statusInvestigational use
Study stagePhase 2b randomized trial
California study statusNo California site in source
Population studiedAdults with treatment-resistant depression in a European trial
Intervention or productAn individualized single-day regimen of up to three escalating inhaled doses
DesignSeven-day randomized double-blind placebo-controlled phase with an open-label extension
ComparisonPlacebo individualized dosing regimen
Sample81 randomized · N = 81
OutcomeChange in MADRS depression score
Outcome time pointDay 8
Effect estimate or regulatory findingMADRS difference -15.5 points (SE 1.7); day-8 remission 23 of 40 with GH001 and 0 of 41 with placebo.
Follow-upSeven-day controlled comparison; six-month extension was open label
ClinicalTrials.gov recordNCT05800860 official record ↗
Where the evidence stops
The controlled comparison lasted seven days, the trial was conducted in Europe, and the longer extension lacked a blinded comparator.
Do not carry the result farther
It does not establish long-term comparative benefit, rare harms, approval, California-specific outcomes or a California treatment route.
What changes here—and what does not
This Europe-only result is not a California access record. California registry searches should remain separate.
Observational studyProduct not FDA-approvedPublished primary result
Record 16Magnesium-ibogaine protocol
Traumatic brain injury with functional or psychiatric symptoms
The finding
The study reported large pre-post changes and no unexpected or serious adverse events in this selected sample.
FDA use statusInvestigational use
Study stageProspective observational study
California study statusCalifornia-led source—not an access route
Population studied30 male Special Operations Forces veterans with predominantly mild traumatic brain injury
Intervention or productIbogaine with magnesium and complementary treatment modalities
DesignPre-post observational study without a randomized or concurrent comparison group
ComparisonParticipants compared with their own baseline
Sample30 participants · N = 30
OutcomeDisability immediately and at one month; PTSD, depression and anxiety at one month
Outcome time pointImmediately and one month after treatment
Effect estimate or regulatory findingReported effect sizes: disability d=0.74 immediately and 2.20 at one month; PTSD d=2.54, depression d=2.80 and anxiety d=2.13 at one month.
Follow-upOne month
ClinicalTrials.gov recordNCT04313712 official record ↗
Where the evidence stops
There was no control group, all participants were selected male veterans, and ibogaine was delivered with magnesium and other modalities. Authors and partners disclosed patents and commercial interests.
Do not carry the result farther
It cannot attribute the changes to ibogaine alone, rule out expectancy or natural change, establish rare cardiac safety or generalize to a broader population.
What changes here—and what does not
The research was Stanford-led, but treatment occurred outside an ordinary California care route. An observational record does not establish treatment access.
Observational studyProduct not FDA-approvedPublished safety signal
Record 17Ibogaine hydrochloride
Opioid use disorder
The finding
The study reported clinically important QTc prolongation, bradycardia and severe transient ataxia. Every participant developed severe ataxia; no torsades de pointes occurred in this small sample.
FDA use statusInvestigational use
Study stageOpen-label safety study
California study statusNo California site in source
Population studied14 people with opioid use disorder receiving opioid-maintenance treatment
Intervention or productOne 10 mg/kg dose with at least 24 hours of medical monitoring
DesignDescriptive uncontrolled study
ComparisonNo comparison group
Sample14 participants · N = 14
OutcomeQTc, blood pressure, heart rate, ataxia and delirium
Outcome time pointAt least 24 hours after dosing
Effect estimate or regulatory findingMean maximum QTc prolongation 95 ms (range 29 to 146); 7 of 14 exceeded 500 ms; 6 of 14 remained above 450 ms beyond 24 hours.
Follow-upAt least 24 hours
Where the evidence stops
The study was small, uncontrolled and conducted under medical monitoring. Absence of torsades in 14 people cannot establish absence of risk.
Do not carry the result farther
It does not establish treatment benefit, safety in an unmonitored setting or the adequacy of a shorter monitoring period.
What changes here—and what does not
Any California ibogaine claim should place this cardiac and ataxia signal beside positive observational findings.
Randomized trialProduct not FDA-approvedPublished primary result
Record 18TSND-201 (methylone)
PTSD
The finding
The study reported greater PTSD-score improvement with TSND-201 and secondary changes that favored TSND-201. Common events included headache, appetite loss, nausea, dizziness, increased blood pressure, dry mouth and insomnia.
FDA use statusInvestigational use
Study stagePhase 2 randomized trial
California study statusNot a California access record
Population studiedAdults with PTSD
Intervention or productFour weekly oral dosing sessions without psychotherapy, with nondirective professional monitoring
DesignMulticenter double-blind placebo-controlled trial
ComparisonPlacebo
Sample65 participants · N = 65
OutcomeChange in CAPS-5 PTSD score
Outcome time pointDay 64, six weeks after the final dose
Effect estimate or regulatory findingThe abstract reports a significant between-group CAPS-5 difference (P=.01), but its printed point estimate and confidence-interval signs are internally inconsistent; this ledger does not reproduce that estimate as settled.
Follow-upSix weeks after the fourth dose
ClinicalTrials.gov recordNCT05741710 official record ↗
Where the evidence stops
This was a small sponsor-led phase 2 study using 90% confidence intervals. The abstract's sign inconsistency needs full-table verification before a precise estimate is reused.
Do not carry the result farther
It does not establish approval, durable benefit, a California treatment route or that methylone is interchangeable with MDMA.
What changes here—and what does not
This published study does not establish a California treatment route.
Randomized trialProduct not FDA-approvedPublished primary result
Record 19Ayahuasca botanical preparation
Treatment-resistant depression
The finding
The study reported lower depression scores with ayahuasca at the measured time points and a larger day-7 response proportion.
FDA use statusInvestigational use
Study stageRandomized clinical trial
California study statusNo California site in source
Population studiedAdults with treatment-resistant depression at one Brazilian center
Intervention or productOne dose of the study's ayahuasca preparation
DesignParallel-arm double-blind placebo-controlled trial
ComparisonPlacebo
Sample29 participants analyzed · N = 29
OutcomeMADRS and HAM-D depression scores
Outcome time pointDays 1, 2 and 7
Effect estimate or regulatory findingDay-7 response 64% with ayahuasca and 27% with placebo; remission 36% and 7%, respectively. The remission comparison did not meet the study's significance threshold.
Follow-upSeven days
ClinicalTrials.gov recordNCT02914769 official record ↗
Where the evidence stops
The study was very small, single center and only seven days long. The botanical preparation contains multiple constituents.
Do not carry the result farther
It does not establish long-term benefit, uncommon harms, approval, California availability or equivalence to DMT alone or another brew.
What changes here—and what does not
The study had no California participants and is not a California authorization or access record.
Randomized trialProduct not FDA-approvedPublished safety signal
Record 20Mescaline
Healthy-volunteer pharmacology
The finding
The study reported dose-dependent acute effects. Nausea and vomiting were frequent at 800 mg; ketanserin reduced and shortened acute effects.
FDA use statusInvestigational use
Study stageRandomized pharmacology study
California study statusNo California site in source
Population studied16 healthy adults
Intervention or productMescaline 100, 200, 400 or 800 mg; 800 mg was also tested with ketanserin
DesignDouble-blind placebo-controlled crossover study
ComparisonPlacebo and an 800 mg mescaline condition with ketanserin
Sample16 participants · N = 16
OutcomeSubjective effects, vital signs, adverse effects and pharmacokinetics
Outcome time pointUp to 30 hours
Effect estimate or regulatory findingAverage subjective-effect duration increased from 6.4 to 14 hours across 100 to 800 mg; blood pressure rose above 100 mg and heart rate rose with dose.
Follow-up30 hours
Where the evidence stops
This was a small healthy-volunteer study, not a mental-health treatment trial. It did not test peyote as a plant preparation.
Do not carry the result farther
It does not establish treatment benefit, long-term safety, approval or a California service route.
What changes here—and what does not
The source can support dose, duration and acute-physiology statements only—not a California mental-health treatment claim.
Randomized trialProduct not FDA-approvedPublished primary result
Record 21Psilocybin and MDMA trial blinding
Healthy-volunteer research methods
The finding
Participants could often identify the experienced condition. Methylphenidate masked MDMA more effectively than it masked psilocybin, and certainty ratings changed the apparent degree of unblinding.
FDA use statusInvestigational use
Study stageComparative randomized controlled study
California study statusNo California site in source
Population studied120 healthy volunteers
Intervention or productPsilocybin, MDMA or methylphenidate active placebo in a comparative randomized study
DesignDouble-blind randomized comparison with forced-choice guesses, certainty ratings and subjective-effect measures
ComparisonPsilocybin and MDMA were each compared with methylphenidate as an active placebo condition
Sample120 healthy volunteers · N = 120
OutcomeBlinding integrity and functional unblinding
Outcome time pointDuring the randomized study assessments reported in the primary publication
Effect estimate or regulatory findingThe abstract reports insufficient overall blinding: functional unblinding was highest for psilocybin, moderate for MDMA and lowest for methylphenidate. It does not provide the exact group percentages in the abstract.
Follow-upThis was a methods analysis of the study experience, not a treatment follow-up study.
Where the evidence stops
The study involved healthy volunteers and tested blinding, not treatment efficacy or clinical safety. The abstract does not provide every guess rate needed for a numerical reanalysis.
Do not carry the result farther
It does not show that any specific treatment result is entirely due to expectation, nor does it establish approval, effectiveness, safety or a California access route.
What changes here—and what does not
Use this record to read psychedelic trial effect estimates more carefully. It does not create or close a California treatment option.
Registered research protocolProduct not FDA-approvedProtocol only—no verified result
Record 22(2R,6R)-Hydroxynorketamine (RR-HNK)
Obsessive-compulsive disorder
The finding
ClinicalTrials.gov describes RR-HNK as a ketamine metabolite and asks whether either dose changes OCD symptoms versus saline. The Palo Alto Stanford site is listed as recruiting in the August 31, 2026 registry snapshot.
FDA use statusInvestigational use
Study stagePhase 1/2 recruiting pilot protocol
California study statusRegistry lists California recruiting
Population studiedAdults ages 18 to 65 with OCD who meet the protocol and have failed or declined at least one standard first-line treatment
Intervention or productOne intravenous infusion of 0.25 mg/kg or 0.5 mg/kg RR-HNK
DesignRandomized parallel triple-masked study
ComparisonSterile saline placebo
Sample45 planned · N = 45
OutcomeChange in Yale-Brown Obsessive Compulsive Scale score
Outcome time pointBaseline to week 1 after a single infusion
Effect estimate or regulatory findingNo result is available to summarize.
Follow-upThe registry lists study assessments beyond the week-1 primary outcome and an estimated completion in November 2029.
ClinicalTrials.gov recordNCT06575075 official record ↗
Where the evidence stops
This is a sponsor-posted protocol with planned enrollment, not a completed result. Overall status and the local site can change, and the registry record does not establish a treatment opening for any particular person.
Do not carry the result farther
No posted result does not mean the study failed. The protocol does not establish approval, effectiveness, eligibility, ordinary treatment access or that RR-HNK shares ketamine injection or Spravato approvals.
What changes here—and what does not
The registry lists one California research site in Palo Alto. The study team decides eligibility, and registry status can change.
Registered research protocolProduct not FDA-approvedProtocol only—no verified result
Record 23CYB003
Major depressive disorder
The finding
The sponsor-posted registry record describes CYB003 as a deuterated psilocin analog and lists a randomized Phase 3 question. It names California sites whose local status is recruiting or not yet recruiting.
FDA use statusInvestigational use
Study stagePhase 3 recruiting protocol
California study statusRegistry lists California recruiting
Population studiedAdults ages 18 to 85 with major depressive disorder under the protocol
Intervention or productTwo 8 mg CYB003 doses or two 16 mg CYB003 doses, about three weeks apart; all participants continue their current antidepressants and receive manualized psychological support.
DesignRandomized parallel quadruple-masked study
ComparisonTwo placebo sessions about three weeks apart, with the same continued antidepressant treatment and psychological support.
Sample330 planned · N = 330
OutcomeChange in MADRS depression score
Outcome time pointAssessments through day 84
Effect estimate or regulatory findingNo result is available to summarize.
Follow-upPlanned through day 84; completion estimated May 2027
ClinicalTrials.gov recordNCT06793397 official record ↗
Where the evidence stops
This is a protocol with planned enrollment, not a completed result. No posted registry result or linked peer-reviewed primary report was verified for this Phase 3 record as of the snapshot date.
Do not carry the result farther
No posted result does not mean the study failed. A Phase 3 record does not establish approval, effectiveness, eligibility or that a site will enroll a particular person.
What changes here—and what does not
The registry lists California research sites. The study team decides eligibility, and registry status can change.
Registered research protocolProduct not FDA-approvedProtocol only—no verified result
Record 24RE104
Adjustment disorder with cancer or another medical illness
The finding
The registry asks whether 30 mg differs from 1.5 mg at day 7. It lists recruiting California sites in San Diego and Santa Rosa.
FDA use statusInvestigational use
Study stagePhase 2 recruiting protocol
California study statusRegistry lists California recruiting
Population studiedAdults ages 18 to 80 meeting the protocol's adjustment-disorder and medical-illness criteria
Intervention or productOne subcutaneous 30 mg dose of RE104 for Injection
DesignRandomized triple-masked dose-controlled study
ComparisonA 1.5 mg active comparator dose
Sample100 planned · N = 100
OutcomeChange in MADRS depression score
Outcome time pointDay 7 primary outcome; safety follow-up through day 42
Effect estimate or regulatory findingNo result is available to summarize.
Follow-up42 days planned
ClinicalTrials.gov recordNCT07002034 official record ↗
Where the evidence stops
This is a sponsor-posted protocol. No posted registry result or linked peer-reviewed primary report was verified for this record as of the snapshot date.
Do not carry the result farther
No posted result does not mean the study failed. A recruiting record does not establish approval, effectiveness, eligibility or ordinary treatment access.
What changes here—and what does not
The registry lists California sites as recruiting. The study team decides eligibility, and registry status can change.
Registered research protocolProduct not FDA-approvedProtocol only—no verified result
Record 25RE104
Generalized anxiety disorder
The finding
The registry asks whether 30 mg differs from placebo at week 4. It lists recruiting California sites in Garden Grove, La Jolla, San Francisco and Santa Monica.
FDA use statusInvestigational use
Study stagePhase 2 recruiting protocol
California study statusRegistry lists California recruiting
Population studiedAdults ages 18 to 74 meeting the protocol's generalized-anxiety criteria
Intervention or productOne subcutaneous 30 mg dose of RE104 for Injection
DesignRandomized triple-masked placebo-controlled study
ComparisonSaline placebo injection
Sample64 planned · N = 64
OutcomeChange in HAM-A anxiety score
Outcome time pointWeek 4 primary outcome; planned follow-up through week 12
Effect estimate or regulatory findingNo result is available to summarize.
Follow-up12 weeks planned
ClinicalTrials.gov recordNCT07489651 official record ↗
Where the evidence stops
This is a sponsor-posted protocol. No posted registry result or linked peer-reviewed primary report was verified for this record as of the snapshot date.
Do not carry the result farther
No posted result does not mean the study failed. A recruiting record does not establish approval, effectiveness, eligibility or ordinary treatment access.
What changes here—and what does not
The registry lists California sites as recruiting. The study team decides eligibility, and registry status can change.
No records match this view.
This does not mean no research or care exists. Clear the filters to see the full ledger.
No matching California record appeared in this August 31, 2026 snapshot. That is not proof that no research exists.
Method and update clock
A source earns a sentence—not a halo.
Primary FDA records, ClinicalTrials.gov records and peer-reviewed primary studies were read for the exact product, population, comparison, outcome and time point shown. A positive result is not approval, a protocol is not a result, and no posted result does not mean a study failed.
- Schema version
- 1
- Source checks
- August 29, 2026–August 31, 2026
- Next full review
- November 27, 2026
- Review state
- Clinical and licensed-prescriber review pending
A source can support the exact population, product, comparison, outcome and time point shown. It cannot silently answer a different question.
Complete source trail
Every claim stays beside its source.
All 28 FDA, registry and peer-reviewed primary records are linked in the evidence cards above, with publisher and check date. A link supports a bounded statement; it is not an endorsement.
Source type, publication or revision date, registry number and DOI remain in the versioned ledger dataset. The page repeats no second source catalog because duplicate markup would make this evidence tool materially slower on a phone.
Educational information, not medical advice, legal advice, treatment ranking or research recruitment. The study team decides eligibility. Registry status can change. Clinical and licensed-prescriber review are pending. Paid for by participating therapists. Inclusion is computed, never purchased. No ads. No data sold.