| Protocol ID | NCT05883540 |
| Registration Date | 2023-06-01 |
| Status | recruiting |
| Sponsor | University Hospital, Basel, Switzerland |
| Country | Switzerland |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2024-06-09 |
| Last Patient Out | 2028-05-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 22 Years - |
NCT05883540
Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5162ms / 11513 tok |
OPENAI
gpt-4o Thinking: o3 6381ms / 9849 tok |
GLM
glm-5.1 12874ms / 10024 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec |
N/A
N/A → N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study includes patients with end-stage fatal disease of any cause, which encompasses both cancer and non-cancer conditions in a mixed population.
Thinking: N/A — Study includes any end-stage fatal disease which is a mixed population that could include both cancer and non-cancer patients.
|
N/A
N/A → early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: early palliative care — The study is focused on the effects of LSD in terminally ill patients with various end-stage diseases, aiming for early integration of palliative care to improve psychosocial well-being without specifying a single organ system.
Thinking: N/A — Population includes any end-stage fatal disease, likely mixing cancer and non-cancer patients, so no specific non-cancer category applies.
|
N/A
early palliative care → early palliative care
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: early palliative care — The study includes patients with any end-stage fatal disease without restricting to a specific organ system, focusing on psychosocial distress in a palliative care population with a life expectancy of 12 weeks to 2 years.
|
OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is an outpatient clinical trial where palliative care patients receive supervised drug interventions at the hospital/medical center for therapeutic sessions but are not hospitalized as inpatients.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The trial is conducted at University Hospital, Basel, but the intervention involves outpatient administration of LSD without hospitalization.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The study is a phase II trial conducted by University Hospital Basel with 3 sites, delivering LSD to patients with end-stage fatal diseases who are likely not hospitalized, indicating an outpatient palliative care setting.
|
OK |
| feasibility |
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — This is a Phase II randomized controlled trial with 60 participants designed to evaluate clinical effectiveness of LSD on psychosocial distress in palliative care patients, with primary outcome being state anxiety changes rather than feasibility metrics.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The trial has a sample size of 60 with clinical outcomes, indicating it is likely powered for clinical effectiveness.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The study is a Phase II randomized controlled trial with an enrollment of 60 patients designed to evaluate the clinical effectiveness of LSD on psychosocial distress using clinical scales like STAI-S as primary outcomes.
|
OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a pharmacologic study testing LSD (a drug intervention) in palliative care patients, not a study of palliative care service delivery itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study focuses on evaluating the effects of LSD on psychosocial distress in terminally ill patients, which falls under pharmacologic intervention rather than palliative care as the intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is a pharmacologic drug trial (LSD) conducted in a palliative care setting rather than testing palliative care itself as the intervention.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | yes | yes | yes | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
controlled substances
controlled substances → controlled substances → controlled substances
shaky reasoning✗ No consensus
Initial: controlled substances
Requery: controlled substances — LSD (lysergic acid diethylamide) is a Schedule I controlled substance with high potential for abuse and no accepted medical use in the United States.
Thinking: controlled substances — LSD is a Schedule I controlled substance being investigated for therapeutic use in palliative care patients.
|
controlled substances
controlled substances → not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning✗ No consensus
Initial: controlled substances
Requery: not yet FDA/EMA approved — LSD is being investigated for its effects in palliative care and is not approved by the FDA/EMA for this indication.
Thinking: not yet FDA/EMA approved — LSD is an investigational psychedelic drug with no FDA or EMA marketing approval for any indication.
|
not yet FDA/EMA approved
not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning✗ No consensus
Initial: not yet FDA/EMA approved
Requery: not yet FDA/EMA approved — LSD is an experimental and investigational drug that is not approved for therapeutic use by the FDA or EMA.
|
|