| Protocol ID | NCT07332143 |
| Registration Date | 2026-01-12 |
| Status | not yet recruiting |
| Sponsor | Emory University |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2026-03-01 |
| Last Patient Out | 2027-03-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT07332143
The Safety and Acceptability of Psilocybin With Support and With Massed Prolonged Exposure Therapy for PTSD
| Field |
GLM
glm-5.1 8636ms / 9941 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5023ms / 11322 tok |
OPENAI
gpt-4o Thinking: o3 3300ms / 9778 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 | OK |
| setting_patient |
outpatient
outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
|
outpatient
outpatient → outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: outpatient — The study involves clinic visits for therapy sessions and psilocybin administration with participants going home between sessions, as evidenced by references to 'support sessions 1 week apart' and participants being 'accompanied to hotel after Medicine Session.'
|
outpatient
mixed → outpatient
shaky reasoning✓ Unanimous
Initial: mixed
Requery: outpatient — The interventions involve therapy sessions and psilocybin dosing without mention of hospitalization, indicating outpatient care.
|
OK |
| setting_place |
other
other
shaky reasoning✓ Unanimous
Initial: other
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The study involves multiple therapy sessions, preparatory sessions, dosing sessions, and follow-up visits that appear to be conducted in an outpatient clinical setting at Emory University rather than requiring patient hospitalization.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention involves psychotherapy sessions and online surveys, which indicates a community or outpatient setting rather than an inpatient hospital setting.
|
OK |
| feasibility |
feasibility RCT
feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
|
feasibility RCT
fully powered RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: feasibility RCT — This is explicitly described as a pilot study with primary objectives focused on investigating tolerability, safety, and acceptability rather than being designed as a fully powered efficacy trial.
|
feasibility RCT
feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — The trial is explicitly described as a pilot study with primary objectives including safety, tolerability, and acceptability.
|
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 | yes | yes | yes | OK |
| intervention_complex | yes | yes | yes | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | 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 | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary outcomes measure PTSD and depression symptoms, which fall under the symptom category.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary outcomes focus on PTSD and depression symptom severity measures, which fall under the symptom category.
Thinking: yes — Study includes acceptability assessments and fear extinction learning measures, which are feasibility and knowledge/skills outcomes beyond symptom/QoL categories.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study evaluates safety, tolerability, and acceptability, which are not covered by symptom/QoL/dignity/cost categories.
Thinking: yes — Trial measures safety, tolerability and acceptability, which are feasibility metrics outside symptom/QoL/dignity/cost.
|
OK |
| pharmacologic_sub | controlled substances | controlled substances | controlled substances | OK |