True · Brier 0.09
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 15 Mar 2021 · doblin-0132
Quote
“The Bronx VA study is only waiting on Drug Enforcement Administration (DEA) registration, which we expect in the coming months”
Winter 2021 column. MDMA/PTSD study at the Bronx VA (PI Rachel Yehuda) awaits DEA registration; Doblin expects it within months.
Intake
- EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
- DEA grants the Schedule I registration for the Bronx VA MDMA-assisted therapy PTSD study
- AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
- Regulatory decisions
- DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
- None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 15 Mar 2023
- Probability
- 0.70 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › B · “which we expect in the coming months”
- Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
- None in the table
- Tags
- affiliated, retrospective
- Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
- admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0084 · deadline none · bin B
Registry entry
The DEA grants the Schedule I researcher registration that the MAPS-sponsored MDMA-assisted therapy for PTSD study at the Bronx VA needs to begin.
TRUE on the earliest of (a) the date the sponsor (MAPS or MAPS PBC), the Bronx VA or the study's investigators publicly state that the DEA registration for the Bronx VA MDMA-assisted therapy for PTSD study has been granted, (b) the date a sponsor or VA announcement reports that the study has begun dosing or enrolling participants at the Bronx VA (dosing MDMA requires the registration), or (c) the date ClinicalTrials.gov first lists the Bronx VA site for that study with status Recruiting. A statement that the registration is pending, an IRB approval or a protocol approval is not the DEA registration. Resolution source: MAPS announcements and the ClinicalTrials.gov site status for that study. FALSE at the deadline when none of these has appeared.
Resolution source: MAPS announcements (press releases, MAPS Bulletin) and ClinicalTrials.gov site status for the Bronx VA MDMA/PTSD study
Readings: 'The Bronx VA study' = the MDMA-assisted therapy for PTSD study at the Veterans Affairs medical center in the Bronx, New York, with Rachel Yehuda as principal investigator, as named in the column.; 'DEA registration' = the Schedule I researcher registration for the site; the study starting at the site is accepted as evidence that the registration was granted.
How to read
Coder A
Resolution
- State
- True
- Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
- 15 Mar 2023
- Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
- occurred on 17 Nov 2021 · checked through 14 Sep 2026
- Resolver note
- Criterion (c) fixes the date. The MAPS-sponsored study at the James J. Peters VA Medical Center in the Bronx (NCT04784143, PI Rachel Yehuda) was first posted with the Bronx VA site and the study at status Recruiting in record version 5, submitted 2021-11-16 and posted publicly 2021-11-17; that same version gives an actual study start of 2021-11-08. Dosing MDMA at the site requires the DEA Schedule I registration, so the start is accepted as evidence that it was granted. The study later enrolled 26 participants. Earlier MAPS pages (2021-02-25, 2021-09-22) still describe the registration as pending. No separate DEA grant announcement was found, so the posted Recruiting status is the first verifiable date.
- Evidence
- Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD (NCT04784143), sole site James J. Peters VA Medical Center, The Bronx, NY; actual start 2021-11-08 · 17 Nov 2021
- NCT04784143 record history: version 5, submitted 2021-11-16 and posted 2021-11-17, is the first version with overall status and Bronx VA site status Recruiting · 17 Nov 2021
- Phase 2 Study at the Bronx, New York Veterans Affairs Medical Center · 25 Feb 2021
- Site Initiation Visit Takes Place for Phase 2 Study at the Veterans Affairs Medical Center in Bronx, New York · 22 Sep 2021
Adversarial recheck
upheld (date): Case for an earlier date: the same record gives an actual study start of 2021-11-08, eight days earlier, and dosing MDMA needs the registration, so the grant is earlier still; the MAPS site-initiation post of 2021-09-22 could also be read as the study beginning. The record history refuses both. Version 4, submitted 2021-11-09 and posted 2021-11-10, still shows overall status NOT_YET_RECRUITING, no site listed, and an estimated start of 2021-12-18. Version 5, submitted 2021-11-16 and posted 2021-11-17, is the first to show status RECRUITING, the James J. Peters VA Medical Center site RECRUITING, and the actual start of 2021-11-08. Criteria (b) and (c) both key on the date of the announcement or listing, not on the event reported, so 2021-11-17 is the first verifiable date. No MAPS statement announces the grant; the Winter 2021 bulletin (15 March 2021) still calls it pending.
How to read
Registry
Timeline
1 claim against 60 events in the field.
Regulatory decisions