Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-17, after 2023-05-05 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-10-17. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Minimum age: 25 (lowers risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 3.2% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: coronaryarterydiseaseevidencestroke
Phrases that lowered it: healthyparticipantpharmacokineticto compareinteraction -
Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: single (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 31 (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 25 (typical: 18)
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 31 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dimethyltryptamine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder NCT03446846 · started 2018 · scored riskier than 41% of active trials completed
- IM and IV SPL026 Drug Product in Healthy Participants NCT05644093 · started 2023 · scored riskier than 2% of active trials completed
- A Study in Patients With Trichotillomania NCT03797521 · started 2018 · scored riskier than 41% of active trials completed
- A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) NCT06051721 · started 2024 · scored riskier than 13% of active trials completed
- Trichomylin® Safety, Tolerability & Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation NCT04867057 · started 2021 · scored riskier than 10% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.