Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (146 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-01-10, after 2018-06-01 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 2023-01-10. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: unstablereducednursinglownew
Phrases that lowered it: cigarettesnicotinecomparemalenormal -
Minimum age: 21 (lowers risk) · Who can join
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Collaborators: 5 (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 26.3% (lowers risk) · Drug's FDA history
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 2.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 85 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 298 (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 41540 (lowers risk) · Drug's FDA history
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 5 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 298 (typical: 32)
- Sponsor's past termination rate
- 6.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 85 (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
- 41540 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4571 (typical: 412.5)
- Drug's FAERS reports marked serious
- 26.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- nicotine
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
- Innovative Interventions for Smoking Cessation NCT01050569 · started 2008 · scored riskier than 8% of active trials completed
- Very Low-Nicotine Cigarettes in Smokers With SUD NCT01989507 · started 2014 · scored riskier than 9% of active trials completed
- Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use NCT02870218 · started 2019 · scored riskier than 5% of active trials completed
- Facilitating Smoking Cessation With Reduced Nicotine Cigarettes NCT02796391 · started 2017 · scored riskier than 16% of active trials completed
- Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use NCT04084210 · started 2020 · 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.