Effect of Nicotine on Brain Reward Pathways
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 5% 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 (145 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-11-30, after 2015-02-28 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 2017-11-30. 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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Design: crossover (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: determinesubjects withivpatientsacute
Phrases that lowered it: healthyage between20caffeinebetween 18 -
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 31.4% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: 3.0% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Blinding: double (raises risk) · Design
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Primary purpose: basic science (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 38 (typical: 32)
- Sponsor's past termination rate
- 10.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 10 (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
- 23913 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1559 (typical: 412.5)
- Drug's FAERS reports marked serious
- 31.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.0% (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
- The Effects of Dopamine on Reward Processing NCT01253421 · started 2012 · scored riskier than 18% of active trials completed
- Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes NCT00960778 · started 2009 · scored riskier than 15% of active trials completed
- Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder NCT02067793 · started 2014 · scored riskier than 10% of active trials completed
- Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence NCT01874951 · started 2013 · scored riskier than 46% of active trials completed
- Depressed Mood Improvement Through Nicotine Dosing-3 (Depressed MIND3) Extension NCT05746546 · started 2023 · scored riskier than 28% 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.