The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2016-11-30, after 2008-01-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2016-11-30. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: evidencepaininjurytreatmentiv
Phrases that lowered it: smokingalcoholparticipantssmokersdrinking -
Design: factorial (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Phase: 2 (raises risk) · Design
-
Minimum age: 21 (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 85 (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 3.0% (lowers risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
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Sponsor's past termination rate: 7.2% (lowers risk) · Sponsor's track record
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Maximum age: 55 (lowers risk) · Who can join
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Sponsor's past trials: 69 (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports before start: 3590 (raises 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
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 69 (typical: 32)
- Sponsor's past termination rate
- 7.2% (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3590 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3274 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- naltrexone, varenicline
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
- Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder NCT02990455 · started 2017 · scored riskier than 4% of active trials completed
- Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment NCT00938886 · started 2009 · scored riskier than 13% of active trials completed
- Varenicline Treatment of Alcohol Dependence in Smokers NCT01553136 · started 2012 · scored riskier than 21% of active trials completed
- Varenicline for Smoking Cessation in Heavy Drinking Smokers NCT00860028 · started 2008 · scored riskier than 40% of active trials completed
- Combining Varenicline and Naltrexone for Smoking Cessation NCT02698215 · started 2016 · 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.