Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (69 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 2013-12-31, after 2011-12-31 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 2013-12-31. 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: patientstreatment ofcontraceptiondiabetesto determine
Phrases that lowered it: individualsglaucomadisorderdependenceopen -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1/2 (raises risk) · Design
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Sponsor's past termination rate: 10.7% (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 27.6% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 37 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 0.9% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 112 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 60 (lowers risk) · Who can join
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Number of arms: 1 (raises 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
- 1/2 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (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
- 60 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 112 (typical: 32)
- Sponsor's past termination rate
- 10.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 37 (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
- 3212 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 367 (typical: 412.5)
- Drug's FAERS reports marked serious
- 27.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- lisdexamfetamine, lisdexamfetamine dimesylate
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
- Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence NCT01490216 · started 2011 · scored riskier than 12% of active trials terminated
- Treatment of Cocaine Dependence With Lisdexamfetamine NCT00958282 · started 2009 · scored riskier than 13% of active trials completed
- Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence NCT02034201 · started 2014 · scored riskier than 20% of active trials completed
- Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder NCT02537873 · started 2015 · scored riskier than 27% of active trials completed
- A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence NCT01651364 · started 2011 · scored riskier than 24% 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.