A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
Model scores of the 29,894 trials active now.
Model score 10% 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 11% of the time (407 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 2010-05-31, after 2009-12-31 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 2010-05-31. 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: limitwomeniveffectdefined
Phrases that lowered it: participantssubjectsindividualsmaletrial -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Minimum age: 21 (lowers risk) · Who can join
-
Sponsor's past termination rate: 10% (raises risk) · Sponsor's track record
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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 type: academic or other (raises risk) · Sponsor's track record
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Blinding: triple (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 10.5% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 10 (lowers risk) · Sponsor's track record
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 10 (typical: 32)
- Sponsor's past termination rate
- 10% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (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
- 5086 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1092 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- baclofen, cyproheptadine
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
- Efficacy and Safety of High Dose Baclofen for Alcohol Dependence NCT01980706 · started 2013 · scored riskier than 14% of active trials completed
- Baclofen for Treating Anxiety and Alcoholism NCT01751386 · started 2012 · scored riskier than 6% of active trials completed
- An Open Label Trial of Bupropion and Naltrexone for Binge Drinking NCT02842073 · started 2016 · scored riskier than 11% of active trials completed
- Baclofen for the Treatment of Alcohol Dependence NCT01266655 · started 2011 · scored riskier than 11% of active trials completed
- Role of BP1.3656 on Alcohol Responses NCT04727086 · started 2021 · scored riskier than 7% 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.