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Comparison · NCT03852628-deaths

2mg Buprenex and 380mg Vivitrol vs Placebo: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 2mg Buprenex and 380mg Vivitrol vs Placebo: deaths from any cause. Trial comparisons, record NCT03852628-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03852628-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.000000000000000006940.0989wilson
Risk in group 2000.102wilson
Risk difference, group 1 minus group 20-0.1020.0989newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 12mg Buprenex and 380mg Vivitrol
2mg Buprenex and 380mg Vivitrol~Buprenex (buprenorphine) 2mg sublingual (SL) (taken every day for 12 weeks) , with Vivitrol (naltrexone) 380mg intramuscular injection (IM) (given every 4 weeks)~2mg Buprenex and 380mg Vivitrol: Daily 2mg SL BUP (84 pills total, taken sublingual every day for 12 weeks) and Q4wks (given intramuscular, 3 injections total: at baseline, week4 and week8 ) IM NLTRX
035EG000
Group 2Placebo
Placebo (SL pill qd, IM injection q4weeks)~Placebo pill (taken sublingual every day for 12 weeks) and IM placebo (given intramuscular injection, every 4 weeks at baseline, week4 and week8)~Placebo (SL pill qd, IM injection q4weeks): Daily SL placebo (84 pills total, taken sublingual every day for 12 weeks) and Q4wks (given intramuscular, 3 injections total: at baseline, week4 and week8) IM Placebo
034EG001

Harm

What it counts
Total, all-cause mortality
Time frame
From baseline visit (after first treatment allocation) through the Week 14 study visit.

Source ClinicalTrials.gov

Trial

Title
Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD
NCT number
NCT03852628
Phases
PHASE2
Conditions
Post Traumatic Stress Disorder, Alcohol Abuse
Interventions
2mg Buprenex and 380mg Vivitrol, Placebo (SL pill qd, IM injection q4weeks)
Lead sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Results first posted
2023-06-07

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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