Comparison · NCT03852628-08e8319b
2mg Buprenex and 380mg Vivitrol vs Placebo: Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms
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: Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms. Trial comparisons, record NCT03852628-08e8319b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03852628-08e8319b
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.357 | 0.207 | 0.542 | wilson | |
| Risk in group 2 | 0.444 | 0.276 | 0.627 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0873 | -0.324 | 0.163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.804 | 0.419 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 0.694 | 0.235 | 2.05 | log | |
| Number needed to treat, for one fewer participant with the outcome on 2mg Buprenex and 380mg Vivitrol than on Placebo | 11.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 2mg 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 | 10 | 28 | OG000 |
| Group 2 | Placebo | 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 | 12 | 27 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms
- Description
AUD is measured by the Timeline Follow Back (TLFB). This instrument documents the amount of daily alcohol consumption (in grams) and categorizes the World Health Organization Risk Levels of Alcohol Use. The are 4 different WHO Risk Levels: Very High Risk, High Risk, Medium Risk, and Low Risk (including abstinence). An AUD reduction is defined as a WHO risk reduction of at least one category from baseline to week 8. PTSD symptom is measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). This 30-item interview assesses PTSD diagnosis and symptom severity. The CAPS-5 Total Symptom Severity Score (TSSS) ranges from 0 to 80, with higher scores indicating worse symptoms. A reduction in PTSD symptom is defined as a 10+ point decrease in the TSSS from baseline to week 8. A positive response for the composite primary outcome measure is defined as at least a 1-category risk reduction on the WHO s and at least a 10-point decrease in TSSS from baseline to Week 8.
- Time frame
- Baseline and 8 Weeks
- Population
Includes all randomized participants that completed the baseline and Week 8 visit, and reported enough consecutive days of alcohol consumption at the week 8 visit (defined as being within one standard deviation of the population mean for the 28-day look back period).
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03852628?tab=results
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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