Comparison · NCT02966873-sae
N-Acetylcysteine (NAC) Treatment Group vs Placebo Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. N-Acetylcysteine (NAC) Treatment Group vs Placebo Group: serious adverse events. Trial comparisons, record NCT02966873-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02966873-sae
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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 | 0.0538 | 0.0232 | 0.12 | wilson | |
| Risk in group 2 | 0.0337 | 0.0115 | 0.0945 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0201 | -0.048 | 0.0897 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.59 | 0.393 | 6.48 | log | |
| Odds ratio, group 1 over group 2 | 1.63 | 0.378 | 7.03 | log | |
| Number needed to harm, for one more participant with a serious adverse event on N-Acetylcysteine (NAC) Treatment Group than on Placebo Group | 49.9 | 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 | N-Acetylcysteine (NAC) Treatment Group | Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.~The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.~Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring. | 5 | 93 | EG000 |
| Group 2 | Placebo Group | Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.~The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.~Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring. | 3 | 89 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
Source ClinicalTrials.gov
Trial
- Title
- Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)
- NCT number
- NCT02966873
- Phases
- PHASE2
- Conditions
- Post Traumatic Stress Disorder (PTSD), Addiction, Alcohol Abuse
- Interventions
- N-Acetylcysteine (NAC) Treatment, Cognitive Behavioral Therapy (CBT), Inactive Placebo Oral Capsule, Functional magnetic resonance imaging (fMRI), Proton magnetic resonance spectroscopy (MRS) Imaging
- Lead sponsor
- Medical University of South Carolina
- Results first posted
- 2023-04-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02966873?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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