Fig. 5: Results of the RCT in subjects with AUD. | Translational Psychiatry

Fig. 5: Results of the RCT in subjects with AUD.

From: Histamine H3 Receptor as a target for alcohol use disorder: challenging the predictability of animal models for clinical translation in drug development

Fig. 5

a Effect of BP1.3656B in reducing the number of monthly Heavy Drinking Days (nHDDs) during 12-week double-blind period (primary endpoint). Adjusted mean (±SE) nHDDs at 12-week. Statistics: analysis of covariance (ANCOVA) on the value at 12-week with imputation, adjusting for baseline value and with treatment considered as a fixed factor and the centre effect added as a random factor. A step-down strategy was performed to assess the significance of doses, which were tested starting with the highest and considering the lowest based on the significance effect of the previous dose. b Effect of BP1.3656B on the Total daily Alcohol Consumption (TAC) from baseline to the end of treatment (secondary endpoint). Adjusted mean (± SE) TAC at 12-week. Statistics: analysis of covariance (ANCOVA) on the value at 12-week with imputation, adjusting for baseline value and with treatment considered as a fixed factor. A step-down strategy was performed to assess the significance of doses, which were tested starting with the highest and considering the lowest based on the significance effect of the previous dose. c Effect of BP1.3656B on the Percent of Abstinent Days (PAD) during 12-week double-blind period (secondary endpoint). Adjusted mean (± SE) PAD at 12-week. Statistics: analysis of covariance (ANCOVA) on the value at 12-week with imputation, adjusting for baseline value and with treatment considered as a fixed factor. A step-down strategy was performed to assess the significance of doses, which were tested starting with the highest and considering the lowest based on the significance effect of the previous dose. d Effect of BP1.3656B on the 4-week point prevalence abstinence (PPA) at the end of treatment (secondary endpoint). Adjusted mean (±SE) 4 week point prevalence abstinence at 12-week. Statistics: analysis of covariance (ANCOVA) on the value at 12-week with data missing imputation, adjusting for baseline value and with treatment considered as a fixed factor. A step-down strategy was performed to assess the significance of doses, which were tested starting with the highest and considering the lowest based on the significance effect of the previous dose.

Back to article page