Clavulanic acid is associated with moderation of cigarette use in patients with cocaine use disorder: A post-hoc analysis.

objectiveA 12 week trial examined clavulanic acid (CLAV) as a cocaine use disorder (CUD) treatment. This post-hoc analysis explored CLAV effects on cigarette smoking among participants with a focus on the impact of adverse childhood experiences on treatment response.

methodsAdults who met DSM-5 criteria for CUD and reported cigarette smoking during screening were included. Initially, participants self-administered 500mg CLAV or matched placebo daily for 4 weeks. If cocaine use continued, CLAV was increased to 750mg at week 5. The Adverse Childhood Experience (ACE) scale was administered at baseline. Changes in self-reported smoking between treatment groups were compared.

resultsSixty-seven percent of participants reported smoking cigarettes at screening (n = 43; 28 CLAV, 15 placebo). Subjects had a median age of 52.5 years, were predominantly male (77%), and their median weekly cocaine expenditure was $300. The median baseline cigarettes per week was 37. There were 36 individuals in the low ACE (0-3) group and 7 in the high ACE (4 +) group. Using a mixed-effects regression model, subjects with low ACE scores significantly reduced average cigarettes smoked per week compared to screening with CLAV treatment compared with placebo. Subjects with high ACE scores treated with CLAV smoked more cigarettes on average per week compared with screening than placebo counterparts.

conclusionsThough exploratory, this provides initial evidence that CLAV treatment may moderate cigarette smoking in individuals with CUD depending on their ACE exposure. Further research is warranted to validate these results.