Homeopathy for Cocaine-Related Disorders: Implementing a Study Protocol in Primary Care (Cocacrack-3 Study Protocol)

Abstract

Introduction: Previous results showed a significant decrease in cocaine-using days among cocaine users treated homeopathic fifty-millesimal (LM) potencies of Opium and Erythroxylum coca, as compared to placebo. Those results might have been biased by low adhesion of crack-cocaine users to treatment, trend that has been observed in clinical trials and practice, usually performed in specialized services. Objectives: to investigate 1) the effectiveness and tolerability of LMpotencies of Opium and Erythroxylum coca for cocaine-related disorders and 2) the effectiveness of a qualified primary care setting in increasing treatment attendance and retention. Methods: A randomized, placebo-controlled, double-blind, crossover clinical trial with twelve-week study duration per patient will be performed. 120 participants aged between 18 and 60 years, with Assist score for cocaine between 4 and 26 will be included. Exclusion criterion: urinary benzoylecgonine < 150 ng/mL. Participants will receive verum for 6 weeks followed by placebo for 6 weeks, or vice-versa. Primary endpoint: percentage of reported number of cocaine using days at week 6. Secondary endpoints: percentage of reported number of cocaine using days during participation in the study; percentage of positive benzoylecgonine samples; cocaine craving score, daily craving episodes number, craving episodes mean duration, patient perception of medication action favoring craving reduction (assessed by Minnesota Cocaine Craving Scale); Assist score for cocaine; treatment attendance; retention in treatment; Adverse Events. Discussion: For the first time, this study utilizes a primary care setting as a platform to increase treatment adhesion of cocaine users and assess the effectiveness of homeopathy for cocaine-related disorders.