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

Graphical Abstract-002
Ubiratan Cardinalli Adler, Noemia Liege Maria da Cunha Bernardo, Karen Berenice Denez, João Gabriel Bernardo Bueno, Clarice Maria Specht, Maria Celina Ribeiro Lenzi, Angela Maria da Silva Hoepfner, Janayna Sobota, Simone do Nascimento Gonçalves, Amarilys de Toledo Cesar, Maristela Schiabel Adler1, Erlandson Uchoa Lacerda, Edson Zangiacomi Martinez and José Carlos Fernandes Galduróz



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.

Published on: June 01, 2020
doi: 10.17756/jas.2020-S1-002
Citation: Adler UC, da Cunha Bernardo NLM, Denez KB, Bueno JGB, Specht CM, et al. 2020. Homeopathy for Cocaine-Related Disorders: Implementing a Study Protocol in Primary Care (Cocacrack-3 Study Protocol). J Addict Sci 6S(1): S5-S11.