- Research Article
- 10.51910/ijhdr.v25icf.1573
Homeopathy on the integrative care of cocaine-related disorders (Cocacrack-3 Study): Updated Protocol for a randomized, placebo-controlled, double-blind, crossover clinical trial
- Oct 10, 2025
- International Journal of High Dilution Research - ISSN 1982-6206
- Ubiratan Cardinalli Adler + 14 more +14
Background: Effective pharmacotherapy for Cocaine Use Disorder is needed. The Cocacrack-2 study showed that homeopathic fifty-millesimal potencies of Opium and Erythroxylum coca were more effective than a placebo in reducing cocaine/crack use. However, the study experienced high dropout rates, which are common in the study population but could introduce bias. Therefore, further research is needed, focusing on strategies to ensure trial patient retention. The Cocacrack-3 study protocol initially aimed to improve retention through home visits from Primary Care. However, due to the COVID-19 pandemic, we revised the protocol to utilize specialized facilities with network support and telemedicine follow-up to enhance retention. Objectives: 1) Assess the effectiveness and safety of sequential administration of homeopathic potencies (LM2, LM4, LM6) of Opium and Erythroxylum coca in reducing cocaine use. 2) Evaluate the effectiveness of telemedicine and support networks in enhancing treatment retention. Setting: Psychosocial Attention Centers for Alcohol and other Drugs (CAPS-AD) in Florianópolis, São José, and Palhoça, Brazil. Study center: Research Laboratory for the History of Nursing and Health Knowledge at the Federal University of Santa Catarina. Methods: Randomized, placebo-controlled, double-blind, crossover clinical trial (six weeks per participant). Hypothesis: H0: No significant difference between homeopathic potencies and placebo. H1: Significant difference between homeopathic potencies and placebo. Inclusion criteria: Men and women aged 18-70, patients at CAPS-AD, with a support network. Exclusion criteria: Remission of cocaine use > two weeks, inability to participate virtually. Sample size: 120 participants, randomized 1:1 to verum or placebo sequences. Interventions: LM2, LM4, LM6 potencies of Opium and Erythroxylum coca, or placebo. Primary measure: Percentage of cocaine use days at week 3. Secondary measures: Cocaine use days, craving, progression, concomitant medications, adverse events, treatment adherence, and participant retention.
Read more