Homeopathy on the integrative care of cocaine-related disorders (Cocacrack-3 Study): Updated Protocol for a randomized, placebo-controlled, double-blind, crossover clinical trial
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.019 | 0.017 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.003 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.006 | 0.006 |
| Insufficient payload (model declined to judge) | 0.046 | 0.010 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".