Homeopathy in the cocaine-crack dependence.

INTERVENTION: E02.190.388 The 52 patients randomized to the Homeopathy group will be treated as follows: ‐ CAPS‐AD treatment as usual; ‐ fifty millesimal potencies of Opium (LM2 at weeks 1 and 2; LM3 at weeks 3 and 4; LM 4 at weeks 5 and 6 and LM5 at weeks 7 and 8),given in sucrose globules to be dissolved on the tongue, once daily. ‐ fifty millesimal potencies of Erythroxylum coca (LM2 at weeks 1 and 2; LM3 at weeks 3 and 4; LM 4 at weeks 5 and 6 and LM5 at weeks 7 and 8), given in sucrose globules to be dissolved on the tongue, three times daily and in case of craving. The 52 patients randomized to the Placebo group group will be treated as follows: ‐ CAPS‐AD treatment as usual; ‐ inert sucrose globules indistinguishable from the verum above. CONDITION: Cocaine dependence ; F14.2 F00‐F99 PRIMARY OUTCOME: Primary efficacy measure will be the increase of the mean of abstinent days at weeks 7 and 8 assessed by means of a standardized consumption sheet. SECONDARY OUTCOME: Increase in the mean of abstinent days; reduction in cocaine craving (assessed by means of Minnesota Cocaine Craving Scale) and improvement in quality of life (assessed by 12‐Item Short‐Form Health Survey). Tolerability will be assessed by adverse events reported in both groups during the 8 weeks of study duration. INCLUSION CRITERIA: 104 patients who meet the criteria for cocaine dependence from the International Statistical Classification of Diseases and related health problems 10th revision ‐ World Health Organization. Fixed address; capacity and willingness to give informed consent and to comply with study procedures were also required.