Cocaine dependence
Conditions
Interventions
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
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 gr
- inert sucrose globules indistinguishable from the verum above.
Drug
Sponsors
Unidade de Saúde Escola (USE) da Universidade Federal de São Carlos/UFSCAR
Centro de Atenção Psicossocial Álcool e Drogas de São Carlos-SP
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Cocaine abstinence at inclusion interview; disabling clinical or psychiatric diseases that would hinder regular participation in the study. Acupunture or homeopathic treatment simultaneously to the study; simultaneous participation in another clinical trial; pregnancy; patients who are assumed to have a linguistic, intellectual or any other reason for not understanding the meaning of the clinical trial and for not complying with the necessary study procedures. Patients that after inclusion and first medical visit do not return for any visit will be excluded and their data will not be used for statistical analysis only for "lost to follow-up" total. Motivation for change will be briefly assessed and subjects in precontemplation or contemplation states regarding cocaine and/or crack dependence will not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactUbiratan Adler
Unidade de Saúde Escola da Universidade Federal de São Carlos
Outcome results
None listed