Homeopathic medicines as complementary treatment of cocaine dependence.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-67zvt5
• Date of registration: 01/05/2012
• Primary sponsor: Universidade Federal de São Paulo - São Paulo, SP, Brazil
• Public title: Homeopathic medicines as complementary treatment of cocaine dependence.
• Scientific title: Fifty-millesimal potencies of Opium and Erythroxylum coca as complementary treatment of cocaine dependence: pilot, randomized, placebo controlled, double-blind study - COCACRACK-Study
• Date of first enrolment: 12/01/2012
• Target sample size: 50
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-67zvt5/
• Study design: Pilot, randomized, double-blind and controlled with placebo, with two parallel arms.

Countries of recruitment

Brazil

Contacts

• Name: UBIRATAN ADLER
• Affiliation: UNIFESP

• Name: UBIRATAN ADLER
• Affiliation: UNIFESP

Key inclusion & exclusion criteria

Inclusion criteria: Patients between 18 and 65 years, who met DSM-IV TR criteria for cocaine dependence
Capacity and willingness to give informed consent and to comply with study procedures
were also required.
Exclusion criteria: 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; concomitant 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.

Age minimum: 18Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

Cocaine dependence, fissure.
F14.2

F00-F99

Intervention(s)

After inclusion, the fifty patients will be randomly assigned to either Homeopathy other Placebo groups and treated as follows:

Homeopathy:
- treatment as usual from CRATOD and
- Opium Q2 or 2LM - 1 sucrose globule administered orally, once daily, from monday to friday, during weeks 1 and 2, followed by
- Erythroxylum coca Q2 or 2LM - 1 sucrose globule administered orally, once daily, from monday to friday, during weeks 3 and 4,

Placebo: (1 sucrose globule administered orally once daily, from monday to friday, during weeks 1 to 4)

Primary Outcome(s)

Primary efficacy measure is the mean craving score, measured by the first item of the Minnesota Cocaine Craving Scale at week 4.

Secondary Outcome(s)

Secondary end points include the same craving score at weeks 1, 2 and 3 and the remaining craving measures of the Minnesota Cocaine Craving Scale (frequency, duration of craving, changes in relation to previous week and craving response to medication). Tolerability is assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology.

Secondary ID(s)

0413/11

CAAE 0535.0.174.000-11

Source(s) of Monetary Support

Universidade Federal de São Paulo - São Paulo, SP, Brazil

Centro de Referência de Álcool, Tabaco e Outras Drogas da Secretaria de Estado da Saúde - São Paulo, SP, Brazil

Secondary Sponsor(s)

Centro de Referência de Álcool, Tabaco e Outras Drogas da Secretaria de Estado da Saúde - São Paulo, SP, Brazil