Clinical trial phase II, randomized, placebo, controlled for crack dependence treatment

• Grant number: 14/24714-5
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: March 01, 2015
• End date: February 29, 2016
• Field of knowledge: Health Sciences - Medicine - Psychiatry
• Principal Investigator: Quirino Cordeiro Júnior
• Grantee: Marcelo Callado Fantauzzi
• Host Institution: Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP). Fundação Arnaldo Vieira de Carvalho. São Paulo , SP, Brazil

Abstract

The addictive behavior is developed as a complex and multifactorial process. The effects of psychoactive drugs in the brain's reward circuitry, as well as the neurobiological complexity of chemical dependence, reveal the advances on new clinical approaches. In this scenario, the optimization of clinical response has been developed with complementary strategies in neuromodulation, such as ETCC and EMT. This study aims a better understanding of the effectiveness of the ETCC in clinical management of the treatment of crack dependence. The study consists in a phase II clinical trial, randomized, double-blind, in which patients selected by inclusion and exclusion criteria will be recruited from the specialized clinics of CAISM. Patients who agree to participate will have ten days of active or sham stimulation. After two and four weeks, they will return for assessments regarding functional aspects and symptom improvements. Primary outcome is the comparison between active and placebo groups, having as reference a pre-determined craving scale. As exploratory disclousers cognitive, anxiety and depression analysis will be made. The main outcome will be measured after four weeks from the end of ten consecutive sessions of ETCC, by means of the scale Cocaine Craving Questionnaire-Brief. It is expected that patients allocated to active stimulation of ETCC exhibit better performance on the Cocaine Craving Questionnaire-Brief than patients allocated to the placebo group.