Cocaine crack addiction.
Conditions
Interventions
This is a double blind study. Subjects: We wil select individuals with crack cocaine addiction diagnosis, males, and with minimum age of 18 years, and maximum age 50 years old, and capable of consenti
Drug
HP3.073.433.101
Sponsors
Universidade Federal do Tocantins
Secretaria Municipal da Saúde de Palmas
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Exclusively dependence of crack cocaine. Male gender. Aged between 18-50 years.
Exclusion criteria
Exclusion criteria: Neurological diseases and serious mental disorder. Volunteers already under use of drug therapy for addictions to the crack cocaine. Of multiple drugs users, substance dependents addition to the crack cocaine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that 70% of the group that is free of the use topiramate use of crack after 12 weeks of therapy. It is expected that 20% of the placebo group is free of drug after 12 weeks of therapy. This is to be used as a method to measure the urine test for cocaine. It wil be cataloged the number of such subject result in each group (or arm). | — |
Secondary
| Measure | Time frame |
|---|---|
| Even after the patient has no discontinuated the crack cocaine use it is expected that individuals who use topiramate to reduce by 80% the number of days a week (frequency) making use of the drug. This will be assessed the average number of days per week that the patient remains without the drug: Will be checked through the patient's account in diary and interview with their families the average number of days (each week for 12 weeks) that was without using the drug each week. The average number will be added to each individual average of each group (or arm).;Even after the patient has no discontinuated the crack cocaine use it is expected that individuals who use topiramate to reduce by 80% the average weekly amount (number) that causes the drug. This will be assessed the average number of drugs consumed per week: Will be checked through the patient's account in diary and interview with their families the average amount (each week for 12 weeks) of drug consumed each week. The average number will be added to each individual average of each group (or arm). Will be considered the amount in grams. When the patient does not know tell the exact weight, this value will be estimated by standardizing the weight of 1 gram each stone to crack.;It is expected that the group that makes use of topiramate few side effects present in the same proportion as the use placebo group. This will be evaluated weekly side effects: Will be checked through the patient's account in diary and interview with their relatives the presence of side effects (each week for 12 weeks) with the use of medications in each week, even for the placebo group. Will be cataloged any side effects reported by the patient. | — |
Countries
Brazil
Contacts
Public ContactLeonardo ;Thaynne Baldaçara;Diniz
Universidade Federal do Tocantins;Universidade Federal do Tocantins
Outcome results
None listed