Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT01397266
Eligibility Criteria:
Inclusion criteria:
1. Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
2. 20 days or less withdrawal
3. 18-35 years old.
4. If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
5. Fixed residential address in Sao Paulo
Exclusion criteria:
1. Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).
2. organic brain disease, neurosurgery to implant metal clip or epilepsy.
3. severe uncontrolled clinical comorbidity.
4. use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.
5. Changes clinically significant laboratory findings. 13
6. Condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study.
7. Mandate that mandating the judicial treatment for cocaine dependence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01397266
Study Brief:
Protocol Section:
NCT01397266