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 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT00495092
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of intranasal cocaine dependence, according to DSM-IV-TR criteria
* age between 18 and 60 years
* current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission.
* demonstrated capacity to grant informed consent and sign the pertinent informed consent form.
* place of residence compatible with attendance at the centre.
* for women, willingness to use effective contraceptive measures during the study.
Exclusion Criteria:
* diagnosis of a severe medical disorder that could interfere with the study
* presence of an organic pathology for which methylxanthines or biperidene, iodine or apomorphine administration is contraindicated
* serum liver transaminase levels 3 times higher than normal values
* pregnancy and breast-feeding
* neuroleptic medication treatment in the past 6 weeks
* current treatment, or anticipation that the patient may need to initiate treatment during the study with drugs that may interact with study medication.
* current diagnosis of a major mental disorder.
* awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence)
* current participation in another research project.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00495092
Study Brief:
Protocol Section:
NCT00495092