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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00585520
Eligibility Criteria:
Inclusion Criteria:
* Female and males, aged 18 to 50 years
* Able to read and write
* Meet current DSM-IV criteria for cocaine dependence; and report current cocaine use of at least once a week or more; confirmation of cocaine use via positive urine test at initial assessment and upon inpatient admission.
* For women, regular menses every 25-35 days
* In good health as verified by medical history, screening examination, and screening laboratory tests
* For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives
Exclusion Criteria:
* History of major medical illnesses; including liver diseases, abnormal vaginal bleeding, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study
* Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder; Meet current criteria for dependence on another psychoactive substance, excluding nicotine and caffeine; Any current use of opiates or past history of opiate abuse/dependence.
* For women, amenorrhea
* Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00585520
Study Brief:
Protocol Section:
NCT00585520