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 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT02139761
Eligibility Criteria:
Inclusion Criteria:
* men or non-pregnant/non-nursing women between the ages of 18 and 50 years
* meeting criteria for DSM-5 cocaine use disorder
* self-reported cocaine use (intranasal, IV or smoked) averaging at least weekly for the prior six months positive urine drug test for cocaine in the prior month
* HIV seronegative
* EKG without clinically significant abnormality
* normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and resting heart rate (60-90 bpm)
* ability to adhere to the study restrictions and examination schedule
* women with reproductive potential must agree to the use of one of the following birth control methods (oral contraceptives, condom with spermicide, diaphragm, or intrauterine device) during the study and for 2 weeks after last medication dose.
Exclusion Criteria:
* participation in any investigational drug trial or clinical drug trial within 45 days before study entry
* history of clinically significant adverse reaction or hypersensitivity to cocaine or l-THP
* inability to communicate or co-operate with the investigators
* currently taking any prescribed psychoactive medication, e.g., anti- depressant, anti-psychotic, or mood stabilizer
* current clinically significant medical problem that might interfere with safe study participation. This includes pheochromocytoma, untreated hyperthyroidism, dehydration, fever, coronary artery disease, uncorrected congenital heart defect, seizures, electrolyte imbalance, uncontrolled diabetes mellitus, porphyria variegate, superventricular tachycardia, atrial fibrillation, cardiomyopathy, or uncontrolled hypertension.
* current Axis I Major Depression, Schizophrenia, or Bipolar Disorder.
* score below 10/12 on the Evaluation to Sign Consent (ESC)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02139761
Study Brief:
Protocol Section:
NCT02139761