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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01392092
Eligibility Criteria:
Inclusion Criteria:
* Male and female volunteers (18-55 years of age)
* Must meet DSM-IV criteria for current Cocaine Abuse or Dependence and wish to participate in research.
* Positive urine test for cocaine.
* Candidates must be in good health to be eligible.
* All candidates must receive routine medical (history and physical) exam with standard laboratory tests (complete blood chemistry, urinalysis, urine pregnancy test for females, tuberculin screening), and 12-lead ECG at the initial screening visit.
Exclusion Criteria:
* Serious psychiatric illness (e.g. psychosis, bipolar, suicide attempts, major depression that is not substance-induced).
* Substance use disorder other than cocaine abuse or dependence, nicotine dependence, alcohol abuse, sedative abuse or marijuana abuse.
* Neurological diseases (e.g. stroke, seizures); cardiovascular problems (e.g. myocardial infarction, angina, systolic BP \>160 or \<95 mmHg, diastolic BP \>95 mmHg, or clinically abnormal ECG); pulmonary diseases (e.g. asthma, TB); systemic diseases (e.g. hepatitis, autoimmune diseases).
* Cognitive impairment.
* Exposed in past 30 days to medications that would increase study risk (e.g. toxicity to major organ systems, psychotropics, asthma inhalers, or interactions with study drugs).
* Pregnant (urine HCG), lactating (self-report), or if heterosexually active and not using (self-report) medically approved birth control measures (oral or depot contraceptives, IUD, condom/foam, sterilization, tubal ligation).
* Seeking treatment or being treated for a substance use disorder.
* Metal objects in body (e.g. metal plates, part of a bullet from a gunshot wound, or a catheter).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01392092
Study Brief:
Protocol Section:
NCT01392092