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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01038232
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Be between the ages of 18 and 55.
2. Be in good health.
3. Be right-handed.
4. Cocaine dependent participants: Endorse regular cocaine use (i.e., greater than or equal to 2 times per week) in the past year.
5. Non-drug using controls: will be matched to the cocaine using participants with respect to age, gender, IQ, socioeconomic factors, and years of education.
EXCLUSION CRITERIA:
1. Pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing age before each experimental session.
2. Have implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia rendering them unable to undergo fMRI scanning.
3. Have major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, syncope, history of superficial or deep vein thrombosis, HIV, or other clinically significant infectious diseases.
4. Have current major psychiatric disorders to include, but not limited to, mood, anxiety, borderline personality disorder, psychotic disorders, or substance-induced psychiatric disorders,
5. Have neurological illnesses including, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor.
6. Control participants: Meet DSM-IV criteria for any past or current substance abuse or dependence; use of illicit substances in the last 30 days or nicotine if use is greater than 10 cigarettes per day and/or Fagerstrom score is greater than 3.
7. Cocaine using participants:
1. Non-treatment subjects: Meet DSM-IV criteria for substance dependence on any substance other than nicotine or cocaine in the month prior to study enrollment. Only (except nicotine or cocaine dependence will be allowed in the month prior to enrollment. Current abuse on any substance will be acceptable.). While it might be preferable to exclude individuals whose use of other substances reaches the threshold of abuse, inclusion of such individuals will not necessarily contaminate the data.
2. Inpatient cocaine subjects: Those who meet DSM-IV TR criteria for the course specifier In a Controlled Environment may have a history of dependence on substances other than cocaine before their admission to the inpatient treatment program.
8. Regular use of any prescription, over-the-counter, or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling. Medications that could interfere with the BOLD signal include compounds that have been shown to be vasoactive, including alpha agonists, beta blockers, and calcium channel blockers.
9. Have cognitive impairment as assessed by screening WASI vocabulary subtest below 48, corresponding to full IQ of 85 (in that case on screening, a full WASI will be done to verify IQ of 85 or above).
10. Acute drug intoxication or positive urine drug screen at the beginning of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01038232
Study Brief:
Protocol Section:
NCT01038232