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:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
NCT ID:
NCT03953612
Eligibility Criteria:
Inclusion Criteria:
* Male or female individuals, ages 18 to 60.
* Subjects must meet current DSM-V criteria for cocaine use disorder; documented positive urine toxicology screen for cocaine at intake or collateral information from family members, significant others, room-mates etc., on recent use.
* Subject has voluntarily given informed consent and signed the informed consent document.
* Able to read English and complete study evaluations.
Exclusion Criteria:
* Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
* Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/PCP, excluding alcohol and nicotine.
* Any current use of opiates or past history of opiate use disorder.
* Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
* Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
* Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
* Abstinent from cocaine for more than two weeks prior to admission.
* Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03953612
Study Brief:
Protocol Section:
NCT03953612