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 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT01030692
Eligibility Criteria:
Inclusion Criteria:
* Be a cocaine-dependent volunteer who is non-treatment-seeking
* Meets DSM-IV criteria for cocaine dependence as determined by SCID, and has provided at least one cocaine-positive urine specimen within the 2 weeks prior to enrollment
* Be male or female, between 18 and 55 years old
* Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
* Female subjects must be non-nursing and postmenopausal, have had a hysterectomy, undergone tubal ligation, or have a negative pregnancy test and agree to use one of the birth control methods below
* Agreeable to conditions of the study and likely to complete schedule of interventions and measures
* Has medical history, physical exam, and screening laboratory results that demonstrate no contraindication to participation
Exclusion Criteria:
* Has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure
* Has a current psychiatric disorder other than cocaine abuse or dependence, including major depression, bipolar disorder, schizoaffective disorder, schizophrenia, organic brain disease, or dementia
* Meets DSM-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics
* Receiving opiate-substitution therapy (methadone, LAAM, or buprenorphine) within 2 mo's of enrollment
* Has a current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, febrile seizures, or family history of seizure disorder
* Has a diagnosis of adult (i.e., 21 years or older) asthma, or chronic obstructive pulmonary disease, including a history of acute asthma within the past two years, and those with current or recent (with the past two years) treatment with an inhaled or oral b-adrenergic agonist
* Has had head trauma that resulted in neurological sequelae (e.g., loss of memory for greater than 5 min or that required hospitalization)
* Has an unstable medical condition, which, in the judgment of investigators, would make participation hazardous, including, but not limited to, AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency (serum bilirubin or creatinine exceeding 1.5 the upper limit of normal, respectively)
* Be pregnant or lactating (nursing), or a fertile woman not practicing adequate methods of contraception or planning to become pregnant within one month of conclusion of the study
* Has current suicidal ideation or plan as assessed by SCID or MINI interview
* Has clinically significant ECG abnormalities, including QTc interval prolongation \>450 ms in men or \>480 ms in women
* In the opinion of the PI, be expected to fail to complete the study protocol due to probable incarceration or relocation from the clinic area
* Has clinically significant laboratory values (outside of normal limits), in the judgment of the PI
* Is on parole, probation or has any legal obligations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01030692
Study Brief:
Protocol Section:
NCT01030692