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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT01557569
Eligibility Criteria:
Inclusion Criteria.
* 18-65 years old
* Seeking treatment for METH use
* METH dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
* At least weekly self-reported METH use during a preceding three month period
* Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing, and not be nursing
* Men must agree to use effective means of contraception during the study.
Exclusion Criteria.
* Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
* Current opioid, alcohol or sedative physical dependence or cocaine dependence
* Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, hypertension \[i.e., \> 160 SBP or \> 100 DBP\] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
* Schizophrenia or bipolar disorder of any type
* Present or recent use (within 2 weeks) of over-the-counter or prescription drug that would be expected to have major interaction with atomoxetine (e.g., an monoamine oxidase inhibitor (MAOI), paroxetine, fluoxetine, quinidine, dopamine, albuterol, or other β2-agonists)
* Medical contraindication to receiving atomoxetine (e.g., severe hepatic impairment, glaucoma, heart disease, hypertension, seizure disorders, documented hypersensitivity to atomoxetine); or other bronchospastic condition, (2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to atomoxetine)
* Liver function tests (i.e., liver enzymes) greater than two times normal levels
* Systolic blood pressure of \< 90 or \> 160 mmHg, diastolic blood pressure of \< 60 or \> 100 mmHg, or sitting heart rate of \< 55 or \> 100 beats/min or blood pressure readings \> 140 systolic or \> 90 diastolic on three separate, consecutive occasions.
* History of pheochromocytoma
* Pregnant or nursing female
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01557569
Study Brief:
Protocol Section:
NCT01557569