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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT00603434
Eligibility Criteria:
Inclusion Criteria:
* Be volunteers who meet DSM-IV criteria for methamphetamine abuse or dependence determined using a Mini-International Neuropsychiatric Interview (MINI) and be non-treatment seeking at time of study and have a positive urine test for methamphetamine (greater than or = to 500 ng/mL) during screening.
* Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
* Have a negative urine test for methamphetamine and other drugs of abuse (opiates, cocaine, and benzodiazepines) after clinic intake before the first infusion session.
* Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the site Principal Investigator
* Have vital signs as follows: resting heart rate between 45 and 100 bpm, systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg.
* Have electrolytes (Na, K, Cl, HCO3) and hematocrit that is clinically normal (+/- 10% of laboratory limits).
* Have liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) less than three times the upper limit of normal.
* Have kidney function tests (creatinine and BUN) less than twice the upper limit of normal.
* Have an ECG performed that demonstrates sinus rhythm between 45 and 100 beats per minute (bpm), normal conduction, and no clinically significant arrhythmias.
* Be able to swallow whole tablets of OROS-MPH due to the controlled release formulation.
* If female, have a negative pregnancy test and agree to use one of the following methods of birth control, or be postmenopausal, have had a hysterectomy or have been sterilized. Birth control must be in effect starting at least 7 days (14 days for hormone-based methods used alone) prior to clinic intake, and should extend at least until the last follow-up visit.
Exclusion Criteria:
* Please contact site for more information
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00603434
Study Brief:
Protocol Section:
NCT00603434