Methamphetamine Abuse, Methamphetamine Dependence
Conditions
Keywords
Methamphetamine
Brief summary
This is a human inpatient clinical pharmacology study to assess potential interactions between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate (OROS-MPH). The primary objective of this study is to determine the safety of the OROS-MPH concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures include cardiovascular responses \[heart rate (HR), blood pressure (BP), and electrocardiograph (ECG) measurements\], oral temperature, adverse events (AEs), and clinical laboratory analyses.
Interventions
DRUGOROS-MPH
18 mg bid on days 1 and 2
Sponsors
National Institute on Drug Abuse (NIDA)
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the OROS-MPH concurrent with d-methamphetamine infusions. | Daily |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations | Screen, day 2, day 10 |
Countries
Canada, United States
Outcome results
None listed