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Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)

Information source: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Methamphetamine Dependence; Methamphetamine Abuse

Intervention: OROS-MPH (Drug); OROS-MPH (Drug); OROS-MPH (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Eugene Somoza, MD, PhD, Principal Investigator, Affiliation: University of Cincinnati
Edward Sellers, MD, PhD, Principal Investigator, Affiliation: Ventana Clinical Research Corporation

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.

Clinical Details

Official title: Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Primary outcome: Safety of the OROS-MPH concurrent with d-methamphetamine infusions.

Secondary outcome: Plasma concentrations

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

Cincinnati Addiction Research Center, Cincinnati, Ohio 45220, United States

Ventana Clinical Research Corporation, Toronto, Ontario M5V2T3, Canada

Additional Information

Starting date: January 2008
Last updated: March 16, 2009

Page last updated: August 20, 2015

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