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

Purpose

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.

Condition	Intervention	Phase
Methamphetamine Dependence Methamphetamine Abuse	Drug: OROS-MPH	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Diagnostic
Official Title:	Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Methylphenidate Methylphenidate hydrochloride Metamfetamine

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Safety of the OROS-MPH concurrent with d-methamphetamine infusions. [ Time Frame: Daily ]

Secondary Outcome Measures:

Plasma concentrations [ Time Frame: Screen, day 2, day 10 ]


Estimated Enrollment:	16
Study Start Date:	January 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Osmotic-Release Methylphenidate	Drug: OROS-MPH 18 mg bid on days 1 and 2 Other Name: Concerta
Experimental: 2 Osmotic-Release Methylphenidate	Drug: OROS-MPH 27mg bid on days 3 and 4 Other Name: Concerta
Experimental: 3 Osmotic-Release Methylphenidate	Drug: OROS-MPH 35 mg bid on days 5-9 Other Name: Concerta

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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:

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Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603434

Locations


United States, Ohio
Cincinnati Addiction Research Center
Cincinnati, Ohio, United States, 45220
Canada, Ontario
Ventana Clinical Research Corporation
Toronto, Ontario, Canada, M5V2T3

Sponsors and Collaborators

University of Cincinnati

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Eugene Somoza, MD, PhD	University of Cincinnati
Principal Investigator:	Edward Sellers, MD, PhD	Ventana Clinical Research Corporation

More Information


Responsible Party:	Liza Gorgon, NIDA
ClinicalTrials.gov Identifier:	NCT00603434 History of Changes
Other Study ID Numbers:	NIDA-CPU-Methylphenidate-0001
Study First Received:	January 16, 2008
Last Updated:	January 11, 2017

Keywords provided by National Institute on Drug Abuse (NIDA):


Methamphetamine

Additional relevant MeSH terms:


Methylphenidate Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action	Dopamine Agents Neurotransmitter Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic Agents Adrenergic Uptake Inhibitors

ClinicalTrials.gov processed this record on July 17, 2017