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

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: January 16, 2008
Last updated: January 11, 2017
Last verified: March 2009
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: Triple (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:

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
18 mg bid on days 1 and 2
Other Name: Concerta
Experimental: 2
Osmotic-Release Methylphenidate
27mg bid on days 3 and 4
Other Name: Concerta
Experimental: 3
Osmotic-Release Methylphenidate
35 mg bid on days 5-9
Other Name: Concerta


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  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 identifier: NCT00603434

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)
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 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):

Additional relevant MeSH terms:
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
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors processed this record on August 23, 2017