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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603434
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : January 12, 2017
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Methamphetamine Abuse Drug: OROS-MPH Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
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)
Study Start Date : January 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Plasma concentrations [ Time Frame: Screen, day 2, day 10 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603434

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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)
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Principal Investigator: Eugene Somoza, MD, PhD University of Cincinnati
Principal Investigator: Edward Sellers, MD, PhD Ventana Clinical Research Corporation
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Responsible Party: Liza Gorgon, NIDA Identifier: NCT00603434    
Other Study ID Numbers: NIDA-CPU-Methylphenidate-0001
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: March 2009
Keywords provided by National Institute on Drug Abuse (NIDA):
Additional relevant MeSH terms:
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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