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Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), January 2008
Sponsors and Collaborators: University of Cincinnati
National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00603434
  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 I

MedlinePlus related topics: Methamphetamine
Drug Information available for: Methylphenidate hydrochloride Methylphenidate Amphetamine Methamphetamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title: Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations [ Time Frame: Screen, day 2, day 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: January 2008
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Osmotic-Release Methylphenidate
Drug: OROS-MPH
18 mg bid on days 1 and 2
2: Experimental
Osmotic-Release Methylphenidate
Drug: OROS-MPH
27mg bid on days 3 and 4
3: Experimental
Osmotic-Release Methylphenidate
Drug: OROS-MPH
35 mg bid on days 5-9

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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:

  • Please contact site for more information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603434

Contacts
Contact: Eugene Somoza, M.D., Ph.D. 513-487-7800 somoza@uc.edu

Locations
United States, Ohio
Cincinnati Addiction Research Center Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Eugene Somoza, MD, PhD     513-487-7800     somozae@email.uc.edu    
Principal Investigator: Eugene Somoza, MD, PhD            
Canada, Ontario
Ventana Clinical Research Corporation Not yet recruiting
Toronto, Ontario, Canada, M5V2T3
Contact: Edward Sellers, MD, PhD     416-963-9338 ext 308     e.sellers@dlcrc.com    
Principal Investigator: Edward Sellers, MD, PhD            
Sub-Investigator: Myroslava Romach, MSc, MD            
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Eugene Somoza, MD, PhD University of Cincinnati
Principal Investigator: Edward Sellers, MD, PhD Ventana Clinical Research Corporation
  More Information

Responsible Party: NIDA ( Liza Gorgon )
Study ID Numbers: NIDA-CPU-Methylphenidate-0001
Study First Received: January 16, 2008
Last Updated: January 28, 2008
ClinicalTrials.gov Identifier: NCT00603434  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Methamphetamine
Dopamine
Methylphenidate
Amphetamine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009