Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00603434
First received: January 16, 2008
Last updated: March 16, 2009
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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 ] [ 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
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
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

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

No publications provided

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: March 16, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 23, 2013