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

Sponsor
University of Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT00603434
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
16
Enrollment
2
Locations
3
Arms
14
Duration (Months)
8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2008
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Osmotic-Release Methylphenidate

Drug: OROS-MPH
18 mg bid on days 1 and 2
Other Names:
  • Concerta

    		•
    Experimental: 2

    Osmotic-Release Methylphenidate

    Drug: OROS-MPH
    27mg bid on days 3 and 4
    Other Names:
  • Concerta

    		•
    Experimental: 3

    Osmotic-Release Methylphenidate

    Drug: OROS-MPH
    35 mg bid on days 5-9
    Other Names:
  • Concerta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of the OROS-MPH concurrent with d-methamphetamine infusions. [Daily]

    Secondary Outcome Measures

    1. Plasma concentrations [Screen, day 2, day 10]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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

    Locations

    Site City State Country Postal Code
    1 Cincinnati Addiction Research Center Cincinnati Ohio United States 45220
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00603434
    Other Study ID Numbers:
    • NIDA-CPU-Methylphenidate-0001
    First Posted:
    Jan 29, 2008
    Last Update Posted:
    Jan 12, 2017
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    Methamphetamine
    Additional relevant MeSH terms:
    Methylphenidate

    Study Results

    No Results Posted as of Jan 12, 2017