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

January 11, 2017 updated by: University of Cincinnati

Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5V2T3
        • Ventana Clinical Research Corporation
  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati Addiction Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Osmotic-Release Methylphenidate
Drug: OROS-MPH
18 mg bid on days 1 and 2
Other Names:
  • Concerta
Drug: OROS-MPH
27mg bid on days 3 and 4
Other Names:
  • Concerta
Drug: OROS-MPH
35 mg bid on days 5-9
Other Names:
  • Concerta
Experimental: 2
Osmotic-Release Methylphenidate
Drug: OROS-MPH
18 mg bid on days 1 and 2
Other Names:
  • Concerta
Drug: OROS-MPH
27mg bid on days 3 and 4
Other Names:
  • Concerta
Drug: OROS-MPH
35 mg bid on days 5-9
Other Names:
  • Concerta
Experimental: 3
Osmotic-Release Methylphenidate
Drug: OROS-MPH
18 mg bid on days 1 and 2
Other Names:
  • Concerta
Drug: OROS-MPH
27mg bid on days 3 and 4
Other Names:
  • Concerta
Drug: OROS-MPH
35 mg bid on days 5-9
Other Names:
  • Concerta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of the OROS-MPH concurrent with d-methamphetamine infusions.
Time Frame: Daily
Daily

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations
Time Frame: Screen, day 2, day 10
Screen, day 2, day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 16, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CPU-Methylphenidate-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Methamphetamine Dependence

Clinical Trials on OROS-MPH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe