NCT00603434

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2008

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 12, 2017

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

January 16, 2008

Last Update Submit

January 11, 2017

Conditions

Methamphetamine DependenceMethamphetamine Abuse

Keywords

Methamphetamine

Outcome Measures

Primary Outcomes (1)

  • Safety of the OROS-MPH concurrent with d-methamphetamine infusions.

    Daily

Secondary Outcomes (1)

  • Plasma concentrations

    Screen, day 2, day 10

Study Arms (3)

1

EXPERIMENTAL

Osmotic-Release Methylphenidate

Drug: OROS-MPH

2

EXPERIMENTAL

Osmotic-Release Methylphenidate

Drug: OROS-MPH

3

EXPERIMENTAL

Osmotic-Release Methylphenidate

Drug: OROS-MPH

Interventions

OROS-MPHDRUG

18 mg bid on days 1 and 2

Also known as: Concerta
1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Please contact site for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cincinnati Addiction Research Center

Cincinnati, Ohio, 45220, United States

Location

Ventana Clinical Research Corporation

Toronto, Ontario, M5V2T3, Canada

Location

MeSH Terms

Interventions

Methylphenidate

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eugene Somoza, MD, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

  • Edward Sellers, MD, PhD

    Ventana Clinical Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 12, 2017

Record last verified: 2009-03

Locations

CA(1)US(1)