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

NCT ID: NCT00603434

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Methamphetamine Dependence; Methamphetamine Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

1

Osmotic-Release Methylphenidate

Group Type: EXPERIMENTAL

OROS-MPH

Intervention Type: DRUG

18 mg bid on days 1 and 2

2

Osmotic-Release Methylphenidate

Group Type: EXPERIMENTAL

OROS-MPH

Intervention Type: DRUG

27mg bid on days 3 and 4

3

Osmotic-Release Methylphenidate

Group Type: EXPERIMENTAL

OROS-MPH

Intervention Type: DRUG

35 mg bid on days 5-9

Interventions

OROS-MPH

18 mg bid on days 1 and 2

Intervention Type: DRUG

OROS-MPH

27mg bid on days 3 and 4

Intervention Type: DRUG

OROS-MPH

35 mg bid on days 5-9

Intervention Type: DRUG

Other Intervention Names

Concerta; Concerta; Concerta

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

NIDA

Principal Investigators

Eugene Somoza, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Edward Sellers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ventana Clinical Research Corporation

Locations

Cincinnati Addiction Research Center

Cincinnati, Ohio, United States

Ventana Clinical Research Corporation

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

NIDA-CPU-Methylphenidate-0001

Identifier Type: -

Identifier Source: org_study_id