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

Methamphetamine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603434
• Other study ID #: NIDA-CPU-Methylphenidate-0001
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2008
• Last updated: January 11, 2017
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Methamphetamine Abuse
• Methamphetamine Dependence

Intervention

Drug:
• OROS-MPH
18 mg bid on days 1 and 2
• OROS-MPH
27mg bid on days 3 and 4
• OROS-MPH
35 mg bid on days 5-9

Locations

Country	Name	City	State
Canada	Ventana Clinical Research Corporation	Toronto	Ontario
United States	Cincinnati Addiction Research Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the OROS-MPH concurrent with d-methamphetamine infusions.		Daily	Yes
Secondary	Plasma concentrations		Screen, day 2, day 10	No