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Status:

COMPLETED

Safety Interaction Trial Ibudilast and Methamphetamine

Lead Sponsor:

University of California, Los Angeles

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

MediciNova

Conditions:

Methamphetamine-dependence

Substance Abuse

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief Summary

This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Kore...

Detailed Description

This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Kore...

Eligibility Criteria

Inclusion

  • NOT seeking treatment for methamphetamine problems;
  • English-speaking;
  • Age 18-55;
  • Meet SCID criteria for MA dependence;
  • Self-reported history of MA use via injection or smoking AND at least one MA positive urine drug screening during eligibility;
  • Resting heart rate 50-100BPM; Systolic BP 105-150 mm Hg; Diastolic BP 45-90 mm Hg stabilized within 2 days of admission;
  • Baseline EKG demonstrating normal sinus rhythm, normal conduction, no clinically significant arrhythmias;
  • Use of acceptable barrier method of birth control;
  • If female, not pregnant or lactating;
  • Have medical history and physical examination demonstrating no additional clinically significant contraindications for study participation, in judgment of investigators.

Exclusion

  • Current dependence on cocaine, opioids, marijuana, or alcohol;
  • Liver function tests GE 3x upper limit of normal, or kidney function tests GE 2x the upper limit of normal;
  • Current or past history of seizure disorder;
  • History of head trauma;

Key Trial Info

Start Date :

January 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2013

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT01217970

Start Date

January 1 2011

End Date

March 1 2013

Last Update

May 15 2023

Active Locations (1)

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Harbor-UCLA Medical Center GCRC

Torrance, California, United States, 90502