Safety Interaction Trial Ibudilast and Methamphetamine

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 Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment.

The study specific aims are to determine whether ibudilast alters:

1. blood pressure and heart rate responses to methamphetamine;
2. the ratings of craving or other drug experiences from methamphetamine;
3. the reward/reinforcing effects of methamphetamine; and
4. the metabolism of methamphetamine.

Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study.

Conditions

• Methamphetamine-dependence
• Substance Abuse

Interventions

DRUG

Ibudilast 20mg

Ibudilast 20mg BID

DRUG

Ibudilast 50mg

Ibudilast 50mg BID

DRUG

Placebo oral tablet

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• MediciNova

  collaborator INDUSTRY

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Steven Shoptaw, PhD · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• United States

Study Locations