Safety Interaction Trial Ibudilast and Methamphetamine
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of California, Los Angeles
Collaborators:
MediciNova National Institute on Drug Abuse (NIDA)