"Preclinical studies have shown that MN-166 may prevent the activation of certain cells in the central nervous system, called glial cells, that have been linked to drug dependence. We are very excited to move this promising molecule into a Phase 2 clinical trial in partnership with MediciNova and NIDA," said UCLA's Keith Heinzerling, M.D., Assistant Professor, UCLA Department of Family Medicine, Medical Director, UCLA Center for Behavioral and Addiction Medicine, and principle investigator of the trial. "This study has real public health relevance because a medication treatment may improve health outcomes and reduce the public health burden of methamphetamine dependency, especially those with HIV infection, where there is high risk of co-morbidity."
"We are excited to collaborate with the expertise of NIDA and UCLA in studying the potential of MN-166 for methamphetamine addiction," said Dr. Yuichi Iwaki, President and CEO of MediciNova. "Along with our lead clinical program, MN-221 for acute exacerbation of asthma, the broad potential of MN-166 for drug addiction, progressive multiple sclerosis, and neuropathic pain represents a core focus of our development efforts."
About the Trial
The Phase 2 trial will study the safety and efficacy of MN-166 (ibudilast) for the treatment of methamphetamine dependence in treatment-seeking volunteers (N = 140) who will be randomly assigned 1:1 to MN-166 at a dose of 100 mg/day or matching placebo. Half of the trial participants in each treatment group will have a co-diagnosis of HIV as methamphetamine addiction in HIV-positive individuals is a growing issue. During the 12-week outpatient study, dependent subjects will participate in thrice-weekly clinic visits for health checkups, counseling, urine drug screens, and medication adherence monitoring. The study is powered to detect a statistically significant benefit of MN-166 over placebo on the primary study outcome of methamphetamine abstinence during the final two weeks of treatment – an outcome favored by regulatory authorities for addiction medication assessment. Additional endpoints include the effect of ibudilast on methamphetamine use and neurocognitive performance as well as regulation of HIV-associated factors such as T-cell counts and sexual behavior.
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