The Food and Drug Administration (FDA) has expedited the testing of Ibudilast into its second phase of testing out of three clinical trials. Ibudilast, if results are favorable, may become the first real cure for methamphetamine addiction.
“Very preliminary results would indicate that Ibudilast may dampen craving and improve cognitive functioning,” said Dr. Aimee Swanson, co-investigator on the trial and research director at the UCLA Center for Behavioral and Addiction Medicine.
The approval of the second phase of testing, which will be funded by the National Institute on Drug Abuse, comes at the heels of the positive outcome of the first trial on meth-dependent participants in an outpatient situation.
During the first clinical trial, UCLA Center for Behavioral and Addiction Medicine researchers administered Ibudilast to 11 subjects who were addicted to methamphetamine. The 11 volunteers were paid and were not necessarily seeking meth-addiction treatment. Upon completion of the trial, the UCLA researchers deemed Ibudilast was safe, prompting the FDA to fast track it until its second phase of clinical trial testing.
Typically, the FDA uses the “fast track” process to accelerate the review of a drug needed for a serious disease in order to get the new medication to sick patients faster.
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Ibudilast, also known as MN-166, has been marketed for nearly 20 years for treating asthma in Japan as a phosphodiesterase inhibitor. As of late, the drug has been determined to have anti-inflammatory properties for both the central nervous system and the immune system. The anti-inflammatory properties directed toward the central nervous system have the potential to treat various central nervous system disorders, including neuropathy, multiple sclerosis, in addition to improving the safety of opioids by reducing withdrawal and tolerance.
Currently, Ibudilast is licensed to MediciNova for the treatment of multiple sclerosis in other parts of the world but is not yet approved in the United States. MediciNova is the only U.S. company currently with rights to Ibudilast.
Second Ibudilast Clinical Trial
Set to begin this summer, the second trial will include more volunteers. Up from 11 in the first trial, the second trial will include 140 volunteers. The trial will last 3 months. Half of the participants will take a placebo, while the other half will take Ibudilast.
According to the National Institute on Drug Abuse, in the neighborhood of an estimated 13 million people ages 12 years or older have abused meth at least once in their lifetime. In 2010, more than 350,000 people were using meth, the institute reports. Certain areas of the country show more abuse inclinations including:
- The Midwest
- The West Coast
How Methamphetamine Works
By increasing the levels of dopamine in the brain, methamphetamine provides its user with a feeling of euphoria. However, once this pleasure “surge” is over, the user experiences a “crash”. Both the surge of pleasure and crash prompt repeated use of meth. Eventually, though, tolerance builds and the user isn’t able to achieve pleasure from natural sources.
In addition to addiction, long-term use of meth results in a number of detrimental psychiatric and physical effects, including:
- Violent, destructive behavior
- Hallucinations and delusions
- Cardiovascular difficulties (fast-paced or irregular heartbeat, elevated blood pressure)
Current Meth Addiction and Abuse Options
While Ibudilast may look promising, in reality, it’s going to take years to get here. The results of this summer’s 12-week trial aren’t expected to be released until early 2015, said the UCLA researchers. Even then, if the results of the second clinical trial are positive, another third, larger study, will be conducted. If all goes well in the second and third clinical trials, it’s possible that the FDA will approve Ibudilast by 2018.
Still, other meth treatment options currently exist. Both outpatient and inpatient rehabilitation offer cognitive therapies, counseling, and a supervised detox process to help the methamphetamine abuser recover. Narcotics Anonymous and Crystal Meth Anonymous are other considerations for those who desire to quit using it.
Methamphetamine’s strong addiction pull coupled with its destructive health consequences make its abuse especially alarming. The good tolerability of Ibudilast and its positive initial clinical trial make it a promising potential recourse where the help is sorely needed.