The Food and Drug Administration's quick approval for second phase testing of methamphetamine addiction has promising outcomes. Ibudilast, if proven effective, could become the first cure for meth addiction.

This is the first trial to collect information on meth-dependent subjects in an outpatient environment.

"There are many people who are struggling with methamphetamine addiction and currently no proven effective medication," said Keith Heinzerling, assistant clinical professor at the University of California Los Angeles' Center for Behavioral and Addiction Medicine.

"There are two sides to the coin in the real world: trying to get evidence whether meds help and getting it approved," Heinzerling said. "If medication is working and not approved there are no means to have access to it."

For the first of three trials, UCLA researchers administered Ibudilast, also referred to as MN-166, to 11 meth addicts. When they determined Ibudilast was safe, the FDA approved to fast-track the research into its second phase.

A fast track status is rare. According to the FDA, fast tracking is used to quicken the review of drugs for serious diseases in an effort to get new drugs faster to patients.

From the ethical perspective, giving participants significantly low doses of meth between 15 and 30 mg in the hospital was much safer than what was taken in their normal environment, where the best estimated measure is upwards of 200 mg or 500mg, Heinzerling said.

The researchers looked for participants who were not intending to quit. This assured them that they could get an accurate model of drug response for a meth-dependent individual. In addition, the trials made sure the participants were not referred to counseling or support groups

The second trial, which will include 140 volunteers, is set to start in the summer for a period of 12 weeks. Half of the participants would take Ibudilast while the other half take a placebo twice a day.

"If it reaches approval status and there's big changes and insurance companies realized this, and they can provide return in investment by helping them quit drugs and less utilizations of resources," Heinzerling added.

In a 2005 study, experts estimated the imposed cost of methamphetamine addiction to society was $23.4 billion and the National Institute on Drug Abuse found that nearly 13 million Americans ages 12 and older have abused meth once in their lifetime, out of which 353,000 are currently dependent

According to pharmacology experts, Ibudilast was marketed in Japan for more than 20 years to treat patients with asthma and its anti-inflammatory reactions interested researchers to test its effect on the immune and central nervous systems. Meth addicts taking the drug have shown improvement in decreasing opioid dependence and tolerability.

Ibudilast is currently licensed to MediciNova for treating multiple sclerosis but the company is not approved to sell in the United States. Last week, the American biopharmaceutical company announced their interest in curbing opioid and heroin addiction through the drug's ability to induce opioid withdraw symptoms. They joined the National Institute on Drug Abuse in 2005 to review the drug's effect on mice and monkeys addicted to meth.