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Drug That Cured Rats of Addiction Begins Human Trials

Human trials are about to get underway on a unique new treatment for drug addiction, obesity and other forms of compulsive behavior.

Savant HWP, a privately held company in San Carlos, California,  has received a $6.5 million, three-year grant from the National Institute on Drug Abuse to support the development of 18-MC (18-methoxycoronaridine) as a treatment for addiction. This year, Savant will be starting clinical trials in Brazil. It hopes to expand the human trials to the United States in 2014.

"Unlike current treatments for drug addiction and nicotine abuse, 18-MC uniquely targets the central dopamine ‘reward’ pathway involved in all forms of addictive, pleasure-seeking  behaviors, including over-eating," said Stephen L. Hurst, Savant HWP chairman and chief executive officer.

The drug was first synthesized in 1996, starting with a naturally occurring compound called ibogaine, an extract of the bark of the root of the African iboga shrub. For hundreds of years, the roots of this shrub have been used by people in the Bwiti tribe for ceremonial purposes and to stay awake when hunting. Ibogaine is a psychoactive substance and its potential usefulness in treating addiction, and even overeating, was first recognized in the 1800s. Because it is psychoactive, ibogaine has been outlawed in many countries. As a result, scientific research into its useful properties has been slow.

In 1996, pharmacology researcher Stanley D. Glick and his team from Albany Medical College and the University of Vermont synthesized 18-MC from ibogaine and tested it in drug-addicted lab animals. The  rats in the study were allowed to administer common addictive substances such as cocaine, morphine, nicotine and methamphetamine to themselves for a period of time each day. The animals happily took the drugs whenever given the chance to do so, indicating addiction.

The team had success getting the addicted rats to lessen their use of the substances by administering 18-MC. Just one dose lessens withdrawal symptoms and the intense cravings that lead addicts to use time and again.

"18-MC is likely to be the first of a new generation of agents effective against a broad spectrum of addictions—from hard drugs such as heroin and cocaine, to alcohol, nicotine and even sugary, high-fat foods, possibly reducing obesity rates," said Glick, who has studied the neurobiology of addiction for 40 years.

Ibogaine has been used in humans to reduce cravings, with success, but with complications as well. The administration of the compound to humans occurred in the 1960s in the Netherlands, and while several addicts stopped using as a result, one died. Other studies indicated that high levels of ibogaine could cause brain damage in rats.

The creation of the derivative 18-MC represents a new and important step in using this natural compound, ibogaine, to help addicts. In the rat trials, it seems to lack the dangerous side effects possible when ibogaine is used. The researchers believe that 18-MC acts on a secondary reward pathway in the brain, dampening the primary pathway.  The difference between 18-MC and ibogaine, and the reason that the latter causes side effects, is that ibogaine acts on several receptors in the brain, while 18-MC acts on just one.

In spite of the overwhelming evidence that 18-MC could be a positive new medication for the treatment of addiction, with no known side effects, funding to do human clinical trials has been difficult to get. When the National Institute on Drug Abuse voted to ban ibogaine research, the work with 18-MC was tarnished by association. Glick and his team, working with 18-MC in rats, have tried for years to get the funding for further work.

Finally, the hard work and persistence have paid off and Glick, the scientific founder of Savant, has his money for 18-MC clinical trials. In addition to treating drug addicts, Glick hopes that 18-MC will help reduce obesity rates by keeping overeaters from craving sugar and fat. A seemingly unrelated condition, leishmaniasis, which causes painful lesions on the skin and damage to internal organs, may also be treatable with 18-MC.

Posted on March 26th, 2013

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