When Glick came up with the idea to play a Miles Davis song to rats on cocaine, he wasn’t really considering how ridiculous it might look to the rest of the world. He simply wanted to test whether 18-MC could effectively block cravings for cocaine. And, although he is a jazz fanatic with pictures of Louis Armstrong decorating his office, he claims the choice of the song “Four” had nothing to do with his — or the rats’ — taste in music.

“The reason I chose that song is it has a very limited range of pitches,” Glick explains. “It’s very recognizable and it’s very repetitive. It doesn’t vary enough so that it arouses the juices. It’s almost monotonous.”

Glick published his findings from the study in 2012, and the results are both impressive and intriguing for what they reveal about 18-MC’s apparent power to make cravings vanish. Glick concluded that 18-MC “blocked cue-induced reinstatement,” which means the addicted rats no longer had any interest in getting high, even when they heard the Miles Davis song. He also speculated that nicotinic receptors — the parts of the brain impacted by his drug — “may be involved in the mechanism of craving, and that 18-MC may help prevent relapse to drug addiction in humans.”

In July, after a lengthy back-and-forth with the FDA, Hurst convinced the agency to lift the “clinical hold” on 18-MC, clearing the way for human trials to eventually begin in the United States. At the same time, a separate round of trials are already underway in Brazil, where 18-MC holds appeal not only as an addiction treatment but also for leishmaniasis, a nasty parasitic disease that is common in tropical climates. By pure coincidence, 18-MC shows promise as a treatment for both maladies.

The upshot of 18-MC’s dual purpose is that leishmaniasis potentially qualifies as an orphan disease under FDA regulations. That means 18-MC might be eligible for the same tax breaks and fast-track status that led to the blockbuster success of heroin treatment Suboxone.

In a Sept. 23 press release, Savant announced the preliminary results of the first “double-blind, placebo-controlled human safety study” of 18-MC. The drug was reportedly “well tolerated by healthy volunteers.” Hurst noted that 18-MC appears to have none of the harmful side effects of ibogaine, and said a peer-reviewed academic article with additional details is forthcoming.

Even if 18-MC ultimately proves ineffective, Hurst says the company can still fall back on the dozens of related compounds created years ago by Glick and Kuehne. From a business perspective, Savant might not have that kind of time. Rival companies are developing similar drugs that work on nicotinic receptors, and a Florida group is in the advanced stages of testing an anti-opiate drug that uses noribogaine — a naturally occurring metabolite of ibogaine — as the key component.

Yet as of right now, no major pharmaceutical companies are interested in developing 18-MC. The problem is apparently not with the safety of the drug. At NIDA, Montoya says “all the preclinical studies that have been done so far seemed to indicate [18-MC] is safe to be administered to humans,” and, “if there are problems, they will be tolerable side effects — it will not be lethal side effects.”

The risks, rather, are regulatory and financial. Even if 18-MC helps a significant percentage of patients reduce their cocaine intake dramatically during a clinical trial, it’s still possible that the FDA would refuse to make the drug available in the United States. The agency mandates that anti-addiction drugs result in nothing short of an addict becoming completely abstinent. Companies are naturally reluctant to wager millions of dollars in development costs on the long odds that virtually every addict who uses 18-MC will stay clean.

Walsh, the FDA spokeswoman, responded to questions about the agency’s abstinence standard by sending a commentary on anti-addiction drugs authored by FDA officials and published in 2012 in an academic journal. The gist of the article is that clinical studies on hard-drug addiction should be treated like studies on alcoholism, where six months of no drinking is the gold standard for success.

In March, Sen. Ed Markey, whose home state of Massachusetts has been plagued by heroin and painkiller addiction, issued a joint statement with 37 other members of Congress imploring the FDA to create “a larger, faster and more predictable pipeline for the approval of new and promising drugs.” Markey followed up with a sternly worded letter to FDA Commissioner Margaret Hamburg demanding answers about the abstinence standard and the state of anti-addiction research.

“I am concerned that even a perceived focus by FDA on treatments that only result in full cessation of drug use (abstinence) limits the engagement of developers/industry on a broader portfolio of treatment options,” Markey wrote.

Walsh declined to comment on the correspondence, and said the FDA “will review the letter and respond to Senator Markey directly.” Five months later, the FDA replied to Markey's letter, suggesting that labeling could eventually be used to warn that anti-addiction drugs might not be 100% effective in all cases.

"A better relationship between patterns of drug use, short of abstinence, and their clinical benefits, would allow us to identify treatments that are effective in helping patients, even if complete abstinence is not achieved," the FDA wrote. "We need to better understand what patterns of use, if achieved and sustained, translate to clinical benefit, and so serve as a surrogate for the clinical benefit."

While lawmakers and scientists deal with the red tape, cocaine addiction continues to cause significant public health and crime problems. Roughly 34% of federal prisoners locked up on drug charges were sentenced for cocaine or crack, and cocaine is involved in over a third of illicit drug-related emergency room visits.

Experts emphasize that drugs alone probably aren’t going to cure somebody with a serious addiction. The problem runs deeper than just brain chemistry, involving ingrained habits and lifestyle choices.

“In the end, what you want to change is human behavior,” Rotrosen says. “And it’s not necessarily as easy to change somebody's behavior around cocaine as it is overeating or lack of exercise.”

Glick and Hurst are quick to acknowledge that, even in a best-case scenario, 18-MC isn’t likely to be a panacea. It would likely have to be administered over the course of weeks or months along with conventional rehab. But before that happens, it has to earn the FDA’s stamp of approval. And, though the outlook is positive, Hurst cautions there’s still a long way to go before 18-MC is deemed safe and effective enough for American addicts.

“I tell people it’s sort of like a journey through the Himalayas,” Hurst says of the drug development process. “You reach the top of the mountain in front of you, and you look out and see another mountain range you have to climb over. We’ve gotten up over the first mountain range. There’s at least another one beyond that.”