Quitters get a shot in the arm


Steve Ballou, an ex-smoker for more than a decade, started slipping back into his old ways with cigars. He'd have one when he was out with the guys, then when he was driving home from work, then one after dinner.

This went on for several years, but he thought of himself as a cigar aficionado, not a relapsed smoker, since cigarettes were never on the menu.

Until he vacationed in the City of Lights.

Ballou will forever associate Paris' nickname with the act of lighting a cigarette. Over lunch one day, he realized he'd forgotten to buy a cigar to savor after the meal. So he bummed a cigarette from his wife, an occasional smoker. "I smoked half her pack that afternoon, and from that point on, I was a smoker," says Ballou, 54, a Sherborn, Mass., resident who works in financial services.

He had a smoker's typical love/hate relationship with cigarettes. "I really did want to quit, but I was a nicotine addict. I needed something to help me get over this."

That something was a nicotine vaccine.

Researchers are investigating whether the same approach used to prevent infectious diseases could treat addictions to such drugs as nicotine and cocaine.

None is yet on the market, but in late September, the National Institute on Drug Abuse (NIDA) released a $10 million stimulus grant to Nabi Pharmaceuticals to help pay for the first Phase III trial -- a large study designed to confirm effectiveness and monitor side effects -- of a smoking-cessation vaccine. Company spokesman Greg Fries says Nabi, based in Rockville, Md., expects to begin enrolling patients in the NicVax study by year's end.

In early October in the Archives of General Psychiatry, scientists reported the results of a cocaine vaccine study, the first successful placebo-controlled trial of a vaccine against an illicit drug of abuse. At a news conference, NIDA director Nora Volkow, whose institute funded the study, called the findings "transformative."

Wary of cocaine vaccine

Kim Janda, who has been studying vaccines to treat addiction since the late 1980s, predicts one against nicotine will hit the market within two years. "I think you can make antibodies to any drug of abuse," adds Janda, a chemistry professor at the Scripps Research Institute in La Jolla, Calif.

But, says Thomas Kosten, leader of the recently published Archives study, no company is interested in developing a cocaine vaccine because of liability concerns and the assumption it wouldn't be nearly as profitable as a nicotine vaccine.

Nicotine and cocaine molecules are so tiny that they easily pass from the bloodstream into the brain, where they produce feelings of pleasure or euphoria. This is where the vaccines come in. Like those against infectious diseases, the nicotine and cocaine vaccines stimulate the immune system to produce antibodies. These antibodies bind with the molecules, and the combo is far too large to pass through the blood/brain barrier.

Quitters must commit

Ballou joined the phase II NicVax trial at Boston's Massachusetts General Hospital after seeing an ad seeking volunteers. He was to receive one shot a month for five months and was asked to try to quit smoking after the second shot.

As in most clinical trials, Ballou was not told whether he was getting the real thing or a placebo. But, he says, after the first shot, "I knew instantly that I was not getting the placebo. I was overjoyed." How could he tell? After that first shot, cigarettes no longer tasted good. Instead of pleasure, smoking gave him a headache and burned his throat. Between the first two shots, "I found myself smoking less and less."

He last smoked three years ago. "I can honestly tell you the vaccine was truly the thing that gave me that extra push I needed to get over the top."

Half the volunteers in that study achieved satisfactory levels of nicotine antibodies, Nabi says. A second study added a sixth shot and raised that proportion to 80%.

The company says it's optimistic nicotine antibodies will persist long enough to prevent a relapse, which happens within a year of quitting in most cases. Getting ex-smokers through six smoke-free months would greatly reduce their relapse risk, says psychologist Douglas Jorenby of the University of Wisconsin's Center for Tobacco Research and Intervention in Madison, which is testing NicVax.

Addiction vaccines are an aid, not a cure, Janda says, and the need for multiple shots might dissuade the less-committed. "Too many doses are required," he says. "Most people who read about it think it's like a polio vaccine. They think it's a one-shot deal and you're covered for life."

The cocaine vaccine study also used five shots. Virtually everyone got all five, but only 38% reached antibody levels thought to be high enough to block cocaine's euphoric effects. "It's not ready for prime time yet," Kosten says. Urine tests showed some tried to override the vaccine by using more cocaine, he says.

That points out a risk in giving a nicotine vaccine to teens, who could try to defeat it by smoking 10 cigarettes at once, Kosten says. They might get some of nicotine's effect, but they'd also be getting 10 times the carcinogens found in one cigarette.

Still, Janda says, addiction vaccines hold great potential: "You're not treating a drug problem with another drug. It's much more palatable to take advantage of our immune system, the best foot soldiers around."

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