UNMC researchers involved in national study to evaluate nicotine vaccine; new approach gives smokers new hope to quit, stay quitting

Mike Demuth, 35, has had enough of his 15 years of addiction to cigarettes.

Hes tried just about everything to quit. I value my health a lot and

consider myself an intelligent person, but this little stick has so much

control over me.

Demuth is participating in a University of Nebraska Medical Center clinical

study on NicVAX, a vaccine developed by Nabi Biopharmaceuticals for the

prevention and treatment of nicotine addiction. Neither researchers nor

study participants will know who will get the drug or the placebo.

One of about 20.2 percent of adults in Nebraska who smoke, Demuth considers

himself an average smoker. He said not only is he concerned about his health,

but also the social side effects of smoking. Its becoming very much a

non-smoking society. I want to stop smoking and I hope the vaccine helps

me quit, he said.

UNMC researchers are enrolling 21 patients, age 19 and older, for a

nine-month, phase II clinical trial, to evaluate the effects of NicVAX.

UNMC, the University of Wisconsin Medical School and the University of

Minnesota are involved in the Nabi study.

Like vaccines that prevent disease, the nicotine vaccine generates antibodies

in the body that attach to nicotine molecules, making them larger and more

difficult to get into the brain. It is thought the vaccine blocks the pleasurable

effects of smoking and if it proves successful, ultimately may prevent

smokers from starting back once theyve quit. Most people have tried to

quit smoking at least once. Of those who quit, most go back to smoking

within a year.

The vaccine is a completely new approach, said Stephen Rennard, M.D.,

Larson Professor of Medicine, UNMC Pulmonary and Critical Care Section

and principal investigator of the UNMC study. With a vaccine, theres

no medicine to take and this might work for preventing people from starting

back smoking once theyve quit. Theres nothing right now that we know

prevents relapse.

Theres a huge need for new stop-smoking products, Dr. Rennard said.

The ones we have now only work 30 percent of the time for very highly

motivated people.

Nicotine is a potent psychological compound, as potent as cocaine and

heroin, according to the National Institute on Drug Abuse. Like cocaine

and heroin, nicotine stimulates the release of a chemical called dopamine,

located in parts of the brain that are involved in addictive behaviors.

Cigarette smoking is associated with an estimated 430,000 deaths a year.

It takes a long time to become addicted to cigarettes, Dr. Rennard

said. Its a slow process that may take 10 years. After quitting, all

it takes is one cigarette in a moment of weakness and invariably a couple

of weeks later, the person will be smoking again. Most smokers have tried

to quit.

UNMC researchers say the estimates of relapse within a year after quitting

smoking is 95 percent for those who quit cold turkey and 80 percent for

those who use some type of stop-smoking product.

In animal studies, NicVAX appeared to prevent 65 percent of nicotine

from reaching the brain, said Dave Daughton, a UNMC pulmonary medicine

researcher whos seen about 1,500 smokers in his 25 years of UNMC smoking

cessation studies. We dont know whether that two-thirds is sufficient

enough to take the pleasure out of smoking. We really dont know how well

people will respond to this vaccine.

He said study participants also have the ability to use other smoking

cessation aides during the trial.

Those who qualify for the study will make several initial visits followed

by once a week visits for about nine months. During the study, researchers

will gather a variety of information, including the level of antibodies

in the body, as well as immune response, changes in smoking habits and

side effects. Results should be known in about a year. Study participants

will use hand-held personal computers to record a diary of questions which

will be sent daily to researchers.

UNMC has been involved in many national studies involving stop-smoking

products currently on the market, including the nicotine patches, nicotine

gum and Zyban, a pill that decreases the craving to smoke and has some

anti-depression effects. Dr. Rennard has written about 100 articles, and

is considered one of the most published researchers in the world of smoking

cessation.

For more information about the study, call (402) 559-9168.