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.