|Joie Bednarik, left, research coordinator, pulmonary and critical care section talks with Mike Demuth about some of the information researchers will record during the study. Demuth is UNMC's first nicotine vaccine study participant.|
"I value my health a lot and consider myself an intelligent person but this little stick has so much control over me," he said.
One of about 20.2 percent of adults in Nebraska who smoke, Demuth considers himself an average smoker, but he is concerned about his health, as well as the social side effects of smoking. "It's becoming very much a non-smoking society," he said. "I want to stop smoking and I hope the vaccine helps me quit."
New hope in vaccine
Recently, Demuth, 35, received new hope of beating his powerful urge to smoke when he heard a radio advertisement about a national stop-smoking study at UNMC. He's now become UNMC's first study participant.
UNMC researchers are enrolling 21 patients, age 19 and older, for a nine-month, phase II clinical trial, to evaluate the effects of NicVAX, a vaccine developed by Nabi Biopharmaceuticals for the prevention and treatment of nicotine addiction. Neither researchers nor study participants will know who gets the drug or the placebo.
Several other clinical trials are going on across the country involving various kinds of nicotine vaccines.
|Stephen Rennard, M.D., Larson Professor of Medicine, is principal investigator of the study.|
Exploring a new stop-smoking approach
It's hoped the vaccine will block the pleasurable effects of smoking and if successful, ultimately prevent smokers from starting back smoking. 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, there's no medicine to take and this might work for preventing people from starting back smoking once they've quit. There's nothing right now that we know prevents relapse."
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.
|Part of the research team includes, from left to right: Deborah Sumnick, Dave Daughton and Joie Bednarik.|
Battling nicotine addiction
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. "It's 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.
NicVAX in animal studies
In animal studies, NicVAX appeared to prevent 65 percent of nicotine from reaching the brain, said Dave Daughton, a UNMC pulmonary medicine researcher who has seen about 1,500 smokers in his 25 years of UNMC smoking cessation studies. "We don't know whether that two-thirds is sufficient enough to take the pleasure out of smoking. We really don't 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.
Participants in the study
Those who qualify for the study will make several initial visits followed by weekly 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 chosen to participate in study
UNMC was chosen to be involved in the study because of its relationship with other company studies and because the University of Minnesota recommended UNMC's involvement, said Roxanne Akhavian, senior clinical research associate of Nabi Biopharmaceuticals, which is funding the study backed in part by the National Institute on Drug Abuse.
"We've heard great things about the medical center," Akhavian said. "It was an easy choice."
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 one of the most published researchers in the world of smoking cessation.
Research team members
Other members of the UNMC research team are: Joie Bednarik, clinical research coordinator; Deborah Sumnick, phlebotomy technician and assistant coordinator, and nurse practitioners Mary Carlson and Kim Matthews.
For more information
For more information about the study, call 559-9168.