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CENTURY
Yale University
School of Medicine
SAC-203
Connecticut
Mental Health Center
34 Park Street
New Haven, CT 06519

Phone:
203-974-7591

Fax:
203-974-7606

E-mail:
infocentury@yale.edu

News

CENTURY/TTURC Abstract
From Selegiline for Smoking Cessation pilot project

A Preliminary Placebo-Controlled Trial of Selegiline Hydrochloride for Smoking Cessation

Biological Psychiatry 2003;53:136-143

Tony P. George, Jennifer C. Vessicchio, Angelo Termine, Peter I. Jatlow,
Thomas R. Kosten, and Stephanie S. O'Malley

Note: This study received coverage in the Los Angeles Times and on WebMD in January and February 2003. See below for copies of articles.

Background: Since dopaminergic mechanisms appear to be involved in nicotine dependence, we studied the safety and efficacy of the monoamine oxidase B inhibitor selegiline hydrochloride compared with placebo for smoking cessation in nicotine-dependent cigarette smokers. Methods: Forty subjects with DSM-IV nicotine dependence
were randomized to: 1) selegiline hydrochloride (5 mg p.o. twice daily) or 2) placebo in an 8-week trial. Outcome measures included smoking cessation rates, treatment retention, and medication side effects.

Results: Selegiline hydrochloride increased trial end point (week 8) 7-day point prevalence smoking cessation rates (selegiline hydrochloride, 9/20 [45.0%]; placebo, 3/20 [15.0%], odds ratio _ 4.64, 95% CI, 1.02-21.00, p _ .05), and smoking cessation rates during the last 4 weeks of the trial (selegiline hydrochloride, 6/20 [30.0%]; placebo, 1/20 [5.0%], odds ratio _ 8.14, 95% CI, 0.88-75.48, p _ .07) in comparison with placebo. Six-month follow-up 7-day pointprevalence smoking cessation rates were reduced comparedwith trial end point (selegiline hydrochloride, 4/20 [20.0%]; placebo, 1/20 [5.0%], odds ratio _ 4.75, 95% CI, 0.48-46.91, p _ .18). Treatment retention was similar between drug and placebo groups (p _ .13), and selegiline hydrochloride was well tolerated in cigarette smokers.

Conclusions: This preliminary study suggests that selegiline (10 mg/day) is safe for use and enhances smoking cessation rates compared with placebo in nicotine-dependent
cigarette smokers. Biol Psychiatry 2003;53: 136-143 © 2003 Society of Biological Psychiatry

The Los Angeles Times, Feb. 10, 2003

Parkinson's drug may help smokers who want to quit
By Dianne Partie Lange

People who have repeatedly tried to stop smoking may get a break from the addiction with a drug often used to treat Parkinson's disease.

As part of a Yale University study, 20 smokers were given selegiline hydrochloride (L-Deprenyl or Eldepryl) and 20 were given a placebo; both groups attended weekly counseling. After eight weeks, 45% of smokers had quit, but only 15% of those taking a placebo did so.

Because people addicted to drugs or cigarettes may have lower than normal levels of the neurotransmitter dopamine, which leads to drug cravings and use, keeping the dopamine levels up may prevent cravings when the smoker quits, explains the lead author of the study, Tony P. George, assistant professor of psychiatry at Yale University Medical School. Selegiline inhibits the enzyme monoamine oxidase B (MAO-B), that normally breaks down dopamine, keeping dopamine levels from falling. Although other investigators have evaluated MAO-B inhibitors in smokers, this is the first published study to test the drug's effects on quitting smoking.

The study was published in the Jan. 15 issue of Biological Psychiatry.

WebMD, Jan. 24, 2003

Original article: http://my.webmd.com/content/Article/59/66872.htm

Parkinson's Drug May Help Smokers Quit

By Sid Kirchheimer
WebMD Medical News
Reviewed By Brunilda Nazario, MD on Friday, January 24, 2003

Jan. 24, 2003 -- A drug used to treat Parkinson's disease may someday join patches, gums, and lozenges in helping smokers to quit. But unlike those products that actually supply nicotine in a less
health-harming way, Eldepryl is believed to work by mimicking the effects of smoking in boosting levels of the "pleasure-enhancing" brain chemical dopamine.

Eldepryl is used in conjunction with levodopa to treat Parkinson's disease, caused by a deficiency of dopamine. Eldepryl blocks the breakdown of dopamine so it stays in the system longer.

The act of smoking causes an immediate release of dopamine, which in recent years has emerged as playing an integral role in many addictive behaviors. Nicotine and other components in tobacco
"fool" parts of the brain to release dopamine, creating a sense of well-being and satisfying cravings. But the brain soon develops a need for more dopamine, creating stronger and more frequent
cravings and as a result, an addiction.

But Yale researchers report in the Jan. 15 issue of Biological Psychiatry that treating hard-core smokers with Eldepryl not only helped curb their cravings, it enabled them to remain smoke-free for at
least one month -- the government's measure of quitting -- at a rate six times better than a placebo. Each of the 40 smokers studied had tried to quit several times before with no success.

"One of the problems with the nicotine replacement products like gums and patches is that many smokers don't respond to them, so there is clearly a need for other drugs to help people quit," says study author Tony George, MD, assistant professor of psychiatry at Yale University School of Medicine. "The nice thing about this drug is that it seems effective, and it was very well-tolerated by patients, causing very few and minor side effects."

In his study, six of the 20 smokers receiving Eldepryl remained smoke-free for the last month of the eight-week trial, compared with only one of 20 others getting a dummy pill. By the last week of the trial, nine smokers taking Eldepryl remained smoke free while only three who got the dummy pill did.

This success rate is close to that of Zyban, a smoking-cessation drug that also raises dopamine levels. Like Zyban, an advantage of Eldepryl is that it doesn't supply the body with nicotine in another form, which would cause an increase in heart rate.

Although some of the drugs that block dopamine breakdown can raise blood pressure, Eldepryl does not. "So an advantage to this drug -- at least taken at the dose that proved effective in our study -- is that it won't raise blood pressure," George tells WebMD.

Though his study is believed to be the first to actually test the effectiveness of Eldepryl as a smoking-cessation aid, previous studies have showed the drug to be effective in reducing cravings for cigarettes -- including one by Johns Hopkins researchers that was published in Psychopharmacology last September.

"What we did was have patients abstain from smoking for two days and then measured their withdrawal symptoms -- particularly cravings," Hopkins researcher Elisabeth J. Houtsmuller, PhD, tells WebMD. "We found that those treated with (Eldepryl) not only had fewer cravings, but when they did smoke, before and especially after abstinence, they rated their cigarettes as less pleasant and they smoked fewer of them."