Modafinil May Be Addictive

NIDA study casts doubt on safety of “brain booster” drug.

Despite the headlines, most new drugs are not addictive. Very few medications show the distinctive side effects associated with clinical drug addiction: tolerance, withdrawal, and continued use despite adverse consequences. Such drugs are relatively rare—so it was with interest and alarm that addiction specialists confronted a small pilot study, led by Dr. Nora Volkow of the National Institute on Drug Abuse (NIDA), which appeared to demonstrate that the sleep drug modafinil has addictive potential.

Modafinil, sold as Provigil, has found increasing off-prescription use for the treatment of ADHD and other psychiatric disorders. The drug is also being used as a so-called “cognitive enhancement” drug or “brain booster,” particularly among college students and military field personnel. Modafinil had even shown early promise as a drug for the treatment of cocaine addiction.

In the March 18 issue of the Journal of the American Medical Association (JAMA) , the researchers reported on levels of extracellular dopamine in the brains of 10 healthy men on either placebo or modafinil.

According to the researchers, “Modafinil acutely increased dopamine levels and blocked dopamine transporters in the human brain. Because drugs that increase dopamine have the potential for abuse, and considering the increasing use of modafinil for multiple purposes, these results suggest that risk for addiction in vulnerable persons merits heightened awareness.”

Scientists were initially excited about a drug which showed stimulant properties but did not appear to have a direct effect on the dopamine pleasure systems of the brain—a finding that set it apart from drugs like amphetamine and cocaine. However, as reported online by Heidi Ledford of Nature, “Animal studies showed that rodents that lack dopamine receptors are unresponsive to the drug, and in 2006, researchers found that modafinil affects dopamine levels in the brains of rhesus macaques.”

Dr. Volkow stressed that patients taking modafinil for recognized medical conditions such as narcolepsy should continue to do so, while doctors should monitor modafinil patients for signs of dependency.

Still, dopamine is not all there is to addiction. As reported in Nature, Bertha Madras of Harvard Medical School notes that some drugs that boost dopamine have other properties that make them aversive, and therefore not addictive. “The full spectrum of the pharmacology of the drug is what drives the abuse potential,” she said.

[The following added 8.00 pm 3-18-09]: In addition, Corpus Callosum has an excellent in-depth look at why the results of the study should be interpreted conservatively.]

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Utah Legislator Calls for Tax on Coffee

States look to addictions as a revenue stream.

Are caffeine revenue streams the next big thing, or a bright idea whose time will never come? Will we see the staging of a Boston (make that Salt Lake City) Coffee Party by disgruntled, under-caffeinated voters, if the state of Utah has its way?

We do it with tobacco products. We do it with alcoholic beverages. We slap a hefty extra “sin tax” on addictive but legal products as an easy source of revenue. Times are tough. State revenue streams have dried up. But coffee? Caffeinated soft drinks?

Taxing caffeine would be “like taxing candy,” according to one Utah resident, reacting to a state legislator’s call for a tax on caffeine products. The legislator in question, Republican state representative Craig Frank, suggested the measure after efforts to raise cigarette taxes in the state failed. The initial proposal centered on “cold caffeine” such as canned sodas, but was quickly broadened to include coffee and other caffeine products

Frank told the Salt Lake City Tribune in an article by Robert Gehrke that if the state was intent on “going after people who have problems with addiction for a revenue stream,” a tax on caffeine would be more broad-based than existing “sin taxes” on alcohol and cigarettes—two other highly addictive but legal substances. The government itself, said Frank, is “addicted to the fee revenues. So in light of that... why not cold caffeine?” Ultimately, why not caffeine, period? Frank pointed out that caffeine, like alcohol and nicotine products, has been linked to health problem, such as spontaneous abortion.

A recent study by the Rockefeller Institute of Government showed that Utah lost 16.5 per cent in tax revenues in the fourth quarter of 2008. The National average was 3.6 per cent.

In 2003, Seattle voters rejected a similar initiative that would have imposed a 10-cent tax on every cup of espresso-based coffee. Vancouver, B.C., tried and failed to enact a similar measure. Recently a councilperson in Nashville, TN, has also suggested a coffee tax. Last month, California Assemblyman Tom Ammiano proposed to extract substantial state revenue from a sales tax on marijuana.

All of these efforts have met with a significant lack of enthusiasm on the part of the citizenry.

Picture Credit: Worth1000

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Government Kicks Off New Alcohol Web Site

Will NIAAA site help identify problem drinkers?

Alcohol use exists on a spectrum, from occasional sippers to full-blown alcoholics. If you have ever asked yourself where, exactly, on the drinking spectrum your own alcohol use falls, a new government web site aims to help you answer that question.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is making an effort to become more relevant and up-to-date by establishing a flashy new web site based on a revamped institutional philosophy. The idea, writes Melinda Beck of the Wall Street Journal , is to “help people recognize problems patterns earlier and catch themselves before they fall.”

Beck notes that the NIAAA web effort is a result of “a new understanding that there is a spectrum of alcohol-use disorders, which some experts hope will replace the current criteria for ‘abuse’ and ‘dependence.’”

The new site, called “Rethinking Drinking,” is a bit confusing to navigate at first. However, there is actually a wealth of information tucked away on the site. For example, people can compare their alcohol intake with the general population and with problem drinkers. There are “low-risk” drinking recommendations, an explanation of why women become intoxicated on less alcohol than men, and a list of medications that react negatively when combined with alcohol. Web surfers are also given a primer on “standard” drinks—some cocktails are equivalent to three standard drinks, and a bottle of wine counts as five glasses.

In the Wall Street Journal article, Mark Willenbring, NIAAA’s director of treatment and recovery research said that most people “don’t know what ‘drink responsibly’ means—they think it means not getting tanked. But there are levels of drinking that raise your risk for alcohol problems just like high cholesterol raises your risk for heart disease.” Low-risk drinking—no more than four drinks for men and 3 for women at a sitting, and no more than 14 drinkers a week for men and 7 drinks a week for women—can increase the risk of adverse events for people suffering from liver disease, heart arrhythmia, and bipolar disorder.

One little-known fact, according to the web site: Some 35 per cent of Americans don’t drink at all.

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Drug Research and the Recovery Act of 2009

What's in the budget for addiction scientists?

Scientists were among the likely beneficiaries of President Obama’s American Recovery and Reinvestment Act of 2009.

The National Institutes of Health (NIH) is slated to receive $10 billion for use over the next two years. A yet-to-be-determined portion of the grant will end up with the National Institute on Drug Abuse (NIDA).

Here is a sampling of NIDA’s wish, or “Challenge Topics” for which the agency is seeking grant proposals. The application due date is April 27, 2009.

--Dietary treatment of substance disorders.
“There is abundant preclinical and clinical evidence that suggest dietary therapies and behavioral interventions can promote neurogenesis, diminish susceptibility to metabolic and excitotoxic injury (e.g., diets rich in antioxidants), and/or counteract stress responses within the brain. Dietary regimens or supplements can be evaluated as individual treatments or as adjuncts to FDA-approved medications.”

--Drug genetics and informed consent.
“Address ethical issues related to access to broad sharing and use of new genetic information and technologies for addiction research to improve treatment and prevention options for addicts.”

--Addiction drugs combined in treatment.
“Network biological analysis predicts that modification of a single target by a drug is not nearly as likely to affect disease outcome as would rational combinations of drugs that target multiple, complementary mechanisms. Applications will focus on combination of medication strategies for the treatment of substance use disorders.”

--Neurobiology of opioid addiction.
“There is an urgent need for research that will more thoroughly delineate the neurobiological implications of long-term opioid use. This knowledge gap is of particular concern when it comes to the developing brain - and the urgency is underscored by the fact that increasing numbers of adolescents and young adults are using opioid medications, prescribed and otherwise.”

--Research on addiction drugs for pregnant women.
“Substance abuse during pregnancy often occurs in the context of complex environmental factors and poly-drug exposure, as well as medical conditions which are associated with adverse neonatal consequences. Much is known in regard to the negative effects of substances of abuse on the pregnant/post partum women and their substance exposed neonates but relatively little is known in regard to medication treatment strategies and research methodology.”

--Internet-based prevention and treatment in rural locations.
“Many persons living in remote or rural locations have limited opportunities to obtain drug abuse treatment services, due to a lack of available service settings, the barrier of traveling long distances, and/or the perceived lack of private and confidential treatment options. This program seeks to develop web-based drug abuse treatment interventions that do not necessitate frequent in-person visits to a central facility.”

--Finding new molecular targets for addiction treatment drugs.
“Projects may utilize techniques ranging from gene knockout technologies, behavioral evaluations, assay development, and targeted library synthesis and screening that could lead to the development of medications for drug addiction treatment. The focus may be on the identification of new molecular targets, and/or the discovery of small molecule selective ligands for previously identified targets, such as muscarinic M5 antagonists, neuropeptide Y antagonists, and neurotensin agonists.”

For general information on the National Institute on Drug Abuse implementation of NIH Challenge Grants, contact:

Christine Colvis, Ph.D.
NIDA Challenge Grant Program Coordinator
National Institute on Drug Abuse
National Institutes of Health
Phone 301-443-6480
Email ccolvis@nida.nih.gov


Photo Credit:www.ecampusnews.com

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Time for a Sales Tax on Sinsemilla?

Will states let marijuana revenue go up in smoke?

As California State Assembly member Tom Ammiano put it: “What if California could raise hundreds of millions of dollars in new revenue to preserve vital state services without any tax increase?”

That question is likely to hook any state legislature’s attention these days. When times are tough, you go with your strengths. In California, one of those strengths is the nation’s most robust homegrown marijuana industry—virtually all of it off the books at present.

Reeling from a $42 billion budget deficit, the California government has been slashing deeply into state spending. The marijuana industry, variously estimated at anywhere between $4 and $14 billion per year, is the state’s largest cash crop.

Is this any time to be turning down a couple of billion dollars a year in potential state revenue? The question of marijuana decriminalization may begin to be seen under a different light, as cash-strapped states look in every corner for ways to add revenue.

The Marijuana Control, Regulation and Education Act, introduced in the California legislature last week, would legalize the possession and sale of marijuana for people over 21—with a hefty sales tax similar to the taxes imposed on the sale of alcohol and cigarettes. The bill would prohibit open street sales or sales near schools. Marijuana wholesalers would be charged several thousand dollars up front to distribute the crop, and an individual sales fee of $50 per ounce at the retail level would be applied.

Proponents of the bill claimed it would generate more than $1 billion annually, according to a report by Stu Woo in the Wall Street Journal. The California chapter of NORML estimates that the take for the Golden State could be as high as $2.5 billion a year, when excise taxes, savings in law enforcement expenditures, and spinoff industries like coffee houses are taken into account.

Ammiano, the Democrat from San Francisco who introduced the bill, told Salon: “I do have support from a lot of colleagues, who say, ‘Oh my God, I think this is great, but I don’t think I can vote for it.’” In an opinion piece for the San Francisco Chronicle, Ammiano wrote that his reason for introducing the bill was to begin “a rational public policy discussion about how best to regulate the state’s largest cash crop, estimated to be worth roughly $14 billion annually. Placing marijuana under the same regulatory system that now applies to alcohol represents the natural evolution...” In addition, Ammiano suggests, “Regulation allows common-sense controls and takes the marijuana industry out of the hands of unregulated criminals.”

A lobbyist for California police groups told the Wall Street Journal that the bill was “based on a fallacious assumption that if we could only legalize marijuana, that we will have fiscal and social Shangri-La.”

Nonetheless, more than a dozen states have signaled a willingness to move toward more liberal marijuana enforcement policies recently. All of these efforts eventually collide with competing federal statutes, making the possession and sale of marijuana potentially a federal crime. As with the issue of gay marriage, it is possible that states will continue to push back, resisting federal efforts to nullify state changes in marijuana enforcement policy.

Photo Credit: Forest Service Drug Control Program

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Cancer and Women Who Drink: A Flawed Study?

Taking a second look at the numbers.

Last week’s front page Washington Post story on the increased risk of cancer among women who drink shed more heat than light on the underlying conundrum: Are a few drinks good for you, or aren’t they?

A British study involving almost one and a quarter million women—a huge survey by any standards—found that just one drink of alcohol per day increased the statistical risk of contracting cancer. According to the Post story by Rob Stein, as little as 10 grams of alcohol a day elevated women’s risk for cancer of the breast, liver, and rectum in particular. “Based on the findings, the researchers estimated that about 5 percent of all cancers diagnosed in women each year in the United States are the result of low to moderate alcohol consumption,” the Post reported. “Most are breast cancers, with drinking accounting for 11 percent of cases—about 20,000 extra cases each year—the researchers estimated.”

But wait a minute. Wasn’t it just yesterday that researchers were confirming and reconfirming that a couple of drinks a day was good for your heart? Presumably, this included women’s hearts as well. What’s going on?

For starters, the conclusions of the study itself, published in the Journal of the National Cancer Institute, have some problems. In an article entitled, “Women: How Bad is a Regular Nip?” Janet Raloff writes in the Web edition of Science News that female participants were queried only about weekly alcohol consumption. To arrive at figures for daily intake, the researchers divided by seven. “However,” writes Raloff, “if someone averages seven drinks a week, those beverages might have been downed on weekends only—leading to consumption of three or more drinks at a sitting. That would be bad even for the heart. Also, in the long haul, for anyone’s liver.” Unless we know about daily drinking, the study “only offers fodder for speculation.”

There are other problems. As it turns out, nondrinkers have an elevated risk for certain kinds of cancers. Study author Naomi Allen and coworkers at the University of Oxford write that alcohol apparently confers some sort of protective effect when it comes to cancers of the pharynx, esophagus, stomach, cervix, and other sites.

In addition, Raloff, points out, “There’s the impact of smoking.” Some of the alcohol-linked cases of cancer in women—esophagus, liver, and larynx, for example—increased only among those women in the study who also smoked.

Specifically, Raloff recommends that women with a genetic predisposition for breast cancer might decide that “no alcohol is the best policy.” And for people at low risk for heart disease, it’s difficult to justify drinking because it’s good for your heart. However, “study after study has offered quantitative evidence that middle-age and older adults who take a regular nip—like that proverbial glass of sherry after dinner or at bedtime—suffer less heart disease and diabetes than teetotalers or people who consume more than two drinks a day.”

And that, at present, is where the matter still stands. As Raloff sensibly concludes, “Let’s not scare people with incomplete data. There will be plenty of time to hammer home a call for temperance if and when stronger data emerge.”

Photo Credit: www.injuryboard.com

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Tobacco Industry Loses Crucial Court Case

Jury awards $8 million to widow of addicted smoker.

In a court decision that attorneys for Philip Morris called “profoundly flawed,” a Florida jury last week awarded $8 million to the widow of a man who died of lung cancer, ruling that nicotine addiction was the cause of his death.

Attorneys for Altria, the parent company of Philip Morris, argued in Hess v. Philip Morris USA that the deceased man had been fully aware of the dangers of smoking, and had been fully capable of quitting, had he chosen to do so.

Philip Morris will most certainly lodge an appeal, given that the closely-watched “Hess case” is the first of an estimated 8,000 similar cases filed in Florida in the wake of a class-action suit against cigarette makers in 1994. In 2006, the class-action suit was overturned by the Florida Supreme Court, which ruled that smokers had to prove in individual court cases that cigarettes were the immediate cause of their health problems.

Attorneys for the widow, Elaine Hess, argued that Philip Morris sold cigarettes that were “defective and unreasonably dangerous,” according to a Miami Herald report by Patrick Danner. Phillip Morris attorneys argued that smoking had simply been a “lifestyle choice” for Stuart Hess. Hess, the tobacco lawyers asserted, voluntarily chose not to follow the advice of family members and doctors, who told him to quit smoking.

According to the Miami Herald report, Hess “tried various means to quit smoking, including hypnosis, Nicorette gum and even going cold turkey. But all of his attempts failed.”

While technically the Hess case has no bearing on the individual court cases to come, attorneys said it was expected to serve “as a template for the other cases,” Danner wrote in the Herald article. Murray Garnick, a senior vice president and associate general counsel for parent company Atria, said in a press release that the verdict was the result of “an unconstitutional and profoundly flawed trial procedure. Fundamental fairness requires the plaintiff to establish basic liability before a jury can award damages.”

Photo Credit: http://snus-news.blogspot.com/2008_01_06_archive.html

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