FDA Meeting on Opioid REMS Highlights the Need for Comprehensive, Integrated Risk Management

FDA Meeting on Opioid REMS Highlights the Need for Comprehensive, Integrated Risk Management

Inflexxion is uniquely positioned to assist companies with risk evaluation and mitigation strategy plans

Newton, MA (PRWEB) March 2, 2009 -- On Tuesday, March 3rd, the FDA will meet with manufacturers of extended-release (ER) opioid medications for what's expected to be the beginning of a process to develop a new Risk Evaluation and Mitigation Strategy (REMS) program. According to the Agency, strategies for minimizing the risks of opioid medications -- which have included FDA-required risk minimization and action plans, or RiskMAPs -- need to be strengthened.

"Despite [the efforts of the FDA, drug manufacturers, and other stakeholders, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," states the Agency in a media release announcing the meeting. Crafting a new REMS program, the Agency says, will entail "discussions with other federal agencies and non-government institutions, including patient and consumer advocates, representatives of the pain and addiction treatment communities, other health care professionals, and other interested parties."

Inflexxion, a company that is deeply engaged with the pain and addiction treatment communities, is uniquely prepared to assist manufacturers, federal agencies, and other stakeholders with creating a comprehensive REMS. In 2001, the company's pharmaceutical risk-management division launched development of the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) with support from the National Institutes of Health (NIH). Now a nationally recognized public health-oriented substance risk management solution, NAVIPPRO integrates the four key components of an effective REMS: national, "real-time," product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.

"One of the key elements distinguishing REMS from RiskMAPs is the requirement for ongoing evaluation of the efficacy of a program, both by the FDA and the sponsor of the drug, so adjustments can be made to ensure that risk-mitigation goals are being met," says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "NAVIPPRO is designed to assist with this type of long-term, continuous evaluation."

In a recent study of NAVIPPRO data published in Pharmacoepidemiology and Drug Safety (December 2008, Volume 17, Issue 12), the authors evaluated the surveillance component of the program. Analyzing NAVIPPRO's proprietary, "real-time" data stream, de-identified client assessment data continuously collected from the ASI-MV® Connect network of substance abuse clinics across the U.S., they examined the representativeness, geographic coverage, and timeliness of report of the data. They found that the data allow for the characterization of product-specific and geo-spatial differences for drug abuse, and can serve as a tool for monitoring the responses of the treatment center population to particular drug formulations.

According to Zacharoff, the findings show that NAVIPPRO data can be useful for measuring, in "real time," the relative rate of abuse of a particular drug in a vulnerable population, and in a specific geographic area of the country. "These data can help detect early signals of an emerging trend of abuse, which in turn allows for targeted prevention and intervention efforts, and for gauging the impact of those initiatives," he says.

To address the need for prevention and intervention, Inflexxion has incorporated into NAVIPPRO its award-winning, empirically validated educational programs. These programs include PainEDU.org, a comprehensive pain education website for health care professionals with nearly 20,000 subscribed clinicians of varying disciplines. As part of its educational offerings, PainEDU provides clinicians with access to clinically tested practice tools, such as the Screener and Opioid Assessment for Patients with Pain (SOAPP®).

Developed by Inflexxion, SOAPP is a brief, pen-and-paper self-report tool that enables health care providers to assess a patient's risk of addiction before initiating opioid therapy. It can be used in concert with the Current Opioid Misuse Measure (COMM)®, a complementary tool for identifying whether a patient, throughout the course of long-term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.

The utility of SOAPP and COMM were recently highlighted in new guidelines by the American Pain Society and the American Academy of Pain Medicine on the use of opioid medications to treat chronic non-cancer pain. The guidelines, published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2), recommend that clinicians routinely conduct a complete benefit-to-harm evaluation before starting opioid therapy, and do periodic follow-up screenings of patients who may be at risk for abuse or addiction.

"In the past, drug sponsors and consultants worked individually on programs designed to minimize risk in a hit-or-miss fashion, with very little modification of the initiatives based on outcomes. I believe that the FDA hopes that this new REMS development process will provide an opportunity for these groups to come together, working more closely to ensure that patients are treated appropriately, based on collected data, with the best medications available, and the highest level of safety and vigilance," says Zacharoff. "We at Inflexxion are committed to assisting all stakeholders - including the manufacturers, the FDA, and health care providers - in successfully navigating these issues and together improving the risk-benefit balance of opioid medications."

To learn more about NAVIPPRO, visit the website (www.navippro.com).

About Inflexxion, Inc.

Founded in 1989, Inflexxion creates innovative, award-winning behavioral health solutions for prevention, education, and disease management. Our grant-funded, clinically tested programs address substance abuse and addiction, chronic pain management, and other health and wellness issues. Our pharmaceutical risk management division provides Risk Evaluation and Mitigation Strategy (REMS) assistance to companies that research, manufacture, and market opioid pain medications and other therapeutic agents with potential abuse problems. Key offerings include NAVIPPROTM, ASI-MV® Connect, PainEDU.org, painACTION.com, and SOAPP®. Inflexxion is based in Newton, MA.

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Contact Information Amanda Hemm

Inflexxion, Inc.

http://www.NAVIPPRO.com

617-614-0436

Colleges Need Speakers for Orientation Session with New Students

Colleges Need Speakers for Orientation Session with New Students

Top Speaking Coach Shows Speakers, Authors, Consultants, and Coaches How to Get Lucrative Speaking Engagements

Las Vegas (Vocus) February 27, 2009 -- College orientation sessions remain an untapped gold mine for speakers, authors, coaches and consultants, says James Malinchak, who was twice voted the Number One speaker on the college circuit. Malinchak teaches people how to profit by speaking to the collage market in his Millionaire Speaker Bootcamp (http://www.millionairespeakerbootcamp.com/promo).

"You could be losing a ton of money by not speaking for college orientations," he said. "College Orientations are one of the most overlooked, lucrative speaking niches."

If you're wondering what Orientation is, this is a time period when the college or university hosts all of the in-coming freshmen and transfer students (and their parents or spouses) for a few days up to an entire week where school representatives inform and educate the students, parents and spouses about the school, location of buildings, where to get tutors, dormitory and apartment living, etc. Basically, it's a time where school representatives help students, parents and spouses get acclimated with the college or university.

College Orientation is usually held August and September and also January and February, but some schools hold their Orientation in the summer. Some schools will even do two different Orientation events.

"There's one school that brings me in twice a year, for both their August and January Orientation programs. There's another school that pays me $10,000 a year every March to deliver four talks in two days to their incoming students," Malinchak said. "Speaking for college Orientation events is one of the most lucrative times of year for speakers. I have speaker friends who make a big money during this time."

For more information about the Millionaire Speaker's Bootcamp, go to http://www.millionairespeakerbootcamp.com/promo.

About James Malinchak

From a small Pennsylvania steel-mill town, to self-made speaker millionaire in his 20's, James Malinchak is a true American success story whose unique speaker-marketing strategies has helped hundreds of speakers, coaches and consultants build successful speaking businesses. He runs a 7-figure speaking, training, seminar and coaching business.

He has delivered over 2,200 college, corporate & youth presentations worldwide for audiences ranging from 20 to 12,000, and has done so without the use of bureaus, without being famous, without any advanced academic degrees & without any speaker designations from any speaker associations.

Malinchak is the author of 16 books including ''Chicken Soup for the College Soul'' & the upcoming ''Chicken Soup for the Athlete's Soul.'' He has been profiled in numerous publications including Millionaire Blueprints.

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Contact Information Dan Janal

http://www.millionairespeakerbootcamp.com/promo

952-380-1554

Coaches, Consultants, Authors and Speakers Can Learn Secrets for Surviving in Difficult Times with Five Free Reports from Top Speaking Coach

Coaches, Consultants, Authors and Speakers Can Learn Secrets for Surviving in Difficult Times with Five Free Reports from Top Speaking Coach

Coaches, consultants and speakers and authors can learn the secrets to success in the speaking business when they access five free reports from James Malinchak, who runs the Millionaire Speaker's Bootcamp. Malinchak teaches people how to profit by speaking to the collage market in his Millionaire Speaker Bootcamp (http://www.millionairespeakerbootcamp.com/promo).

Las Vegas (Vocus) February 26, 2009 -- Coaches, consultants and speakers and authors can learn the secrets to success in the speaking business when they access five free reports from James Malinchak, who runs a 7-figure speaking, training, seminar and coaching business. Malinchak teaches people how to profit by speaking to the collage market in his Millionaire Speaker Bootcamp (http://www.millionairespeakerbootcamp.com/promo).

"I truly believe you would grow your business tremendously by following the information in these reports. I should know because that's exactly what happened to my speaking income when I finally figured out this was the key that opened the treasure chest to a speaking fortune!" said Malinchak.

Malinchak is offering five special reports at his website (http://www.millionairespeakerbootcamp.com/promo)

- Free Special Report: ''Millionaire Speaker Secrets'' where you will learn the insider secrets to really making Big Money as speaker.

- Free Audio Download: ''Millionaire Speaker Secrets'' Over one-hour packed with quality content to show you how to go from scratch to over a million dollars as a speaker.

- Free Special Report: ''10 Deadly Speaker Marketing Mistakes'' Discover how to avoid these 10 business killers and market yourself like a pro ... even if you aren't.

- Free Subscription to my Big Money Speaker e-zine. Bi-weekly no-nonsense tips and tricks to get the fees you deserve, sell massive amounts of products, and live the life you have been dreaming of.

- Free Information on my Systems for Selling Your Products, Speaking at Colleges & Speaking for Businesses.

For more information about the Millionaire Speaker's Bootcamp, go to http://www.millionairespeakerbootcamp.com/promo.

About James Malinchak

From a small Pennsylvania steel-mill town, to self-made speaker millionaire in his 20's, James Malinchak is a true American success story whose unique speaker-marketing strategies has helped hundreds of speakers, coaches and consultants build successful speaking businesses. He runs a 7-figure speaking, training, seminar and coaching business.

He has delivered over 2,200 college, corporate & youth presentations worldwide for audiences ranging from 20 to 12,000, and has done so without the use of bureaus, without being famous, without any advanced academic degrees & without any speaker designations from any speaker associations.

Malinchak is the author of 16 books including ''Chicken Soup for the College Soul'' & the upcoming ''Chicken Soup for the Athlete's Soul.'' He has been profiled in numerous publications including Millionaire Blueprints

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Contact Information Dan Janal

http://www.millionairespeakerbootcamp.com/promo

952-380-1554

Problem Gambling Awareness Week: Shining the Light on Problem Gambling's Impact on Crime

Problem Gambling Awareness Week: Shining the Light on Problem Gambling's Impact on Crime

Governor Charlie Crist has proclaimed the week of March 1st through 7th as Problem Gambling Awareness Week in the State of Florida, to coincide with the nationally declared awareness week. The Florida Council on Compulsive Gambling (FCCG) is joining forces with the Governor, numerous mayors and organizations across the state, to raise public awareness about the effects of pathological (commonly referred to as compulsive) gambling, and spread the message of hope that gambling addiction is treatable for those who seek help. The theme for this year's PGAW is Shining the Light on Problem Gambling with a focus on the impact compulsive gambling has on crime.

(PRWEB) February 25, 2009 -- Today, the Florida Council on Compulsive Gambling (www.gamblinghelp.org) (FCCG) announced that Governor Charlie Crist has proclaimed the week of March 1st through 7th as Problem Gambling Awareness Week in the State of Florida, to coincide with the nationally declared awareness week. The Florida Council on Compulsive Gambling (FCCG) is joining forces with the Governor, numerous mayors and organizations across the state, to raise public awareness about the effects of pathological (commonly referred to as compulsive) gambling, and spread the message of hope that gambling addiction is treatable for those who seek help. The theme for this year's PGAW is Shining the Light on Problem Gambling with a focus on the impact compulsive gambling has on crime.

According to statistics from the Florida Council on Compulsive Gambling 24 Hour HelpLine from January 2008 through January 2009:

•    Almost one in every three callers (30%) admit to committing illegal acts to finance their gambling, committing crimes that are linked to money.

•    Almost two out of three callers (62%) reported committing fraud, writing bad checks or forgery

•     One out of five callers (21%) stated they had embezzled money for employers

•    One out of five callers (21%)claimed to have committed larceny or theft against friends, family members or strangers

•    One out of 14 callers (7%) stated they had been involved with other illegal activities such as selling drugs, prostitution, illegal gambling (booking) and others

Further legal actions had been enacted against the gambler for their activities in 20% of the contacts

•    One out of ten (11%) had been arrested and given probation

•    Almost one out of every four callers (24%) had been arrested and sent to jail/prison and received probation

•    One out of three callers (64%) had civil actions brought against them such as lawsuits for failure to repay debts (credit cards, loans, and child support), divorce, foreclosure of residence and others

According to Pat Fowler, Executive Director for the Council, "There are more than one million Florida residents who struggle with difficulties due to gambling. As the number of people addicted to gambling increases, a new population of those committing crimes is created. Many of these individuals have no prior history of violating the law, and appear to have done so only as a result of their gambling addiction. Just review some of the recent media reports."

DCF SUPERVISOR gets 17 years in prison for embezzling 1.54 million dollars. The money was used by the DCF supervisor and her 2 friends to gamble, each of whom were sentenced to 10 years in prison. The DCF supervisor took advantage of knowledge of the DCF system to fraudulently gain access to funds that were set aside for social services and underprivileged people. Sun-Sentinel, 2008

LUXURY AUTO DEALER embezzles $500,000 to fuel gambling habit (online and sports betting). He would funnel petty cash funds ($20,000 at a time) in his accounts. St Petersburg Times, 2007

CLEARWATER ACCOUNTANT steals 1.6 million dollars to fund addiction (horse betting). He was an accountant for a law firm and transferred firm funds to his personal accounts. Tampa Bay 10, 2009

DELRAY BEACH PRIESTS embezzle over 8 million dollars to fund gambling trips and lavish lifestyles. Palm Beach Post, 2009

WEIGHT WATCHERS is suing a casino where ex-bookkeeper lost large amounts of money she embezzled. The branch she worked for was the main location for Southern Alabama and Northern Florida. The worker embezzled almost 1 million to fund her gambling addiction. Clarion Ledger, 2009

FLORIDA HIGHWAY PATROL TROOPER loses his job after admitting that he took money from people, he believed to be illegally in this country, during traffic stops. He admitted that he used the money because of a drinking and gambling problem. Orlando Sentinel, 2009

These are just a few of the stories that recently made headlines involving embezzlement and white collar crime.

Problem Gambling Awareness Week provides the Council with an opportunity to partner with the state and local organizations to raise the awareness and shine the light on problem gambling. We hope numerous others will join the FCCG in this initiative to raise awareness of the issue, so that those in need can find help. For more information, call 888-ADMIT-IT, or visit us online at www.gamblinghelp.org.

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Contact Information Pat Fowler

The Florida Council on Compulsive Gambling

http://www.gamblinghelp.org

407-865-6200

Clinical Guidelines for Treating Chronic Pain Highlight Opioid Addiction Risk Assessment

Clinical Guidelines for Treating Chronic Pain Highlight Opioid Addiction Risk Assessment

Expert panel finds that SOAPP® is likely to be helpful for risk assessment and stratification

Newton, MA (PRWEB) February 25, 2009 -- Inflexxion, Inc., a company that creates scientifically validated and cost-effective solutions for critical areas of health care, is pleased to announce that its Screener and Opioid Assessment for Patients with Pain (SOAPP) has been identified by an expert panel as likely to be helpful for assessing the risk of opioid addiction in patients with chronic non-cancer pain.

SOAPP is a brief paper-and-pencil self report tool that allows clinicians to assess a patient's risk of addiction before initiating opioid therapy.

The multi-disciplinary panel of experts, convened by the American Pain Society and the American Academy of Pain Medicine, conducted a comprehensive review of the evidence to develop a set of authoritative clinical guidelines on the use of opioid medications to treat chronic non-cancer pain. The guidelines, published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2), recommend that clinicians routinely conduct a complete benefit-to-harm evaluation before starting opioid therapy, and do periodic follow-up screenings of patients who may be at risk for abuse or addiction.

"Proper patient selection is critical and requires a comprehensive benefit-to-harm evaluation that weighs the potential positive effects of opioids on pain and function against potential risks," write the authors. "Thorough risk assessment and stratification is appropriate in every case."

According to the authors, screening tools that assess the potential risks associated with continuous opioid therapy (COT) based on patient characteristics are likely to be helpful for risk stratification. The authors identify SOAPP Version 1 and the revised version, SOAPP-R, as among the tools that appear to have "good content, face, and construct validity."

In addition to SOAPP, the guidelines highlight the utility of Inflexxion's Current Opioid Misuse Measure (COMM)®, a complementary tool for identifying whether a patient, throughout the course of long-term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.

"We at Inflexxion are very pleased to see both SOAPP and COMM included in these recommendations," says Kevin L. Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "These guidelines underscore the importance of risk assessment and reassessment in this patient population. The inclusion of the SOAPP and COMM in these recommendations helps to validate Inflexxion's mission, which is to help to reduce health-related risks, enhance clinical outcomes, and positively influence quality of care."

The SOAPP and COMM tools are available for download at no cost through Inflexxion's PainEDU website (www.PainEDU.org), along with a clinician tutorial that includes video case examples.

SOAPP was developed by Inflexxion with support from the National Institutes of Health (NIH) and an unrestricted educational grant from Endo Pharmaceuticals.

About Inflexxion, Inc.

Founded in 1989, Inflexxion creates innovative behavioral health solutions for prevention, education, and disease management. Our clinically tested programs address substance abuse and addiction, chronic pain management, college health, and other health and wellness issues. Our pharmaceutical risk management division provides Risk Evaluation and Mitigation Strategy (REMS) assistance to companies that research, manufacture, and market opioid pain medications and other therapeutic agents with potential abuse problems. Key offerings include NAVIPPRO(TM), PainEDU.org, painACTION.com, and SOAPP®. Inflexxion is based in Newton, MA.

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Contact Information Lara Romanowski

Inflexxion

http://www.painedu.org

617-614-0406

How to Get Off Psychiatric Drugs Safely

How to Get Off Psychiatric Drugs Safely

Taper off antidepressants, antipsychotics, benzodiazepines and ADHD Medication without withdrawal side. The new fourth edition book "How to Get Off Psychiatric Drugs Safely" by James Harper, researcher and founder of The Road Back Program, details a proven successful method for tapering off these medications with separate chapters covering each of several classes of drugs.

(PRWEB) February 25, 2009 -- Millions suffering the myriad side effects caused by antidepressants, benzodiazepines, antipsychotics and ADHD medications - from extreme weight gain to a dulled life - want to stop taking the drugs, their doctors would like to have their patients off the drugs, but cannot endure the emotional and physical pain involved with withdrawal or by what is known as discontinuance syndrome. Drug companies now state in the drug descriptions the medications must be tapered off of slowly to help avoid this debilitating withdrawal syndrome. The common withdrawal side effects include; electric brain zaps, nausea, anxiety, strange behavior, insomnia even relapsing into conditions these drugs are supposed to address.

The new fourth edition book "How to Get Off Psychiatric Drugs Safely" by James Harper, researcher and founder of The Road Back Program, details a proven successful method for tapering off these medications with separate chapters covering each of several classes of drugs, from antidepressants, antipsychotics, anti-anxiety medications to ADHD drugs and benzodiazepines. Employing specific vitamins and nutritional supplements, this exact tapering method has been successfully used by more than 30,000 people and is endorsed by doctors across the US, as well as the UK and Europe.

Anyone can use the information in this book, in conjunction with their physician, to come off psychiatric drugs virtually pain-free while often regaining a zest for life and without returning to the condition the drugs were intended to handle. Doctors, who have previously too often been forced to watch patients suffer through withdrawal side effects, can now successfully walk them through this tapering process.

Before the dust could settle on the fourth edition of How to Get Off Psychiatric Drugs Safely, James has taken tapering off psychotropic drugs to a new level. February 23, 2009, James released six additional books titled, How to Get Off Cymbalta Safely, How to Get Off Effexor Safely, How to Get Off Lexapro Safely, How to Get Off Paxil Safely, How to Get Off Prozac Safely, and How to Get Off Zoloft Safely.

Each of these new books directly addresses the side effect nuances found with these specific medications. James plans to publish a new book for each psychoactive medication during 2009.

Available now on amazon.com. "How to Get Off Psychiatric Drugs Safely" can help anyone successfully break the choke hold of psychiatric medications; providing a road back.

James Harper can be reached for interviews and further details at:

(818) 446-2214

www.howtogetoffpsychiatricdrugssafely.com

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Contact Information James Harper

The Road Back

http://www.howtogetoffpsychiatricdrugssafely.com

818-446-2214

UCSF Gallo Study Finds Hormone Disorder Drug Could Help Drinkers Stay Sober

UCSF Gallo Study Finds Hormone Disorder Drug Could Help Drinkers Stay Sober

A drug prescribed for male and female infertility and menstrual disorders could hold the key to a more effective treatment for alcoholism, according to a study by researchers at the UCSF-affiliated Ernest Gallo Clinic and Research Center (www.galloresearch.org).

(Vocus) February 24, 2009 -- A drug prescribed for male and female infertility and menstrual disorders could hold the key to a more effective treatment for alcoholism, according to a study by researchers at the UCSF-affiliated Ernest Gallo Clinic and Research Center (www.galloresearch.org).

The study showed that "alcoholic" rodents, when injected with the drug cabergoline, decreased their alcohol consumption and alcohol-seeking behavior and were less likely to relapse.

Cabergoline, which is marketed under the trade name Dostinex, is approved by the Food and Drug Administration in pill form to treat conditions caused by excess of the hormone prolactin.

The study, led by Dorit Ron, PhD, a principal investigator at the Gallo Center and associate professor of neurology at UCSF, is now on line (February 20, 2009), in the journal "Biological Psychiatry." (See end of news release for link to paper.)

Notably, cabergoline did not impact the rats' consumption of sucrose and, in a subgroup of binge-drinking mice, the drug did not appear to significantly affect intake of water or saccharin.

"This is encouraging," says Ron, "because it demonstrates that cabergoline is specific for alcohol, but does not affect general reward or pleasure. One of the problems with some existing drugs to treat alcoholism is a side effect that decreases pleasure, making compliance an obstacle to sobriety."

The research builds on an earlier, provocative finding by Ron and her colleagues regarding the protein GDNF (glial cell line-derived neurotrophic factor), which they had injected into rats' VTA (ventral tegmental area) brain region, associated with drug-seeking behavior.

In this earlier study, the scientists had trained rats to consume alcohol. Some, like humans, drank in moderation, while others binged. But when GDNF was administered, both heavy and light drinkers lost at least some of their craving for alcohol. This effect became apparent within 10 minutes and lasted at least 24 hours, the scientists discovered. Importantly, administration of GDNF into the brain prevented the rats from relapsing after a period of abstinence.

While the discovery broke new ground, the scientists knew that GDNF could not be used to treat alcoholic humans because its molecule is too large to cross the blood-brain barrier. So, in the present study, Ron and her colleagues looked at cabergoline, a compound that has been shown in cells to increase the expression of GDNF.

After establishing that cabergoline treatment resulted in an increase of the level of GDNF and activation of the GDNF pathway in the rats' VTA, the researchers sought to test its impact on rodents' drinking habits.

Rats underwent a two-month training program in which they learned to press a lever to obtain alcohol. Researchers found that when rats were injected with cabergoline, they were less likely to press the lever. The higher the dose of cabergoline, the lower the number of lever presses reported. The researchers also found that binge-drinking mice consumed less alcohol after cabergoline administration.

In further study, the researchers found that cabergoline was effective in reducing both craving for alcohol and relapse to drinking. Relapse is a critical issue for alcoholic patients trying to stay abstinent.

As further evidence of the interplay between cabergoline and GDNF, alcohol intake was tested on mice that had been genetically engineered to have a single copy of the GDNF gene, and therefore less GDNF in the brain. As expected, the scientists found that the drinking habits of these genetically modified mice were not affected by cabergoline.

Although the results of the study offer fresh hope to problem drinkers, Ron cautions that human clinical trials are needed before cabergoline can be safely prescribed. Higher doses of cabergoline have been used to treat Parkinson's disease and have been linked to heart valve problems.

"However," notes Ron, "we show that in mice and rats, a low dose of the drug is enough to reduce excessive alcohol consumption, alcohol seeking and relapse. The dose is similar to what is given to humans for the treatment of hyperprolactinemia."

Cabergoline may eventually be prescribed for other addictions. A pilot study conducted on cocaine addicts, cited in Ron's paper, reported a substantial reduction in cocaine use.

In the United States, 17.6 million people -- approximately one in every 12 adults -- abuses alcohol or is alcohol-dependent, according to the National Institutes of Health. But there are just three medications approved to treat alcohol dependence -- disulfiram (Antabuse), naltrexone (Depade, ReVia), and acamprosate (Campral).

Lead author of the study is Sebastien Carnicella, PhD, postdoctoral fellow at the Gallo Center. Co-authors are Dao-Yao He, PhD, senior research scientist; Patricia Janak, PhD, associate professor of neurology at UCSF; Selena Bartlett, PhD, director of the center's preclinical development group; Carsten Nielsen, PhD, associate research scientist; and Somayeh Ahmadiantehrani, graduate student.

Research was funded by the National Institutes of Health and the State of California for medical research on alcohol and substance abuse through UCSF.

The Ernest Gallo Clinic and Research Center at UCSF is one of the world's preeminent academic centers for the study of the biological basis of alcohol and substance use disorders. It is the only center studying alcoholism in the United States that is based in a department of neurology. Gallo Center discoveries of potential molecular targets for the development of therapeutic medications are extended through preclinical and proof-of-concept clinical studies.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions and excellence in patient care.

Link to paper: http://tinyurl.com/dh6dnk

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Contact Information Jennifer O’Brien

http://www.ucsf.edu

415-476-2557