2013-04-02

[DIV28SUPER] FDA response to citizen petitions on Nicotine containing products

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm345928.htm?source=govdelivery

"....

Nicotine-Containing Products

FDA has issued a citizen petition response and a Notice of Findings related to over-the-counter (OTC) nicotine replacement therapy (NRT) products, which are currently approved as aids to smoking cessation.

Citizen Petition Response

In January 2008, The State of New York's Commissioner of Health submitted a citizen petition to the Agency asking FDA to take various actions regarding the regulation of OTC NRT drug products. In February 2010, the University of Maryland School of Law submitted a petition raising similar issues on behalf of the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco. We received a third petition in August 2010, from four not-for-profit public health organizations: the American Cancer Society Cancer Action Network, the American Lung Association, the Campaign for Tobacco-Free Kids, and the American Legacy Foundation. These three petitions raise many common issues, so FDA issued a combined response granting and denying the various requests made in the petitions.

Notice of Findings

Each of the citizen petitions described above requested changes to approved drug product labeling for OTC NRT products. Because changes to the labeling of OTC NRT products must be supported by submissions from product sponsors to the appropriate New Drug Applications, FDA was unable to make the requested labeling changes through the citizen petition process. The Agency has, however, conducted its own review of the available literature and data on the safety of OTC NRT products. Based on that review, we have concluded that certain statements set forth in the approved labeling of OTC NRT products, including statements related to duration of use and concomitant use with other nicotine-containing products, can be modified. FDA intends to allow the modification of these statements based on sponsor submissions as set forth in a Notice of Findings.

Product sponsors may contact CDER's Division of Nonprescription Clinical Evaluation for samples of what the new labeling would look like with the changes supported by the Notice of Findings.

Contact:

Doris J. Bates, Ph.D.

Center for Drug Evaluation and Research

Food and Drug Administration ...."

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2013-04-01

[DIV28SUPER] Not an April Fool's Joke!

No… this is NOT an April Fool’s joke! There is STILL time to register and attend the Inaugural Collaborative Perspectives on Addiction Conference!

Your registration includes:

1) Two amazing keynotes by Saul Shiffman and Edith Sullivan

2) Up to 13.5 hours of CE!

3) Two amazing poster sessions chalked full of research

4) Free lunch and presentation by Harold Perl of NIH: “Peeking Behind the Curtain of the NIH Funding Process: Tips for Preparing a Successful Grant Application”

5) 10 symposia to choose from (see below for list)

6) Networking and camaraderie over two social hours!

7) A chance to visit the heart of the South and all that Atlanta has to offer!

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The following sessions will be presented at the upcoming 2013 Collaborative Perspectives on Addiction Conference.

>BEHAVIORAL ECONOMIC PERSPECTIVES ON ADDICTION
The field of behavioral economics, or the study of economic decision-making with behavioral experimentation, has contributed a great deal to the understanding of addiction and the altered decision-making patterns often seen in addiction. In this session, four behavioral economic researchers (Warren Bickel, James MacKillop, James Murphy, and Mikhail Koffarnus) will present recent research in this area and discuss the unique contributions of behavioral economics to the understanding of addiction.
Warren Bickel, PhD; Mikhail Koffarnus, PhD; James MacKillop, PhD; James Murphy, PhD

>APPLYING CLINICAL NEUROSCIENCE TO THE TREATMENT OF ADDICTION
Addiction is a chronic and relapsing disorder affecting millions of patients worldwide. Extensive preclinical research has elucidated some of the key neurobiological underpinnings of addiction, yet these findings have not been translated into clinical practice. This workshop will review addiction neurobiology while applying theses insights to the understanding of the clinical phenomenology and treatment of the disorder. Participants will learn how to integrate key findings from addiction neuroscience into the psychological treatment of addiction.
Kelly Courtney, PhD; Lara Ray, PhD

>BIOBEHAVIORAL PERSPECTIVES ON MECHANISMS OF BEHAVIOR CHANGE: BRAIN, BODY, MIND, AND CONTEXT
This session will introduce some “out of the box” biobehavioral perspectives on research and practice approaches to identifying and manipulating mechanisms of behavior change in addictions. The construct of arousal will be probed at the level of the brain, the body, the mind, and in social interaction. Implications for developing a multi-level explanatory framework to understand behavior change will be discussed. Video clips and audience-involved demonstrations will be included.
Marsha Bates, PhD; David Eddie, MS; Jon Morgenstern, PhD; Robert Zucker, PhD, ABPP

>CO-MORBID INHALANT USE AND COMPULSORY BEHAVIORS: IMPLICATIONS FOR RED-FLAG ASSESSMENTS AND STRATEGIES FOR CLINICAL CARE
The present study explored the relationship between compulsory behaviors, trauma history, and increased prevalence of inhalant abuse in females versus males in adolescent substance users. A major focus of this study was to provide practical guidelines for clinicians treating adolescents with substance use disorders by way of assessment and treatment planning strategies. The findings are tied directly into strategies for treatment planning in a tangible attempt to bridge the divide between research and clinical practice.
Robert Daniels, MA; Tommi Rivers, BA

>INTERDISCIPLINARY TREATMENT TEAMS FOR ADDICTIVE DISORDERS ON COLLEGE CAMPUSES
This symposium describes the methods and benefits of integrated, interdisciplinary treatment team approaches for eating disorders and alcohol and other drug (AOD) abuse on a college campus.
Irene Dalton, PhD; Abby Myers, PhD; Shannon Croft, MD; Kelita Wiley, MD

>MEDIATORS OF THE ASSOCIATION OF DEPRESSION WITH SMOKING CESSATION
This study examined the mechanisms linking depression to smoking cessation in an ethnically diverse sample (N=424). Greater depression was associated with significantly lower cessation rates. Positive affect, stress, self-efficacy, expectancies of controlling negative affect by means other than smoking, affective withdrawal symptoms, and social support individually mediated the effect of depression on smoking cessation. However, when taking into account other significant mediators, only self-efficacy and sadness uniquely mediated the effect of depression on smoking cessation.
Virmarie Correa Fernandez, PhD; Whitney L. Heppner, PhD; Diana Stewart, PhD; Amanda Mathew, MA

>MEDICATION DEVELOPMENT: TRANSLATING RESEARCH INTO PRACTICE
This breakout session examines the development and implementation of medication for the treatment of alcohol and drug use disorders. Presentation 1 discusses development of an immunotherapy for methamphetamine use. Presentation 2 reports on the system changes required to promote the use of medication. Presentation 3 examines the use of medication within addiction treatment centers. Presentation 4 is a case study of medication use in a community-based treatment center participating in the Clinical Trials Network.
John Gardin; Jennifer Loftis; Dennis McCarth; Traci Rieckmann

>NEUROECONOMICS AS A FRAMEWORK FOR TRANSLATIONAL RESEARCH ON ADDICTION
Neuroeconomics is an interdisciplinary research approach that has characterized neural abnormalities underlying pathological decision making in individuals who misuse a variety of substances. The four talks in this session will highlight recent neuroeconomics research in addiction with a particular focus on neuroimaging studies of impulsive delay discounting and substance demand along with pharmacological and genetic influences on these variables. An interactive panel discussion will focus on translational implications for interventions for addictive disorders.
Michael Amlung, MS; Charlotte Boettiger, PhD; James MacKillop, PhD; Joseph Schacht, PhD

>THE APPLICATION OF CLINICAL NEUROSCIENCE IN TREATING ADDICTIVE DISORDERS
This symposium highlights the application of clinical neuroscience in understanding and treating addictive disorders. Review of recent studies and the role of psychopharmacology and integrative treatment will be discussed.
Meghan Marcum, PsyD

>UNDERSTANDING AND TREATING THE CO-OCCURRING DISORDERED CLIENT
This session will explore the underlying characteristics of individuals with confounding mental health and substance use disorder issues and will explore specific treatment strategies for this population.
Vito DonGiovanni, PhD

· Conference Website, Registration, and Hotel: www.tinyurl.com/2013CPA

· See who’s registered so far! https://divisions.wufoo.com/reports/2013-cpa-attendee-directory/

· See all the details on the attached Brochure

ABOUT THE CONFERENCE

The theme for the 2013 conference is "Biobehavioral RESEARCH & Implications for PRACTICE"

· Atlanta, Georgia / May 3-4, 2013

· Two thought-provoking keynote sessions

· Interactive environment for collaboration/networking

· Several breakout session choices

· Poster Sessions

· Pre-conference in-depth workshops

· Discounted rates for Early Career Psychologists

· Student opportunities (discounted rates, special networking, etc)

· You don't have to be a member of either or division or APA to attend the conference!

· 13.5 hours of CE are available AND included in the price

MEET THE KEYNOTERS

· Saul Shiffman, PhD, is a world-renowned researcher in the fields of behavior change and relapse, self-management and self-control, field research methodology, statistical analysis, and addiction and dependence. Since 1991, he has been a professor in the departments of psychology and pharmaceutical science at the University of Pittsburgh. Dr. Shiffman has taught in the departments of psychology and psychiatry and behavioral medicine at various universities, including the University of South Florida, the University of Washington, and the University of Pittsburgh. Dr. Shiffman has authored or co-authored over 300 published papers on a variety of topics related to psychopharmacology, substance abuse, dependence, relapse, coping, and computerized assessments of behavior, and has presented widely in medical and scientific forums. A fellow of numerous professional societies (including APA Divisions 28 and 50), Dr. Shiffman was awarded the Society for Research on Nicotine and Tobacco’s Ovid Ferno Award for “ground breaking advances in clinical research.”

· Edith V. Sullivan, PhD, is professor of psychiatry and behavioral sciences at Stanford University School of Medicine and a neuropsychologist who has pioneered the study of alcoholism-related brain injury on selective cognitive and motor function. She is the recipient of a Senior Scientist Research and Mentorship Award, a grant for international collaborations on alcoholism research, and an NIAAA MERIT award for studies of neural circuitry modification in alcoholism focused on frontocerebellar systems. Dr. Sullivan is a recipient of the Research Society on Alcoholism Distinguished Researcher Award and is author of more than 250 peer-reviewed papers and numerous chapters and reviews. Dr. Sullivan will present a keynote address on Saturday, May 4, titled “Alcoholism and the Brain: Road to Ruin and Path to Recovery.”

PRE-CONFERENCE WORKSHOP

"Conducting Neuroimaging Studies from a Neuropsychologist’s Perspective"

Integrating neuroimaging techniques with neuropsychological and other neurobehavioral methods is often a powerful approach in human studies. Many applicants underappreciate the critical processes that enable a) identification of appropriate team members, b) building cohesion among members, and c) sustaining individual commitment and engagement throughout the project. Furthermore, psychologists without neuroimaging expertise often fail to fully utilize the expertise of their collaborators and thus struggle to communicate the import of their data. Building on existing literature and her own experiences, Dr. Mattson’s workshop focuses on essential steps in defining effective, productive and innovative teams from the perspective of “non-imagers.”

Presenter: Sarah Mattson, PhD (Pre-Registration Required)

LUNCHEON PRESENTATION

“Peeking Behind the Curtain of the NIH Funding Process: Tips for Preparing a Successful Grant Application”

Applying for NIH research funding can be a daunting prospect, especially in a tough budget environment, yet thousands of submissions are funded in every cycle. Successful applications are not just based on important and innovative ideas but how those ideas are formulated and presented. Dr. Harold Perl is a 23-year veteran of NIDA and NIAAA. He presents an in-depth analysis of the application process that will help investigators at all levels enhance their grantsmanship and increase their chances of success. Attendees also will get an illuminating behind-the-scenes look at the review and funding process from this key NIH “insider.”

Presenter: Harold Perl, PhD, the Chief of the Prevention Research Branch at NIDA. Presentation includes complimentary luncheon; all attendees welcome.

ABOUT THE VENUE

The beautiful W Hotel in Midtown Atlanta will be the venue for our First Annual Conference. The hotel is located in the heart of Midtown and is local to public transportation. Room rates are $159 per night. Reserve your room now!

MORE INFORMATION

Sara Jo Nixon, PhD, Conference Chair

Anthony Liguori, PhD, Conference Co-Chair

John Kelly, PhD, Sponsorship Co-Chair

Katie Witkiewitz, PhD, Sponsorship Co-Chair

Jennifer Buckman, PhD, Conference Treasurer

Chad Rummel, MEd, Registration and Hotel Accommodations (202-336-6121)

Conference Website and Registration: www.tinyurl.com/2013CPA

______________________________________________

Chad Rummel, MEd | Registration and Meeting Planner

2013 Collaborative Perspectives on Addiction Conference

Division Services Office | Governance Affairs

CODAPAR Staff Liaison

American Psychological Association

750 First Street NE, Washington, DC 20002-4242

Tel: (202) 336-6121 | Fax: (202) 218-3599 | crummel@apa.org

Join divisions online at www.apa.org/divapp

2013-03-31

[DIV28SUPER] NYTimes: As OSHA Emphasizes Safety, Long-Term Health Risks Fester

We continue failing to regulate neurotoxicants in the workplace. Just another poignant story (with video) in a long sequence of disasters easily prevented by legislative intervention and regulatory intervention. The casualties wind up on disability and Medicaid and suffer needlessly everyday.

these are typically silent issues that escape attention and hence don't get the legislative attention necessary to "do the right thing". Meanwhile, this chemical joins hexane, mibk, lucel7.. A long list of tragedies easily prevented by testing programs, regulatory processes, and industrial hygiene

From The New York Times:

As OSHA Emphasizes Safety, Long-Term Health Risks Fester

The Occupational Safety and Health Administration, the agency that many Americans love to hate and industry calls overzealous, has largely ignored the slow, silent killers that claim the most lives.

http://nyti.ms/X4GQZg

Sent from my iPad
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2013-03-28

[DIV28SUPER] APA International Awards - Calls for Nominations

Division 28 members:

Please see the attached Calls for Nominations for the 2014 APA International Humanitarian Award and the 2014 APA Award for Distinguished Contributions to the International Advancement of Psychology.

The deadline for nominations is June 1, 2013.

Anthony Liguori, PhD
President, Division 28

Department of Physiology and Pharmacology
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.8543 \ f 336.716.8501
aliguori@wakehealth.edu \ WakeHealth.edu

2013-03-27

[DIV28M] ACTION ITEM: Psychologists working in addictions need your action!

ADVOCACY REQUEST!

PSYCHOLOGISTS WORKING IN ADDICTION NEED YOUR ACTION

TO: All licensed psychologists

All students preparing to be licensed psychologists

Psychologists who work in the area of addictions treatment and training need your help. Specifically we need you to alert appropriate stakeholders to sign a petition to alert the Board of Directors of the American Psychological Association (APA) to a problem that needs attention: The certificate for the Recognition of Proficiency in the Psychological Treatment of Alcohol and Other Psychoactive Substance Use Disorders needs reinstatement. To sign go to http://www.ipetitions.com/petition/reopening/ .

Background

APA formally recognized Division 50, now known as the Society of Addiction Psychology (SOAP), in 1993. The division serves the needs of the field and psychologists who work in the area of addictions treatment, research, and training. Together with Division 28 (Psychopharmacology & Substance Abuse), many psychologists worked for years to establish a Proficiency in the Psychological Treatment of Alcohol and Other Psychoactive Substance Use Disorders. The Commission for the Recognition of Specialties and Proficiencies in Professional Psychology (CRSPPP) formally recognized the proficiency in 1993. Thereafter, the College of Professional Psychology within APA began to offer a certificate of recognition for the proficiency to licensed psychologists successfully demonstrating their knowledge and experience. To gain a certificate, an applicant needed to demonstrate stature as a licensed psychologist in any state, relevant experience, passing an exam, and maintenance of regular continuing education in the area of addictive behaviors.

The proficiency itself has been renewed on two occasions and stands through 2015. The proficiency and its need are not in doubt. Instead, what is at stake is the availability of the certificate of recognition. This is a useful tool for practitioner credibility within the marketplace and with official stakeholders such as insurance providers. It also provides psychologists with a means to have a credential developed and maintained by psychologists, appropriate to our level and field of preparation, for work in this area. This is in marked contrast to psychologists needing to see credentials from non-doctoral and non-psychological organizations, a situation that is now in place since the retirement of the certificate by APAin January of 2011.

This decision to retire the certificate took place more than two years ago, without input from Division 50 board. Since our discovery of this decision, we have engaged on numerous occasions with APA staff in person and in writing. The goal of these communications has been to determine how and who made the decision, the basis of the decision, how this affects psychologists already holding the certificate, and opportunities to reverse the decision.

What we discovered in this process is that the decision derived from financial concerns. Licensed psychologists were not signing up in sufficient numbers to support the effort needed to sustain the certificate financially. The effort to maintain an offering includes such things as staff time to address inquiries, create and manage advertising, manage records related to continuing education and certificate status, and managing processes around the offering of an exam, including maintenance of the exam as valid.

What is important is that the division still maintains the proficiency. The proficiency itself is still recognized by APA and several states as a valid and useful credential. APA's College of Professional Psychology also is continuing to maintain certificate renewals for individuals who already have it. Additionally, however, the current state of affairs remains that there is no ability for new practitioners to get the certificate through APA.

This creates a barrier to new and seasoned practitioners in the field who seek such a credential for the current and future marketplace. This is both unfair within our profession and creates credibility problems for those who do not have the certificate relative to those who do have it.

This is also happening at a time when discussions of the need for a national credential are taking place both for clinical and even training in this area. This has been evidenced by discussions and public presentations at national meetings of addictions counselors (NADAAC) and organizations focused on addictions training at all levels of preparation (INCASE). These organizations also seek and are prepared to push for legislation to have their states require credentials to teach and practice in addictions, irrespective of any other license they may have.

Action Requested

In light of these changes to healthcare reform, particularly related to mental health and addiction parity, opportunities to provide addictions services will increase. And so psychologists need to put their best foot forward and be prepared to meet this need.

To this end, we ask you to sign our petition to the APA Board of Directors to:

1. Immediately reinstate the certificate for the recognition of the Proficiency in the Psychological Treatment of Alcohol and Other Psychoactive Substance Use Disorders;

2. Work collaboratively with the Society of Addiction Psychology (Division 50) to develop a long-term plan to maintain the utility of the certificate for licensed psychologists;

3. Work collaborative with all current and future licensed psychologists to insure access to an appropriate credential for psychologists in addiction so that they are not at risk for having their teaching, training, and clinical work inappropriately impinged upon by standards of other professional groups;

4. Work collaboratively with the APA Council to insure no certificate for proficiency is retired without discussion by all stakeholders.

To sign, please go to: http://www.ipetitions.com/petition/reopening/ .

Signers must be licensed psychologists or students who plan to seek licensure as a psychologist.

For more information, please send us any questions or communications through the link at the petition site.

We thank you for your attention.

- The Division 50 Board

P.S.

If you would like an article to publish in a newsletter in your local about this matter, please contact me.

I am happy to make one available to you to help you get the word out on this issue.

Nancy A. Piotrowski, Ph.D.

Core Faculty, General Psychology & Lead, Addiction Psychology

Harold Abel School of Social and BehavioralSciences

Department of Psychology, College of Professional Studies, Capella University

Federal Advocacy Coordinator, Division 50, American Psychological Association

Past President, Napa Solano Psychological Association

Website Chair, San Francisco Psychological Association

3450 Geary Boulevard, Suite #107

San Francisco, CA 94118

Phone & FAX by request

Email: napiotrowski@yahoo.com

ALT Email: PiotrowskiConsultation@gmail.com

Skype: napiotrowski

"Not all those who wander are lost..." -J.R.R. Tolkien, 1954.

[DIV28SUPER] Table of Contents, Experimental and Clinical Psychopharmacology, April 2013

Attached is the table of contents for the April 2013 issue of Experimental and Clinical Psychopharmacology. Please note that this issue will include a Call for Papers for an upcoming issue on Ethical, Regulatory, and Practical Issues in Telepractice.

Div28