Notice of Participation of the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in PAR-09-247, Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)

Notice Number: NOT-DA-11-014

Key Dates

Release Date: April 1, 2011

Issued by

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

Catalog of Federal Domestic Assistance Number:
93.279 (NIDA)
93.272 (NIAAA)

This Notice announces the participation of the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in PAR-09-247, “Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)” (http://grants.nih.gov/grants/guide/pa-files/PAR-09-247.html). 

All other aspects of this FOA remain unchanged, including the continued participation of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK, http://www2.niddk.nih.gov).  

Overview:  Through this Notice, NIDA and NIAAA encourage investigators to propose ancillary studies to NIDDK’s Longitudinal Assessment of Bariatric Surgery (LABS, http://www.niddklabs.org) to assess alcohol and substance use disorders among persons who have undergone bariatric surgery.  Ancillary studies to the existing LABS ancillary study, Teen-LABS (http://www.cincinnatichildrens.org/research/project/teen-labs/), are also encouraged as a part of this amendment.  Both LABS and Teen-LABS are prospective, multicenter observational cohort studies of patients undergoing bariatric surgery that are establishing a better understanding of the long-term physical and mental health consequences for obese individuals who undergo bariatric surgery.  While obesity has been reported to be associated with a lower lifetime risk of substance use disorders, there have been anecdotal reports of obese persons who lose substantial weight subsequently developing alcohol and substance use disorders and engaging in other high risk behaviors.  Of note, a recent retrospective cohort study of persons who had undergone gastric bypass surgery found a decreased rate of death secondary to illnesses including coronary artery disease, diabetes, and cancer, but found an increased rate of death due to non-disease causes, such as accidents and suicide.  This notice encourages additional ancillary studies to investigate alcohol and substance abuse as an integrated part of these important NIDDK initiatives to evaluate the long-term consequences of bariatric surgery among adults and adolescents.        

Background:  The adult LABS consortium was initiated in 2003 as a cooperative agreement with NIDDK.  The consortium includes six clinical centers and a data coordinating center, working in cooperation with NIH scientific staff, to plan, develop, and conduct coordinated clinical, epidemiological, and behavioral research in the field of bariatric surgery.  Over 2,400 persons have been enrolled in the longitudinal follow-up component of the study.  Teen-LABS was initially funded in 2006, also as a cooperative agreement with NIDDK.  A limited competition for renewal is expected to provide an additional five years of funding. Approximately 250 adolescents are expected to enroll for pre-op evaluation and longitudinal follow-up.  In addition, through an ancillary study to Teen-LABS, a demographically matched comparison group of non-operative obese adolescents will also be recruited and followed longitudinally.  Both LABS and Teen-LABS currently include a range of mental health and quality of life measures.      

Eligible Applications:  Examples of the types of projects which would be supported include, but are not limited to:  ancillary studies which would enhance current research efforts evaluating alcohol and substance use behaviors in the LABS and Teen-LABS cohorts (including supplemental analytic applications) or ancillary applications for new studies on alcohol and substance use behaviors.  Current LABS/Teen-LABS investigators and those investigators who are not currently affiliated with LABS/Teen-LABS are eligible to apply.  All application concepts would need to be approved through the Ancillary Studies Sub-Committees of the LABS or Teen-LABS consortia prior to submission for NIH review.  Explicit approval by the PI or program director of the proposed collaborating LABS/Teen-LABS sites is required as a part of the application process. While ancillary studies would generally utilize data or specimens obtained from patients already enrolled in the LABS or Teen-LABS cohorts, they may also propose additional study sites, investigators, specimen and data collection, or participants, as approved by the consortia’s Ancillary Studies Sub-Committees.  Applications should utilize an R01 mechanism and follow all other submission criteria described in the parent ancillary studies announcement (http://grants.nih.gov/grants/guide/pa-files/PAR-09-247.html).  Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK and in accordance with NIH peer review procedures (http://grants.nih.gov/grants/peer/), with peer reviewers having expertise in alcohol and substance use disorders suggested by NIDA and NIAAA. 

Inquiries

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

Scientific/Research Contacts:

Jeffrey D. Schulden, MD
Medical Officer
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5147, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 402-1526
Fax: 301-443-2636
Email: schuldenj@nida.nih.gov

Rosalind Breslow, PhD, MPH, RD
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2081, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 594-6231
Fax: 301-443-8614
Email: rbreslow@mail.nih.gov

Financial/Grants Management Contacts:

Heidi Young
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD  20892-9541
Telephone:  703-243-5024
Fax:  301-594-6849
Email: youngh@nida.nih.gov

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3021
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Fax: 301-443-8991
Email: jfox@mail.nih.gov


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