Notice of Participation of the National Institute on Drug Abuse (NIDA) in PAR-07-024, Ancillary Studies to Major Ongoing NIDDK and NHLBI Clinical Research Studies (R01)

Notice Number: NOT-DA-09-005

Key Dates
Release Date: February 11, 2009

Issued by
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)

This notice announces the participation of the National Institute on Drug Abuse (NIDA) in PAR-07-024, “Ancillary Studies to Major Ongoing NIDDK and NHLBI Clinical Research Studies (R01)” (http://grants.nih.gov/grants/guide/pa-files/PAR-07-024.html).

The following Institutes continue to participate in PAR-07-024: 

All other aspects of this FOA remain unchanged.

Overview:  Through this notice, the National Institute on Drug Abuse (NIDA) encourages investigators to propose ancillary studies to NIDDK’s Longitudinal Assessment of Bariatric Surgery (LABS, http://www.niddklabs.org) to assess substance use disorders and other high risk behaviors among persons who have undergone bariatric surgery.  Ancillary studies in support of 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 which 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 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 substance abuse and other high risk behaviors 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 was initially funded in 2003 as a five-year cooperative agreement.  A limited competition for renewal, to be funded in July 2009, is expected to provide an additional five years of funding. Over 2,400 persons are projected to be enrolled in the longitudinal follow-up component of the study.  Teen-LABS was initially funded in 2006, also as a five-year cooperative agreement.  Approximately 150-200 adolescents are expected to enroll for pre-op evaluation and two year 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 Proposals:  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 substance use and other high risk/addictive behaviors in the LABS and Teen-LABS cohorts (including supplemental analytic proposals) or ancillary proposals for new studies on substance use and other high risk/addictive behaviors.  Current LABS/Teen-LABS investigators and those investigators who are not currently affiliated with LABS/Teen-LABS are eligible to apply.  All proposal 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.  Proposals 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-07-024.html). 

Inquiries

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

NIDA Scientific/Research Contact:

Jeffrey D. Schulden, MD
Medical Officer
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5153, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 402-1526
Fax: 301-443-2636
Email: schuldenj@nida.nih.gov

 

NIDA Financial/Grants Management Contact:
Pam Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD  20892-9541
Telephone:  301-443-6710
Fax:  301-594-6849
Email: pfleming@nida.nih.gov


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