Notice Number: NOT-DA-14-005

Update: The following update relating to this announcement has been issued:

• May 8, 2014 - Notice to Extend the Response Date for the NOT-DA-14-005 "Request for Information (RFI). See Notice NOT-DA-14-010.

Key Dates
Release Date: March 11, 2014
Response Date: May 1, 2014

Related Announcements
None

Issued by
National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)

Purpose

The National Institute on Drug Abuse and the National Cancer Institute seek information about the availability of data and biological samples from randomized controlled trials of smoking cessation therapies.

Background

Despite a significant reduction in the number of people who smoke, smoking continues to be a leading cause of premature death in the United States. Forty-four million Americans continue to smoke with 440,000 premature deaths occurring each year. Eighty percent of those who attempted to quit on their own, without pharmacological or behavioral therapies, relapsed within the first month, with only 3% still abstinent at 6 months. Only 15 to 35% of individuals remain abstinent for a year with pharmacological interventions such as nicotine replacement therapy (NRT), bupropion, and varenicline.

Recent findings suggest that nicotinic receptor subunit risk variants in the CHRNA5/A3/B4 cluster within the chromosome 15q25 locus are associated with failed quit attempts; delay in quitting; early cancer diagnosis than non-risk allele counterparts. Many of these risk variants are more prevalent in European Americans and rarer in African Americans, which may have implications for the generalizability to a larger ethnically diverse population. Based on the nicotine metabolite ratio (NMR) along with CYP2A6 genotype, smokers can be categorized into slow and fast metabolizer categories. Slow metabolizers receive little benefit from pharmacotherapies like bupropion, while NRT’s like the patch offer suitable cessation aides. Conversely, fast nicotine metabolizers seem to receive good benefit from varenicline.

Personalized medicine strategies to treat nicotine addiction based on these findings may now help to increase the effectiveness of existing pharmacotherapies. Still questions remain on whether the results for the CHRNA5/A3/B4 cluster variants, CYP2A6 variants, and NMR biomarker can be moved to the clinic. Genetic analysis from other smoking cessation trials is needed to validate these results in different population. Samples from existing clinical trials are needed to conduct whole genome wide association analysis to identify other gene variants that are predictors of smoking cessation response to pharmacotherapies and/or those susceptible to the deleterious consequences of smoking, such as lung disease, cancer, and heart disease.

Information Requested

The National Institute on Drug Abuse and the National Cancer Institute seek information about the availability of data and/or biological samples from randomized controlled trials of smoking cessation therapies. If you have conducted a randomized clinical trial, we request that you send information about the clinical trial. Examples of the type of information that would be helpful include: 1) The Program Director/Principal Investigator and Assistant contact information; 2) publication and or clinical trial registry IDs; 3) the number of trial participants randomized with data available for intent-to-treat analysis; 4) the types of bio-specimens available and the number of research participants with these bio-specimens 5) the number of bio-specimens or DNA samples with data available for intent-to-treat analyses; 6) amount of DNA available per research participant; 7) trial design characteristics; 8) Baseline demographics and behavior; 9) trial Sponsors

The information gathered will assist in evaluating the feasibility of combining data and samples for a pharmacogenomics analysis of smoking cessation based on the availability of these samples.

Submitting a Response

All responses must be submitted via email to smokingcessation@nih.gov by May 1, 2014. Please include the Notice number in the subject line. Response to this RFI is voluntary. Responders are free to address any or all of the categories listed above. The submitted information will be reviewed by the NIH staff.

This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.

The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may be aggregated in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Inquiries

Please direct all inquiries to:

Jonathan D. Pollock, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1309
Email: jpollock@mail.nih.gov