Pilot Award for Utility of Biomarkers in Substance Abuse Research

Project Award Amount $30,000 Maximum

Description

This funding is intended to support projects focused on any area of substance abuse, with the expectation that the awardee will make use of analytical chemistry support, study design, and/or data analysis and interpretation offered by the Clinical Pharmacology Research Laboratory (CPRL), the funding agency. CPRL is supported by a P30 grant from the National Institutes on Drug Abuse (NIDA). Applications in any aspect of basic research, including novel analytical chemistry methods for drugs of abuse and/or their metabolites in bio samples, clinical research or translational research directly related to drugs of abuse will be considered. Analytical chemistry support through the CPRL may be for quantification of abused or treatment drugs or biomarkers. Analytical methods currently available are in the table below; feel free to inquire about others not listed.

Analytical Methods Available for Biofluid Samples and Other Sample Types

Analyte(s)

Method

LLOQs

Nicotine and metabolite cotinine

GC

1, 10 ng/mL

Nicotine (high sensitivity)

GC-MS/MS

0.2 ng/mL

Cotinine and trans-3’-hydroxycotinine, nicotine metabolite ratio

LC-MS/MS

0.02 ng/mL

Multiple nicotine metabolites in urine (total nicotine equivalents)

LC-MS/MS

1-10 ng/mL

NNAL, tobacco carcinogen biomarker

LC-MS/MS

0.00025 ng/mL

Nicotelline, biomarker for tobacco smoke particulate matter

LC-MS/MS

0.003 ng/mL

Minor tobacco alkaloids – validate smoking cessation during nicotine replacement therapy or e-cigarette use

LC-MS/MS

0.002-0.02 ng/mL

Polycyclic aromatic hydrocarbon (PAH) metabolites - carcinogens

LC-MS/MS

0.01-0.5 ng/mL

Mercapturic acids (VOC biomarkers)

LC-MS/MS

0.1-5 ng/mL

THC and 11-hydroxy-THC in plasma; THC acid metabolite in urine

LC-MS/MS

0.2 ng/mL

Bupropion and metabolites – tobacco cessation medication

LC-MS/MS

1 ng/mL

Varenicline - tobacco cessation medication

LC-MS/MS

0.1 ng/mL

Cocaine and metabolite benzoylecgonine

LC-MS/MS

1 ng/mL

Methamphetamine and amphetamine

GC-MS

0.1-2 ng/mL

MDMA and MDA

GC-MS

1-5 ng/mL

Gamma hydroxybutyrate (GHB) and butanediol (BD)

GC-MS

1000 ng/mL

Methadone and metabolite

GC

5 ng/mL

Buprenorphine

LC-MS/MS

0.1 ng/mL

Caffeine and metabolites

LC-MS/MS

10 ng/mL

LLOQ is lower limit of quantitation

Each pilot project will have a maximum budget of $30,000. Pilot projects are for one year and are not renewable. A progress report is required at the end of the funding period, identifying resulting publications and subsequent funding obtained to support the expanded/extended projects. Any resulting publication must directly acknowledge acknowledge the (CPRL), and or NIDA?

Eligibility

Eligibility requirement need to be met as of date of submission, no waivers will be accepted.

Who's Eligible:

UCSF Faculty in any series (Ladder Rank, In Residence, Clinical X, Health Science Clinical, Adjunct) in all ranks (Instructors, Assistant, Associate, Full Professors) and Appointees to the Professional Research Series and to the Librarian Series may apply.

Who's Not Eligible:

Residents, Fellows and Postdocs, Specialists.

Submission Rules

Criteria for Review/Evaluation of Applications

We encourage the submission of innovative projects focused on any aspect of drugs of abuse, particularly those in which biomarkers will be utilized. Proposals will be evaluated based on the quality of the proposed scientific investigation, the significance of the proposed research for the field of substance abuse research and, the potential of the proposal to lead to future successful NIH grant applications, and the quality and promise of the applicant and the research team.

Pilot projects that involve human subjects will require human research committee approval before funding is released.

Selection of Awardees

Funding decisions are made independently by each funding agency based on several factors – scientific review score, alignment of proposal to funder’s strategic goals, proposal research area of focus, and specifically called out eligibility or other requirements like membership in a center, affiliation with a specific school or relevance to a stated auxiliary topic.

TO APPLY:

STEP 1) Complete the electronic application form.  Please note there are several pieces of information that need to be provided directly via the electronic application form (selecting the appropriate grant mechanism, providing demographic information, uploading an abstract, etc.).

Click here to preview an inactive template of the electronic application form.

STEP 2) Upload your proposal as a SINGLE PDF that includes all the things listed in numeric order in the instructions below.


INSTRUCTIONS FOR PROPOSAL PDF

Please write your proposal following the instructions listed below and create one single PDF file. Do not include form fields in your PDF document.

Proposal Length: Maximum 6 pages, including figures and tables, excluding table of contents and literature cited.
Format Requirements: Arial font; 11 pt; minimum 0.5 inch for all margins; no appendices; include page numbers and table of contents.

RESUBMISSIONS
Definition: Same research topic with an amended application or research plan rather than a new research topic and new research plan.
Requirements: Please use up to one extra page to introduce your revised proposal, addressing the issues raised in the review, and any additional changes to your proposal. Make sure the new edits are highlighted in bold or italic font so the reviewers can easily see where and how the proposal has changed. Do not use "track changes". A new letter of support from the Department Chair or other Unit Head is required in all cases.

1. P.I. Name(s) - Optionally, you may apply with two PIs. If funded, PI1 will be the primary contact for the award set up and management. If the proposal has multiple PIs, both PI1 and PI2 need to meet the eligibility criteria listed for this grant mechanism. Only ONE application as PI (PI1 or PI2) is permitted per cycle.

2. Project Title

3. Proposal (maximum 6 pages, including figures and tables, excluding literature cited)

  • Aims. Do not submit an application that describes an idea that is the same or similar to one used in a previously funded RAP grant. If it is a similar idea, describe how the new proposed research is uniquely different.
  • Feasibility: Describe what steps you are taking to ensure the proposed project can be completed within the one-year project period for this grant (approximately 300-word max).
  • Background and Significance
  • Preliminary studies
  • Experimental Design and Methods (include time-table)
  • Explain how this pilot project is important for your career goals (e.g., lead to major funding, etc.)
  • Literature cited (not included in page limit)

4. Detailed Budget $30,000 maximum per proposal; round up to the nearest thousand (i.e. instead of $29,869 list $30,000).

Use the following form: PHS 398 Form Page 4, "Detailed Budget for the Initial Period":
http://grants.nih.gov/grants/funding/phs398/phs398.html 

    Budget Preparation Resources:
    OSR: Develop a Budget 
    Standard Budget Components, including information on personnel costs (salary and benefits)
    NIH: Develop Your Budget

 

Allowable

Not Allowable

PI Salary *

     X

 

Co-Investigator(s) Salary

     X

 

Post Doc Salary

     X

 

Network Recharge Rates      X  

Administrative Support

 

X

Supplies

     X

 

Equipment

     X

 

Software

 

X

Personal Computers

 

X

Mailing

 

X

Tuition

 

X

Travel

 

X

Research Staff Support (e.g. SRA; Lab. Technician)

 

 

Patient Care

 

X

International Subcontracts

 

X

Indirect costs on subcontracts

 

X

General Guidelines:
*The NIH base salary cap applies.  PIs are required to list their effort whether it is paid or in kind.

PI partial salary support should be well-justified with respect to project activities. Due to their small size, RAP grants are designed for project support and are not intended to provide PI salary support unrelated to the project.  PI salary amounts greater than ~10% of the requested award amount (e.g., $5,000 of a $50K award proposal, not 10% FTE) must be well justified and it should reflect work done by the PI to conduct specific scientific tasks on the project (e.g. data collection, computation) and not merely general supervision of project goals and personnel.

Multiple PIs can decide how to distribute the 10% salary support among themselves (e.g., 5%/5% or 6%/4%).

  • The 10% limit on salary support is a guideline and includes SALARY & FRINGE BENEFITS.
  • Update: General Automobile and Employee Liability (GAEL) are NOT allowable costs.
  • The award amount is DIRECT COST ONLY

5. Budget Justification: Clearly and fully justify all costs.
For all personnel, clearly identify any discrepancies between the actual effort (i.e. real percent time) the individual will contribute to the project, versus the amount of salary effort they are requesting.  This is particularly important for personnel/PI's who expect to contribute project effort with little or no salary, such as those whose salary is above the NIH base salary cap.

Recall: PI salary amounts greater than ~10% of the requested award amount must be well justified

6. NIH Bio-sketch of Principal Investigator(s) and Co-Investigator(s) and UCSF Faculty Mentor(s) (if applicable) (5 page maximum):
Use this version: Biosketch Version F. Include bio sketches for all PIs of a multi-PI application, and any other key personnel such as Co-Investigator(s) or UCSF Faculty Mentor(s). In section "D. Additional Information", list the relevant recent past, planned, active, and pending proposals, including percent effort and total direct costs (annual), where possible. Include a brief discussion of any potential overlap with the current proposal. 

7. Letter(s) of support: Provide a letter of support from the department chair or other unit head. In addition, for early career investigators, department chairs/unit heads should comment on the independence of the applicant and availability of research space and other resources for the proposed research. Include the letter of support at the end of your PDF proposal and address it to the RAP Committee. If there are multiple (two) PIs, a letter of support is required for both PIs. If PIs are in the same department, the chair can vouch for both PIs in a single letter.