ROLE OF TOBACCO DEPENDENCE IN ALCOHOLISM TREATMENT

RELEASE DATE:  February 14, 2002

PA NUMBER:  PA-02-064

EXPIRATION DATE:  February 5, 2005 unless reissued.

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
o References

PURPOSE OF THIS PA

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking 
research grant applications to study the alcohol tobacco interaction in its 
implications for alcoholism treatment. The objective of this program 
announcement is to encourage research that will lead to improved strategies 
for treating alcohol and nicotine dependence in patients receiving care for 
problem drinking. Such research may identify and test relevant clinical 
intervention strategies; identify interactions between the two substances 
that have implications for relapse prevention, or further understanding of 
the alcoholism treatment process by investigating reinforcement mechanisms 
underlying conjoint abuse of the two substances. 

RESEARCH OBJECTIVES

During the past decade many lines of converging data have suggested that 
alcohol and tobacco consumption are correlated. For example, smokers consume 
two times as much alcohol per capita as do non-smokers (Carmody et al., 1985) 
and their risk of excessive drinking is also twice that of non-smokers, a 
relationship that holds across a broad range of demographic variables 
(Henningfield et al., 1990; Johnson and Jennison, 1992). Alcoholism itself is 
estimated as 10 to 14 times more prevalent among those who smoke than those 
who do not (DiFranza and Guerrera, 1990). In addition, heavy drinking tends 
to be associated with heavy smoking with 85 percent of currently drinking 
alcoholics smoking daily. Although smoking has substantially declined in the 
United States to approximately 30 percent of adults, it has diminished very 
little among alcoholics. 

Co-occurrence of smoking and excessive drinking has important treatment 
implications. For example, previous or current problems with alcohol and 
alcohol treatment bodes negatively for success in smoking cessation (Bobo et 
al., 1987; DiFranza and Guerrera, 1990; Sandor, 1991). On the other hand, 
smoking cessation prior to formal alcoholism treatment (Miller et al., 1983) 
appears to improve subsequent drinking outcome. Conversely, reducing drinking 
appears to improve the prospects for successful smoking cessation (Burling et 
al., 1982). Curiously, participation in a stop-smoking program conducted 
during the course of alcoholism treatment was found to enhance maintenance of 
sobriety, even though the intervention had little impact on smoking behavior 
itself (Burling et al., 1991). 

Discontinuation of smoking and long-term abstinence from drinking are also 
associated. Alcoholics who maintain sobriety longer have been reported as 
more successful in smoking cessation (Bobo et al., 1987; Hughes, 1993). 
Similarly, relapse to drinking may prompt smoking relapse (Shiffman et al., 
1985; Sees and Clark, 1993). 

Several pharmacologic and behavioral mechanisms have been proposed to explain 
the association between smoking and drinking. At a pharmacologic level some 
degree of cross-tolerance seems to occur between nicotine and alcohol as 
sympathetic nervous system agents, each of which has both depressant and 
stimulant effects. Second, conjoint use of the two substances may also be due 
to accelerated metabolism of one substance following ingestion of the other. 
Third, nicotine and alcohol may somewhat counteract the aversive effects of 
each other, while potentiating reinforcing effects. 

Specific Areas of Interest

The following list of topics is intended only to illustrate NIAAA interests; 
topics not specified should not be viewed as excluded from consideration. The 
primary objective of this program announcement is to enhance the efficacy of 
treatment for nicotine dependent, alcohol-dependent patients. To that end, 
research studies are solicited in the following areas. 

Research is needed to determine the conditions under which tobacco use serves 
as a salient risk factor for alcohol relapse. 

Research suggests several hypothesized mechanisms for the linkage in conjoint 
alcohol-tobacco use. Studies are needed to more clearly specify these 
putative mechanisms and understand their interactions. 

Studies are needed which identify the optimal sequencing of alcohol and 
smoking cessation in treatment programs. 

Studies are needed which investigate the use of new/existing pharmacologic 
agents as adjuncts to alcohol and smoking cessation and in the maintenance 
of abstinence. 

Research is needed which elucidates factors that underlie the joint 
vulnerability to alcohol and nicotine dependence. 

Research is needed to develop common assessment methodologies for alcohol and 
tobacco dependence which will lead to improved treatment efficacy. 

Studies are needed which clarify the nature of the discriminative stimuli for 
alcohol and nicotine and how these stimuli interact. 

Studies are needed to determine whether conditioned cues associated with 
smoking enhance alcohol reinforcement. 

MECHANISM(S) OF SUPPORT 

This PA will use the NIH research project grant (R01) small grant (R03) and 
Exploratory/developmental grant (R21) award mechanism.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project. The total project period for a research project grant (R01) 
application submitted in response to this Program Announcement may not exceed 
5 years.  Exploratory/developmental grants (R21) are limited to 3 years for 
up to $100,000/year for direct costs. (See Program Announcement PA-99-131, 
"NIAAA Exploratory/Developmental Grant Program," 
http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html, for a complete 
description of the R21 mechanism.)    

Under the NIAAA Small Grant mechanism (R03) applicants may request either 
$25,000 or $50,000 in direct costs per year for up to two years.  These 
awards are not renewable; however, a no-cost extension
of up to one year may be granted to the grantee institution prior to 
expiration of the project period. Before completion of the R03, investigators 
are encouraged to seek continuing support for research through a research 
project grant (R01).  (See Program Announcement PA-99-098, "NIAAA Small Grant 
Program," http://grants.nih.gov/grants/guide/pa-files/PAR-99-098.html, for a 
complete description of the R03 mechanism.)

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats 
(see http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, 
if you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.
 
WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research, and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Joanne B. Fertig, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulvard, Suite 505 MSC 7003
Bethesda, MD  20892-7003
For express mail use:
Rockville, MD  20852)
Telephone:  (301) 443-0635
Fax:  (301) 443-8774
Email:  jfertig@NIAAA.nih.gov

o Direct your questions about financial or grants management matters to:

Judy Fox Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulvard, Suite 505 MSC 7003
Bethesda, MD  20892-7003
(For express mail use:
Rockville, MD  20852)
Telephone:  (301) 43-2434
Email:  jsimons@niaaa.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email:  GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIAAA staff member who has agreed to 
accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
	
1)	Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will not 
accept any application in response to this PA that is essentially the same as 
one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board
	
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider 
alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OTHER REVIEW CRITERIA:  

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998:  http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of 
clinical research; updated racial and ethnic categories in compliance with 
the new OMB standards; clarification of language governing NIH-defined Phase 
III clinical trials consistent with the new PHS Form 398; and updated roles 
and responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.273, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

REFERENCES

Burling, T.A., Marshall, G.D. & Seidner, A.L. (1991).  Smoking cessation for 
substance abuse inpatients.  J Subst Abuse, 3(3), 269-276.

Burling, T.A., Stitzer, M.L., Bigelow, G.E. & Russ, N.W. (1982).  Techniques 
used by smokers during contingency motivated smoking reduction.  Addict 
Behav, 7(4), 397-401.

Carmody, T.P., Brischetto, C.S., Matarazzo, J.D., O'Donnell, R.P. & Connor, 
W.E. (1985).  Co-occurrent use of cigarettes, alcohol, and coffee in healthy, 
community-living men and women.  Health Psychol, 4(4), 323-335.

DiFranza, J.R. & Guerrera, M.P. (1990).  Alcoholism and smoking.  J Stud 
Alcohol, 51(2), 130-135.

Henningfield, J.E. Clayton, R. & Pollin, W. (1990).  Involvement of tobacco 
in alcoholism and illicit drug use.  Br J Addict, 85(2), 279-291.

Hughes, J.R. & Oliveto, A.H. (1993).  Coffee and alcohol intake as predictors 
of smoking cessation an tobacco withdrawal.  J Subst Abuse, 5(3), 305-310.

Johnson, K.A. & Jennison, K.M. (1992).  The drinking-smoking syndrome and 
social context.  Int J Addict 27(7), 749-792.

Sees, K.L. & Clark, H.W. (1993).  When to begin smoking cessation in 
substance abusers.  J Subst Abuse Treat, 10(2), 189-195.


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