NIH GUIDE, Volume 21, Number 44, December 11, 1992

PA NUMBER:  PA-93-27

P.T. 34



  Drugs/Drug Abuse 

  Social Psychology 

National Institute on Drug Abuse


The purpose of this Program Announcement (PA) is to encourage the study

of psychotherapy, behavior therapy, drug abuse counseling, and other

psychosocial interventions in the treatment of drug abuse and

dependence.  Studies involving the use of controlled clinical trials or

other scientifically established research methods are encouraged.  A

secondary aim is to encourage the development of instruments to measure

the process and outcome of psychotherapy/counseling of drug addicts and

instruments that may be useful in determining therapist and patient

characteristics predictive of treatment outcome.  This announcement is

intended to encourage the investigation of the treatment of individuals

who are dependent upon cocaine, opiates, and other types of drugs

(including polydrug abusers).  This announcement is not intended to

support therapy development research.


The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of Healthy People 2000, a

PHS-led national activity for setting priority areas.  This PA,

Psychotherapy, Behavior Therapy, and Counseling in Drug Dependence

Treatment, is related to the priority area of alcohol and other drugs.

Potential applicants may obtain a copy of Healthy People 2000 (Full

Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).


Applications may be submitted by foreign and domestic, for-profit and

non-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal government.

Applications from minority individuals and women are encouraged.

Foreign applicants are not eligible for First Independent Research

Support and Transition (FIRST) awards (R29).


Support mechanisms include:  research projects (R01), small grants

(R03), and FIRST awards (R29).  Most investigator-initiated research is

supported by regular research grants.  Research grants are awarded to

institutions on behalf of Principal Investigators who have designed and

will direct a specific project or set of projects.  Except for small

grants (R03) and FIRST awards (R29), investigator(s) may apply for a

renewal (competing continuation) of the project by submitting an

application for further support, including a report of progress and

including specific plans for future work.  For details on a particular

support mechanism or program, contact the program staff listed under




Some form of psychotherapy, behavior therapy, or drug abuse counseling

occurs in virtually every type of drug abuse/dependence treatment.

Even where effective pharmacological treatments exist, such as the use

of methadone for opiate dependence, they are usually administered with

appropriate psychosocial/behavioral interventions (Grabowski et al.,


Numerous behavioral interventions have been studied in attempts to

improve the efficacy of drug abuse treatment.  Contingency management

has been shown to have some efficacy in medically withdrawing patients

from methadone (Higgins et al., 1986) for some methadone-maintained

individuals, but not all (Stitzer et al., 1986; Iguchi et al., 1988;

Stitzer et al., 1992).  Where the methadone dose has been decreased as

a consequence to drug positive urine specimens, treatment dropout has

been exacerbated (Stitzer et al., 1986; Iguchi et al., 1988).  While it

has been suggested that the use of "negative incentives" increases

dropout rate, the extent to which the observed increases in dropout

rate are due to methadone dose reduction per se has not been


Operant behavioral interventions appear to be most effective when

integrated into a complete treatment package, as in the Community

Reinforcement Approach (Hunt & Azrin, 1973; Azrin, 1976).  This

approach, originally developed for alcoholics, has been modified for

cocaine abusers and has shown promise (Higgins et al., 1991).

Behavioral interventions based upon principles of classical

conditioning, such as cue exposure, are also believed to have promise.

When used as an adjunct to a comprehensive outpatient cocaine treatment

program, patients given repeated cue exposure (to induce "extinction"

to cocaine-related cues) evidenced better retention in treatment and

fewer cocaine-positive urine specimens than patients not receiving the

cue exposure (Childress, et al., 1992).

Individual cognitive-behavioral and psychodynamic as well as family

approaches have all been demonstrated to have some efficacy (Stanton et

al., 1982; Woody et al., 1983, 1987; Rounsaville et al., 1983; Carroll

et al., 1991), but none has been demonstrated consistently to be more

effective than another.  This is congruent with findings in the

psychotherapy research field at large; that is, it has not been

consistently demonstrated that one type of psychotherapy is more

effective than another (Luborsky et al., 1975; Smith & Glass 1977;

Lambert et al., 1986; Stiles et al., 1986).

For particular subgroups of patients, however, there is reason to

believe that particular types of therapies may be more useful than

others.  For example, there is some evidence that a structured,

behavioral therapy may be more effective for substance abusers with

sociopathic characteristics than an interactionally focused therapy

(Kadden et al., 1989).  In subgroups of patients with antisocial

personality disorder who have an additional diagnosis of depression,

cognitive-behavioral and supportive-expressive psychotherapy appears to

be of some benefit.  However, antisocial personality disorder alone

appears to be a negative indicator for response to psychotherapy (Woody

et al., 1985).  There is also some evidence that the addition of

psychotherapy to drug abuse counseling may be necessary for other

subgroups of addicts.  For example, in a methadone-maintenance program,

drug abuse counseling is a sufficient complement to the treatment of

opiate addicts with low levels of psychiatric severity.  Providing

psychotherapy to low psychiatric severity methadone-maintained opiate

addicts who are already receiving drug abuse counseling does not appear

to yield any further benefit (Woody et al., 1984).  However, in

methadone-maintained opiate addicts with high levels of psychiatric

severity, psychotherapy in addition to drug abuse counseling is

significantly more effective than drug counseling alone (Woody et al.,


Inherent in doing research on psychosocial treatments for drug

dependence are substantial methodological difficulties.  Attrition is

a problem in any form of behavioral treatment research, but especially

so in drug dependence treatment.  While there are numerous statistical

procedures for dealing with the problem of attrition (Howard et al.,

1990), none can replace lost data.  It is, therefore, important to be

aware of the ramifications of utilizing the array of available

statistical techniques that are sometimes used to partially "correct"

for lost data.  Defining and including control groups as opposed to

comparison groups (Borkovec, 1990) also presents a dilemma in

comparative psychosocial treatment research.  While there is no

"perfect" design in such research, there are more or less perfect

designs depending upon the research question we are asking.  Other

methodological and statistical issues, such as those dealing with

therapist/counselor variance (Crits-Christoph et al., 1990) and

choosing appropriate outcome measures (Lambert, 1990) are also

important considerations and have been discussed at length elsewhere

(Onken and Blaine, 1990).

Additional research is needed to answer a number of questions in this

field such as:

1.  Are certain strategies of drug abuse counseling/psychotherapy more

effective than others in helping individuals achieve treatment goals?

2.  In what way are various immediate treatment goals related to

long-term outcome goals?

3.  What is the relative efficacy of drug abuse counseling versus

psychotherapy, and when and with whom is drug abuse counseling


4.  What populations of drug addicts (e.g., the dually diagnosed,

racial and ethnic minorities, women, adolescents, etc.) require what

types of counseling or psychotherapy?

5.  How is the process of psychotherapy or counseling related to

outcome in drug dependence treatment?

6.  What are the characteristics of successful therapists, patients,

and therapist/patient pairs?

Specific Areas of Interest:

1.  Development of Psychotherapy/Counseling Instruments and Research

Methods.  Psychotherapy research, particularly with drug addicts, is in

an early stage of development.  The development and the refinement of

instruments and methods that measure the theoretical constructs in the

fields of psychotherapy and counseling are needed.  Without instruments

that measure these constructs in a valid and reliable manner, the

controlled, scientific study of psychotherapy and counseling is


Investigators are encouraged to develop new instruments and refine

existing instruments from the mental health field that can be used in

controlled psychotherapy/counseling research studies with drug addicts.

The development of valid and reliable instruments that measure various

aspects of the process and strategies of psychotherapy/counseling, the

immediate goals and outcome of these treatments, therapist

characteristics predictive of treatment outcome, and patient

characteristics predictive of outcome are encouraged.

2.  Comparative Psychosocial Treatment Research with Drug Addicts.

Controlled clinical trials that examine the relative efficacy of

psychotherapy, behavior therapy, counseling, pharmacotherapy, and the

many combinations of these forms of treatment with various populations

of drug addicts are encouraged.  The goal of such comparative treatment

research is not to determine which treatments "win," but, rather to

determine which treatments are most efficacious with which populations,

and under what conditions.  Studies that investigate the relative

efficacy of individual, group, or family psychotherapy, behavior

therapy, and drug abuse counseling in patients with various co-morbid

Axis I and Axis II disorders are particularly encouraged.

Investigations that compare the efficacy of one form or combination of

psychotherapy, behavior therapy, or counseling to another in other

subpopulations of drug addicts (e.g., racial and ethnic minorities,

pregnant women, and individuals who abuse cocaine intravenously) are

also encouraged.  Where effective pharmacotherapies are available,

research projects that attempt to maximize the efficacy of that

pharmacotherapy through integration with psychosocial treatment are


Applicants proposing comparative psychosocial treatment research

studies are encouraged to examine the interactions of relevant

therapist/patient characteristics with therapy type and to assess the

relative contribution of therapist, patient, and type of therapy to

treatment outcome.

For these studies, it is imperative that investigators accurately

measure and control for the psychiatric diagnosis and problem severity

level of the patients.  It is also necessary that clear definitions of

treatment outcome variables be specified, and that valid and reliable

measures of outcome be used.  It is recommended that

therapists/counselors providing the treatment be systematically

trained, that manuals be used to guide the treatments, that valid and

reliable therapist competence and adherence scales be used, and that

the treatment process be measured accurately.  For all efficacy

studies, it is recommended that adequate followup assessments be

planned.  It is also important that these studies use procedures and

methods that can be replicated.  It is strongly suggested that pilot

data showing that a counseling or psychotherapy strategy is promising

be provided when proposing comparative research involving this

treatment.  These pilot data should indicate that the utilization of

the therapy approach shows promise in its ability to produce a decrease

in drug use, dropout rate, or psychiatric symptoms.

3.  Research on Therapist and Patient Variables in Psychotherapy and

Counseling.  Researchers have highlighted the importance of individual

differences among therapists and counselors independent of the form of

treatment.  Some studies have shown that certain therapists/counselors

are more successful than others, and that this success is more related

to the treatment provider than to the type of treatment provided (e.g.,

McLellan et al., 1988).  Studies are sought that assess therapist

and/or counselor characteristics and relate these characteristics to

effective treatment.  Studies that examine the interaction of

therapist/counselor and patient variables as related to outcome are

also encouraged.  Additionally, studies that link the characteristics

of patients with successful psychotherapeutic, behavioral, or drug

abuse counseling treatment are desired.  Measurements of therapist and

patient characteristics should be obtained using psychometrically sound

instruments.  These studies should control for the type of treatment

offered and should use objective, empirical measures of the treatment

process that occurs.

4.  Short-Term vs. Long-Term Goals of Drug Abuse

Counseling/Psychotherapy/Behavior Therapy.  The treatment process may

be viewed as having two distinctive but interrelated sets of goals.

One set involves long-term objectives to be achieved as a result of

involvement in the treatment program.  These goals include reduction in

illicit drug use, reduction in illegal activities, improvement in

social adjustment, etc.  The other set of goals involves specific

objectives to be achieved within the treatment program that, it is

assumed, will allow clients to attain the long-term treatment goals.

These immediate goals include assisting the client in recognizing the

harm caused by drug dependence, developing personal strategies for

reducing or avoiding stress, recognizing irrational ideas or beliefs,

developing realistic strategies for interpreting life events, etc.

Research is needed to determine how immediate treatment goals are

related to long-term treatment goals (i.e., how success in achieving

goals within treatment is related to success in achieving goals that

result from treatment).  For example, investigators may wish to

establish different measures of immediate treatment goals, evaluate

clients on success in achieving those goals, and then relate success in

attaining immediate treatment goals to outcome measures of drug use or

social adjustment.  Research is also needed to identify, operationally

define, and compare the efficacy of different strategies for attaining

immediate treatment goals.  For example, investigators may wish to

establish different measures of immediate treatment goals, evaluate

clients on success in achieving those goals, and then relate success in

attaining immediate treatment goals to outcome measures of drug use or

social adjustment.  Also, investigators may wish to establish two

distinctive procedures for achieving stress management (or employment)

by clients and then compare the efficacy of the two procedures in terms

of stress management.  Controlled clinical trials or other rigorous

research methods should be used.

5.  Component Analysis Research.  Knowing the effective components of

treatment can greatly aid in improving the quality of treatment.

Theoretically based research that attempts to determine the effective

components or combination of components in drug dependence

psychotherapies, behavior therapies, or counseling strategies is


Where there is more than one way to answer a proposed research

question, investigators are urged to state their theoretical, ethical,

and practical reasons for choosing one research design over another

(see Borkovec, 1990).  Investigators should address the issues of

selection bias and attrition (Howard et al., 1990), and any other

pertinent methodological issues (see Onken and Blaine, 1990).

If a subject is identified as being at risk for HIV acquisition and/or

transmission, HIV testing and counseling should be offered to the

subject in accordance with current guidelines. Furthermore, in

high-risk populations, investigators are encouraged to assess the

effect of the new therapy on the acquisition/ transmission of

associated infectious disease, including HIV.





NIH policy is that applicants for NIH clinical research grants and

cooperative agreements will be required to include minorities and women

in study populations so that research findings can be of benefit to all

persons at risk of the disease, disorder or condition under study;

special emphasis should be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affect them.  This policy is intended to apply

to males and females of all ages.  If women or minorities are excluded

or inadequately represented in clinical research, particularly in

proposed population-based studies, a clear compelling rationale should

be provided.

The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information should be included in the form PHS 398 in

Sections 1-4 of the Research Plan AND summarized in Section 5, Human


Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However, NIH

recognizes that it may not be feasible or appropriate in all research

projects to include representation of the full array of United States

racial/ethnic minority populations (i.e., Native Americans (including

American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,


The rationale for studies on single minority population groups should

be provided.

For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including


If the required information is not contained within the application,

the application will be returned.

Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.


Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted at the standard application deadlines

as indicated in the application kit.  The receipt dates for

applications for AIDS-related research are found in the PHS 398


Application kits are available at most institutional offices of

sponsored research and may be obtained from the Office of Grant

Inquiries, Division of Research Grants, National Institutes of Health,

Westwood Building, Room 449, Bethesda, MD 20892, telephone (301)

496-7441.  The title and number of the announcement must be typed in

Section 2a on the face page of the application.

FIRST award applications must include at least three sealed letters of

reference attached to the face page of the original application.  FIRST

award applications submitted without the required number of reference

letters will be considered incomplete and will be returned without


The completed original application and five legible copies must be sent

or delivered to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**


Applications will be assigned on the basis of established PHS referral

guidelines.  Applications will be reviewed for scientific and technical

merit by an initial review group in accordance with the standard NIH

peer review procedures.  Following scientific-technical review, the

applications will receive a second-level review by the appropriate

national advisory council.  Small grant applications (R03) do not

receive a second-level review.


Applications will compete for available funds with all other approved

applications assigned to that Institute/Center/Division.  The following

will be considered in making funding decisions:

o  Scientific and technical merit of the proposed project as determined

by peer review

o  Availability of funds

o  Institute program needs and balance


Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applications is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Lisa Onken

Treatment Research Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-30

Rockville, MD  20857

Telephone:  (301) 443-4060

Direct inquiries regarding fiscal matters to:

Mrs. Shirley Denney, Chief

Grants Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 8A-54

Rockville, MD  20857

Telephone:  (301) 443-6710


This program is described in the Catalog of Federal Domestic Assistance

No. 93.279.  Awards are made under authorization of the Public Health

Service Act, Section 301 and administered under PHS grants policies and

Federal Regulations at Title 42 CFR Part 52, Grants for Research

Projects, Title 45 CFR part 74 and 92, Administration of Grants, and 45

CFR Part 46, Protection of Human Subjects.  Title 42 CFR Part 2,

Confidentiality of Alcohol and Drug Abuse Patient Records, may also be

applicable to these awards.  This program is not subject to the

intergovernmental review requirements of Executive Order 12372 or

Health Systems Agency review.

Sections of the Code of Federal Regulations are available in booklet

form from the U.S. Government Printing Office.

Awards must be administered in accordance with the PHS Grants Policy

Statement, (rev. 10/90), which is available from institutional offices

of sponsored research.


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Childress, A.R., Ehrman, R., McLellan, A.T., and O'Brien, C.P., "Cue

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Higgins, S.T., Stitzer, M.L., Bigelow, G.E. and Liebson, I.A.,

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Higgins, S.T., Delaney, D.D., Budney, A.J., Bickel, W.K., Hughes, J.R.,

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