NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK

Release Date:  December 18, 1998

P.T.

National Institute on Drug Abuse

The National Institute on Drug Abuse (NIDA) announces its intention to establish
a National Drug Abuse Treatment Clinical Trials Network.  The purpose of this
notice is to give potential applicants time to discuss ideas and to begin to form
collaborations for developing applications.  As envisioned, the Network will be
funded through a cooperative agreement mechanism, which requires substantial
involvement of NIDA staff in programmatic activities.  NIDA has set aside $10.0
million total costs for funding in FY99.  This level of support is dependent on
the receipt of a sufficient number and diversity of applications of high
scientific merit.  It is expected that approximately four awards will be made in
1999, with additional sites added in successive years.

Background:  Research has provided substantial evidence in support of the concept
that drug addiction is, in many cases, a chronic relapsing disease. As is the
case for other chronic disorders, effective treatments for addiction exist. 
However, again as is the case for other illnesses, the treatment of addiction can
be improved; considerable research has been directed towards that effort in the
past.

The improvement of existing treatments and development of new treatments based
upon findings in basic behavioral and neurobiological sciences are important
national research goals.  In recent years this research effort has yielded a
number of promising new behavioral treatment approaches.  However, the efficacy
of these new treatments has been demonstrated primarily in specialized treatment
research settings, with somewhat restricted patient populations.  As a
consequence, few of these new treatments are being applied on a wide-scale basis
in real-life practice settings.  Research is needed to validate new science-based
treatments for drug abuse and addiction across a variety of community-based
treatment settings and with diverse patient populations and to implement or adapt
these treatments in community-based practice.

For medications, the situation is somewhat different.  Only three medications
have been approved by the Food and Drug Administration (FDA) for the treatment
of opiate addiction: methadone, LAAM, and naltrexone.  There are no approved
medications for the treatment of cocaine, methamphetamine, or marijuana abuse and
addiction.  Thus, the range of options available for the use of medications to
treat drug addiction is quite limited.  However, NIDA-supported researchers have
now tested an array of both new and existing medications for specific
applications, and some are now ready for clinical trials in community settings.
The engagement and participation of community-based treatment providers in large-
scale clinical trials of potential therapeutic agents is essential for full and
appropriate testing and to ensure the acceptability and availability of agents
after FDA approval.

As in other fields of medicine, providers in the area of drug abuse and addiction
are often slow to adopt new treatments.  This can be due to such factors as
inadequate dissemination strategies, organizational or funding constraints, or
resistance to change on the part of management or staff.  Transporting treatments
from research to practice is itself an important research area that has too often
been ignored in clinical research. 

Thus, NIDA intends to establish The National Drug Abuse Treatment Clinical Trials
Network (CTN) to meet two major needs:  First, a research infrastructure is
needed to test the effectiveness and usefulness of new and improved treatments
in real-life settings with diverse patient populations.  Second, a mechanism is
needed for the systematic study of processes and factors involved in the
incorporation of new and improved interventions into community-based drug
treatment.

The National Drug Abuse Treatment Clinical Trials Network:  The CTN is expected
to forge partnerships among NIDA, treatment researchers and community-based
treatment providers in order to improve the quality of drug abuse treatment
throughout the nation, thereby reducing the prevalence, morbidity and mortality
of drug abuse and addiction.  Establishment of strong partnerships between
researchers and practitioners is essential to assure that new treatments address
the critical needs of community-based treatment programs and are suitable for
those settings.  Through this joint effort, the gaps in current treatment
approaches will be addressed, yielding community-proven treatments ready for
adoption into clinical practice.

It is expected that, under this CTN, each awardee will function as a CTN Research
Node, consisting of a Regional Research and Training Center (RRTC) that is linked
in partnership with community-based treatment programs (CTPs).  The CTN will
consist of multiple Nodes, and each Node will work in concert with other Nodes
and NIDA to conduct multisite and cross-regional (nationwide) clinical trials
research.  Awardees will deliver and test an array of both behavioral and
pharmacological treatments and determine conditions under which novel treatments
are successfully adopted.  Most studies to be conducted will span multiple sites,
populations and geographic regions.  It is expected that CTPs will be full
partners in decision making about research directions and activities, as forging
new bi-directional models of cooperation is central to the success of the CTN. 
Because of the complexity of the proposed research and need for collaboration,
principal investigators should be able to document a substantial history of
managing complex research initiatives in clinical sites and have an extensive
publication record in clinical research. 

As a cooperative agreement, there will be substantial NIDA involvement in the
management and administration of the CTN, including in the determination of which
trials will be implemented using components of the Network.

Investigators who may wish to apply under the upcoming initiative are strongly
encouraged to begin discussions with colleagues in research and community-based
treatment settings in order to develop a strategy for preparing the application. 
Because it is expected that applications will need to present a strategy for
organizing a Regional Node that will eventually work with other Regional Nodes,
considerable discussion with potential regional collaborators will be needed in
order to shape a competitive application.

This notice is for information and planning purposes only and shall not be
construed as a solicitation or obligation on the part of the Government to issue
a Request for Applications or to award a grant.

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