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Division of Clinical Neuroscience and Behavioral Research (DCNBR)

Description:

A. Behavioral and Integrative Treatment Branch. The Behavioral and Integrative Treatment Branch is interested in research on behavioral and integrative treatments for drug abuse and addiction. The term "behavioral treatments" is used in a broad sense and includes various forms of psychotherapy, behavior therapy, cognitive therapy, family therapy, couples and marital therapy, group therapy, skills training, meditation, guided imagery, counseling, and rehabilitative therapies. The term, ?Integrative treatments? refers to treatments that combine behavioral interventions with other treatments, including other behavioral therapies, medications, and/or complementary/alternative therapies. Behavioral and integrative treatment research has been conceptualized to consist of three stages. Stage I, or early treatment development, involves research on the development, refinement, and pilot testing of behavioral and integrative interventions. Stage I may include translational research that incorporates concepts, methods or findings from other disciplines (e.g., neuroscience, cognitive science, etc.) into the development of behavioral and integrative treatments. Stage I may also include research to develop or adapt treatments to become more ?community-friendly.? Stage II includes testing treatments that show promise and testing the ?dose-response? of treatments. Stage III is research aimed at determining if and how efficacious behavioral treatments may be transported to community settings. Stage III may include studies that test treatments in community settings, with community therapists. Stage III may also include studies that develop or test methods of training treatment providers to administer treatments. Determination of mechanism of action of treatment is relevant to all three stages. Specific areas of interest include:

1. Translation from Basic Behavioral or Cognitive Science. ?Stage I? research on the development of behavioral therapies or components of such therapies that are based on developments and findings from the basic behavioral or cognitive sciences.

2. Translation of Cognitive, Affective and Social Neuroscience Findings Towards Development of Behavioral Treatments. ?Stage I? research on the development of behavioral treatments or components of such therapies that are based on developments and findings from cognitive, affective, or social neuroscience. For example, one may wish to apply findings on the neural underpinnings of adolescent risk-taking behaviors to target the developmental needs of substance using youth, or apply findings on the link between early adversity and the impairment of emotion regulatory abilities to address the needs of substance using victims of childhood abuse.

3. Treatment of Sleep Disorders for Individuals in Drug Abuse Treatment. Recent research on sleep has shed new light on its importance to psychological and physical health. Sleep deprivation has been linked with impaired cognitive performance, negative mood, and even decreased immune function. Drug abusers often cite insomnia as reason for relapse, and may use drugs to modulate their sleep/waking cycles. However, the treatment of sleep disorders has not been a primary focus of drug abuse treatment research. The development and testing of sleep hygiene interventions, alone or in combination with behavioral interventions, for use in conjunction with drug abuse treatment, as a means of improving treatment for drug abuse is needed. Developmentally and age appropriate, as well as gender sensitive treatment of sleep disorders could impact on the development of more effective treatment interventions.

Lisa Onken, Ph.D.

301-443-2235

Email: l010n@nih.gov

4. Modifying Efficacious Behavioral Treatments to be Community Friendly. Several behavioral interventions have been found to be efficacious for the treatment of drug addiction. However, there are barriers to implementation of behavioral treatments in community-based settings. Community settings that treat drug addicted individuals are reluctant or unwilling to adopt these interventions for a variety of reasons. Reasons that scientifically-based behavioral treatments are not accepted by community providers could include the excessive cost of implementation, the length of time for administration of treatment, inadequate training available for therapists and counselors, treatments not shown to be generalizable for different patient populations or for polydrug abusing populations, etc. Research aimed at modifying efficacious behavioral treatments to make them more acceptable to community settings is needed. Settings might include, drug abuse treatment facilities, primary care, managed care, after-school or classroom settings, colleges, and the criminal and juvenile justice system. Examples of possible studies are those that are designed to reduce the cost of treatments, reduce the time of administration of treatments, aid in training of therapists, counselors and nurses, adapt individual therapies for group situations, etc.

5. Treatments to Prevent Escalation from Abuse to Dependence. Therapies for drug abusers who are not yet dependent on drugs to reduce risk of escalation to dependence and therapies for drug abusers who have not considered or claim little interest in seeking treatment for their drug problems are needed. Treatments for participants in their natural environment, such as treatments delivered over the Internet, cell phone, or in neighborhood settings such as churches and recreation centers are desired. A particular focus on treatments which incorporate engagement strategies for hard to interest groups are requested. Educational games, interactive video content, fluency based learning approaches and other methods to help maintain involvement are encouraged.

6. Virtual Reality Applications for Drug Abuse. Development and improvement of treatments using Virtual Reality and other new simulation technologies is needed. New technology may help to make existing treatments more effective, or may make novel treatments possible. Behavioral treatment research to develop, modify, adapt, and test treatments for drug abuse and for co-morbid psychiatric conditions (such as anxiety disorders) using new technologies is of interest.

Recently virtual reality simulations have been used to train medical personnel in demanding medical procedures such as microsurgery techniques. Virtual training allows trainees to gain familiarity with both the environment in which services are delivered as well as the intervention techniques without the danger of mistakes impacting live patients. Virtual reality interfaces can assess skill acquisition and provide detailed feedback during procedures to help trainees correct mistakes or avoid making them altogether. In the drug abuse field, training and dissemination efforts have been hampered by a dearth of knowledge about ways to conduct dissemination. Although trainees often practice on actual clients, this approach has drawbacks including its reliance on the client or participant?s schedule and willingness to participate in training sessions and potential danger to the client or if the intervention is delivered incorrectly. Libraries of virtual reality simulations of drug users in treatment or ?virtual patients? are needed to provide experiential training for treatment providers without relying on existing patients. This will help facilitate the rapid and effective dissemination of proven treatment strategies.

7. Virtual Clinical Trials Settings for Conducting Behavioral Treatment Trials and Addictions Treatment Provider Education Trials in Cyberspace. Virtual communities such as Second Life as well as private web forums offer a unique opportunity for behavioral therapy researchers and providers to establish and conduct online psychotherapy and behavioral therapy development research as well as a forum to develop provider ?university?s? at which various training techniques may be tested for discovering the most efficacious way to deliver continuing education and other training in the latest methods of treating addiction. Applications are encouraged to develop such a forum and test either a provider training or behavioral therapy method in an online trial. As part of this research platform, methods for obtaining consent, maintaining confidentiality, collecting data and where needed, assessing provider adherence and competence are expected.

8. Remote and/or Mobile Abstinence and Identity Verification. Methods are needed for at home or mobile abstinence verification which include identity verification. Drug abuse treatment researchers are in the process of developing web-based and mobile phone based treatments which can extend treatment beyond the clinic walls. Additionally, there is growing recognition by providers that drug addiction is a chronic disease which may require multiple bouts of treatment. However, currently there are no means of monitoring abstinence once patients leave formal treatment or validating progress of patients undergoing treatment located outside a clinic which provides onsite testing. Monitoring onsite testing poses barriers to patient privacy but unobserved sample donation may be subject to switching and adulterants. Products are needed which both test for the presence of illicit substances and which accurately identify the donor of the sample and the time of its submission so patients can participate in monitoring outside of formal treatment settings. Blood sampling similar in invasiveness to a skin prick for diabetes testing or other low risk sampling of other tissues and specimens may be acceptable. Scalability and automation of methods are particularly desirable.

Cecelia Spitznas, Ph.D.

301-443-0107, Fax: 301-443-6814

Email: cmcnamar@mail.nih.gov

9. Improving Adherence to Medications and Treatment for Drug Abusers with HIV/AIDS. The introduction of highly active antiretroviral therapy (HAART) has significantly changed HIV/AIDS clinical care. There is a need for research related to the development and testing of new and improved behavioral interventions(alone, and in combination with pharmacological treatments for drug addiction), in order to facilitate better adherence to antiviral regimens among drug abusers with HIV infection, including HIV positive drug abusers with comorbid medical illnesses and/or psychiatric disorders. There is also a need to develop and test adherence interventions administered or assisted by technological devices such as computers, the internet, expert system models, telephone pagers, or hand-held computers.

10. Treatment for Emerging or Specific Populations. Therapies designed to intervene with understudied populations including users of drugs such as methamphetamine, MDMA and other club drugs, marijuana, inhalants, and prescription opioids and psychostimulants, as well as children of substance abusers in need of treatment, and drug abusers with comorbid psychiatric disorders and/or medical illnesses such as HIV/AIDS, hepatitis, etc.

11. Development of HIV Risk Reduction Interventions. Research to develop and evaluate behavioral strategies to reduce HIV risk behaviors in HIV-positive and HIV-negative substance abusing treatment populations. Where appropriate, risk reduction interventions should be adapted to patients? age, gender, cultural background and potential cognitive impairments, and should address compliance with medical regimens. The product of such research might be training, supervision, or educational materials, such as manuals or videotapes that describe the intervention and its implementation by treatment staff.

12. Woman and Gender Differences in the Provision of Behavioral Treatments, and HIV/AIDS Risk Reduction Approaches. Develop and evaluate specific behavioral treatment approaches targeting drug-addicted women. This may include behavioral therapies, skills training techniques, counseling strategies, and HIV and other infectious disease behavioral risk reduction strategies. This may also include development and testing of training materials that specifically address women and gender differences in drug addiction treatment to promote effective use of research-based treatment approaches. Training materials may involve treatment manuals, training videos, CD ROM or DVD technologies, Internet or computer based programs to manage aspects of treatment administration, or other innovative educational strategies for health professionals using new technologies.

13. Behavioral Treatments Drawing from Stress Research or Stress-Management Interventions. Projects are encouraged that apply concepts from stress research (such as appraisal, coping, and social support) to drug abuse in innovative ways, or that test the extent to which stress-management interventions can be applied to the treatment of drug abuse and interventions to reduce risk of HIV and other infectious diseases. Examples of stress-management techniques that may have novel application to drug abuse and HIV risk include techniques that teach problem-solving and affect-management, restore one?s sense of purpose and meaning, prevent burnout in the face of chronic stressors, increase self-efficacy for managing stress, inoculate against stressors, train relaxation and meditation, intervene during crises, enlist social support and system support, and others.

14. Behavioral Strategies for Increasing Medication Adherence. Research to develop and to evaluate strategies to induce recovering addicts to take medication for a prolonged time, especially opioid antagonist naltrexone; partial opioid-agonist buprenorphine, etc. to encourage HIV infected drug users to comply with medical treatments (HAART) in drug abuse treatment settings; or to adapt existing behavioral strategies to increase patient compliance and cooperation in long-term treatment for drug abuse or for diseases associated with drug abuse such as tuberculosis or hepatitis. An important consideration should be cost and practicality of use in actual clinical practice or in an aftercare program. The product of such research might be a manual, which describes the behavioral strategy, and its implementation by treatment staff or scientific data regarding evaluation.

Shoshana Kahana, Ph.D.

301-443-2261, Fax: 301-443-6814

Email: kahanas@mail.nih.gov

15. Integration of Behavioral Treatments and Pharmacotherapies. Development of integrated behavioral treatments and pharmacotherapies may enhance the efficacy of both types of therapeutic interventions. For instance, the maintenance and detoxification of heroin addicts could perhaps be optimized by the integration of distinctive behavioral treatments devised specifically for opioid agonists, antagonists or partial agonists determined by the heterogeneity of the subgroup of addicts and the pharmacological differences of the medications. Integration of medications and behavioral treatments could possibly enhance compliance with medication regimens, increase retention allowing pharmacological effects to occur and prevent relapse to drug abuse and addiction.

16. Behavioral Treatment Research for Drug Abuse and Addiction in Primary Care. Recent research has shown that physicians and other clinicians often fail to recognize drug abuse or addiction among their primary care patients. In addition, a significant number of these clinicians reported that they did not know how to intervene with their patients if drug abuse or addiction was suspected. Drug abuse related illnesses and morbidity often occur in adults and may have begun in adolescence. However, very little research has been done to develop or test behavioral treatment approaches or combined pharmacological and behavioral treatments for drug abuse and addiction in primary care settings. The objectives of this initiative are to encourage research on the development and testing of innovative behavioral treatment approaches e.g. screening and brief interventions, use of web-based or mobile technologies used alone or in combination with pharmacological treatments. Other goals of this research initiative are to encourage additional research on the development and validation of culturally sensitive screening and assessment instruments for use with youth and adults in primary care; and to encourage research on the transportability of efficacious behavioral treatments to primary care settings, as well as research on science-based training approaches for changing primary care clinicians' behaviors regarding their recognition and intervention with drug abusing or addicted patients. While motivational enhancement approaches for some drug abusing populations have been found to be effective, this behavioral approach has not been widely used in primary care.

17. Using Telemedicine to Deliver Efficacious Treatment to Underserved Populations in Specialty Addictions Treatment and/or General Medical Settings . Telemedicine programs are being used in urban medical centers to rapidly disseminate science-based information on new medical treatments. In addition, approximately one-third of the rural hospitals are now using telemedicine to improve patient care Studies are needed to modify existing treatments developed by NIDA researchers for deployment and testing as telemedicine treatments at remote locations to underserved populations. These may be delivered in any patient care context including primary care or specialty addiction treatment. Modification of the treatment content to apply to the remote patient population and provider training materials to orient the onsite staff who may not be experienced at delivering the new treatment may be needed.

18. Youth Smoking Cessation. Smoking related illnesses usually occur in adults. However, tobacco use and nicotine addiction generally begin in childhood or adolescence. Despite health warnings, adolescents continue to initiate smoking at alarming rates and the majority will continue to smoke as adults. Adolescents who begin to smoke, develop nicotine dependence very quickly and exhibit withdrawal symptoms during quit attempts in a similar fashion to adults. Most adolescents who smoke, express a desire to quite. To date, research on smoking cessation for teen and young adult smokers has not been particularly fruitful. This initiative requests research aimed at the development and testing of smoking cessation treatments tailored to the specific needs of adolescents and young adults. Consideration should also be given to gender and ethnicity.

19. Complementary and Alternative Medicine Therapies (CAM) for Drug Abuse Treatment. Research is encouraged on complementary and alternative interventions for drug abuse treatment either as the sole treatment or as an adjunct to enhance the therapeutic potency of existing drug abuse treatments. Any of the five CAM categories: Whole medical systems, mind-body interventions, biologically-based therapies, Manipulative/body-based therapies and energy therapies would be considered for this initiative (for more information, see http://nccam.nih.gov/). CAM therapies are interventions that are commonly used in ?real world? settings, but whose therapeutic efficacy has not been scientifically demonstrated. The product of this research might also be a manual or video, which illustrates the intervention and how it is implemented by treatment staff.

Geetha Subramaniam, M.D.

301-435-0974

Email: geetha.subramaniam@nih.gov

20. Developing, Evaluating, and Transporting Culturally Sensitive Behavioral Treatments for Racial and Ethnic Minorities. Minority populations are disproportionately affected by the consequences of drug abuse. Research to develop and evaluate behavioral treatments that are culturally sensitive and relevant for diverse racial and ethnic minority populations is encouraged. This may include studies of behavioral treatments, alone or in combination with pharmacological treatment, or studies of behavioral strategies for increasing adherence to taking medications. In the development and evaluation of the behavioral treatment, attention needs to be directed at examining medical, social, and cultural factors that may influence adherence to the behavioral treatment approach and treatment outcome. Also, little is known about the transportability of efficacious behavioral treatments for minority populations. Research is needed on how to transport science-based treatments to various racial/ethnic populations.

21. Incorporating Smoking Cessation in Drug Abuse Treatment. Research is encouraged to develop and test behavioral and combined behavioral and pharmacological treatments for nicotine-addicted individuals who also are addicted to other substances, such as heroin, cocaine, methamphetamines and alcohol. Prevalence of cigarette smoking is extremely high among drug dependent individuals attending drug treatment. Many treatment providers are reluctant to address smoking cessation with clients either because they believe that substance abusers are not interested in quitting or because they fear smoking treatment will have a negative impact on drug abuse treatment outcome. However, studies have shown that many drug abuse clients are interested in quitting smoking and that the concurrent treatment of tobacco dependence and other drug dependencies does not threaten abstinence and might even assist in maintaining it. Research is needed to develop and test smoking cessation treatments that can be incorporated into treatments for illicit drugs of abuse.

22. Developing Treatments for Smokers with Comorbid Disorders. Research is encouraged that focuses on the development, refinement, and testing of behavioral treatments for smokers with psychiatric comorbidity, such as depression, schizophrenia, or anxiety disorders. Smoking prevalence is very high in individuals with psychiatric disorders. These populations generally respond poorly to traditional smoking cessation treatments. Similarly, medical comorbidities are widely prevalent and are in need of additional research in adults and in special populations such as youth, LGBT and homeless persons. Research is needed to develop and test innovative behavioral and combined behavioral and pharmacological treatments that address the unique needs of these individuals.

23. Tobacco Cessation for Pregnant and Post-Partum Women. Smoking among pregnant women remains an ongoing public health concern. It is estimated that approximately 20-30% of pregnant women smoke. Maternal smoking during pregnancy has been linked to infant mortality, impaired fetal brain and nervous system development, premature and complicated births, and low birth-weight babies. For women who do quit during pregnancy, relapse rates vary, but are reported as approximately 25% before delivery, 50% within four months postpartum, and 70-90% by one year postpartum. Children of smokers continue to be at risk for respiratory illness, middle ear infections, impaired lung function, and Sudden Infant Death Syndrome. Sustained tobacco cessation during pregnancy and the postpartum period reduces health risks to both mothers and their babies. Research focused on the development of innovative behavioral and combined behavioral and pharmacological interventions for nicotine-addicted pregnant and postpartum women is encouraged. Interventions may be tailored to sub-populations of pregnant smokers, such as teenage girls, heavy smokers, ethnic minorities, or low SES populations. Examples of other potential studies may include the development of smoking cessation interventions that address co-occurring issues, such as depression or weight-gain, interventions that include partners or support persons, Internet-based interventions or interventions that can be delivered by primary care physicians.

24 Behavioral Treatments for Groups. This includes the development of new psychotherapy approaches, the modification or testing of existing behavioral treatments, and the design and/or testing of innovative clinical training and supervision methods for dissemination of efficacious treatments to community settings. Examples of relevant projects are: traditional group therapies, such as 12-step and therapeutic community approaches, and newer group therapies such as cognitive-behavioral and acceptance-oriented approaches; groups for various populations, such as adolescents, adults, couple and family groups, gender-specific groups, and groups tailored for racial or ethnic minority populations. Of particular interest are projects that address the recent reports suggesting possible contraindications of group treatments for some populations (e.g., delinquent adolescents), or in some formats (e.g., less-structured, client-led groups).

Debra Grossman, M.A.

301-443-2249

Email: dg79a@nih.gov

25. Developing Behavioral Treatments for Cognitively Impaired Drug Abusers. While there are currently many efficacious interventions available for drug addicted individuals in treatment, more can potentially be done to enhance treatments by addressing cognitive impairments that may accompany chronic drug use and HIV infection. Many commonly utilized drug addiction and HIV-risk reduction interventions assume certain basic cognitive capacities and abilities that may be absent, or impaired, in chronic drug abusers who may also be HIV-positive. For substance abusers to benefit from psychological treatment, they must be capable of attending to and receiving new information, integrating it with existing information stores, and translating this input into more concrete behavioral change. Substance abusers with cognitive limitations, who may not comprehend the interventions, are more likely to drop out of treatment, relapse faster, and have poorer long-term outcomes in comparison to cognitively intact substance abusers. Research is needed to develop, modify, and test ?cognitive-friendly? drug dependence treatments that could lead to improved treatment response and outcome.

26. Interventions to Improve Engagement and Retention in Treatment. Therapies designed specifically to engage and retain individuals in treatment, especially those at high risk for HIV. An example could be a therapy that is: (1) sensitive to the age and motivational level of the client; (2) is specifically designed to respond to the needs of the individual, whatever his or her developmental and motivational level might be; and (3) actively works to increase an individual's desire to remain in treatment.

27. Development of New or Improved Addiction Assessment Measures and Procedures. Research directed at the improvement of a currently available measure or the design of a new psychosocial, social or environmental measure appropriate for use in the clinical assessment of youth and adult substance abusing populations. Special consideration should be given to a specific screening or diagnostic tool, or to a specific measure of treatment readiness, treatment compliance, service utilization, therapeutic process or drug treatment outcome.

28. Marijuana Treatment. Marijuana is the most commonly used illicit substance in the U.S. However, relative to other drugs of abuse, little research has focused on the treatment of marijuana dependence. Trends in the literature suggest that the types of treatments effective with other substances of abuse are likely to be effective with marijuana dependence. Initial studies also suggest that many patients do not show a positive treatment response, indicating that marijuana dependence is not easily treated. Research is needed toward developing and testing effective interventions for marijuana dependent individuals.

29. Transporting Behavioral Treatments to Community Practitioners. There is a need for effective methods of transferring behavioral treatments found to be effective in Stage I clinical trials to clinical practice. Cognitive-behavioral therapy, operant behavioral therapy, group therapy, and family therapy are among the therapies that have been shown to be efficacious in a highly controlled setting and may be helpful treatment approaches in community treatment programs as well. However, community practitioners may have been trained using other approaches and may not have been exposed to these scientifically based approaches. Emphasis should be placed on examining mechanisms to transfer effective research-based drug abuse treatment information and skills-based techniques to practitioners in the community. This may involve the development and testing of innovative training materials and procedures to use in the training of community practitioners to skillfully administer these treatments, including the development of highly innovative technology transfer and communication approaches. Research testing the transportability of empirically supported therapies to the community is an important component of the Behavioral and Integrative Treatment Development Program.

There is also a need for the development of educational methods to train non-drug abuse health care workers in relating to drug abusers; eliciting medical histories regarding past or present drug abuse; recognition of the signs and symptoms of drug abuse; identification of those at high-risk for HIV and other drug abuse related medical problems such as tuberculosis or hepatitis. Development and validation of a drug abuse screening instrument which can be administered by primary health care providers, and training in administering such an instrument is also needed.

Will Aklin, Ph.D.

301-443-3207

Email: aklinwm@mail.nih.gov

30. Treatment Modules for Specific Problems or Populations. Discrete therapy components that address specific problems common among drug addicted individuals and that can be implemented in conjunction with other therapeutic services. For example, an investigator may wish to develop a four session, highly focused, job seeking skills module that can be easily implemented by a wide range of practitioners to effectively increase appropriate job seeking behavior. Other examples include, but are not limited to, modules to engage ambivalent drug dependent individuals in treatment, modules to increase assertiveness in female drug addicts who feel pressured by others to use drugs, modules to improve study skills and pro-social interactions among withdrawn substance abusing adolescents, or to incorporate effective HIV risk reduction techniques.

31. Behavioral Treatments for Pre-Adolescents and Adolescents. Developmentally appropriate behavioral treatments for pre-adolescents and adolescents that incorporate HIV risk reduction counseling as an integral component of the treatment. This includes the development of new, or refinement of existing psychotherapies, behavioral therapies, and counseling (group and/or individual). This also includes the development and testing of manuals as well as other creative, interactive approaches for therapy delivery that may consider different settings for delivery, such as primary care, school-based health programs, juvenile justice settings, etc. Also the behavioral treatments should be culturally and gender sensitive.

32. Behavioral Treatments for Couples and Families. This includes the development of new psychotherapy approaches, the modification or testing of existing behavioral treatments, and the design and/or testing of innovative clinical training and supervision methods for dissemination of efficacious treatments to community settings, for youth and adult substance users. Treatments that target domestic violence or other forms of interpersonal abuse along with substance abuse are encouraged.

33. Innovative Technologies for Drug Abuse Treatment, HIV Risk Reduction, and Training Clinicians. Relevant research would be directed at the development and evaluation of innovative technologies to treat substance abuse, enhance adherence to medications, and/or reduce risk for HIV infection or transmission. Approaches should be capable of being readily incorporated at reasonable cost into various treatment settings. Areas of interest include Internet-based treatment or training programs, CD-ROM technology, audio delivery devices, photo therapeutic instruments, and hand-held computers. Also of interest are creative approaches for disseminating science-based behavioral treatments and for training therapists to use scientifically based treatments for drug abuse and addiction. Such approaches might include Internet-based education, interactive computer programs, telemedicine, etc. Finally, approaches which apply therapies with evidence of efficacy through new media such as web-based platforms, over email, or through chat rooms and bullet boards are also desirable.

Jessica Chambers, Ph.D.

301-443-2237

Email: jcampbel@nida.nih.gov

B. Clinical Neuroscience Research. The Clinical Neuroscience Branch (CNB) supports research on the biological etiology (determining the biological basis for vulnerability to drug abuse and progression to addiction, including studies on individual differences and genetics) and clinical neurobiology of addiction (exploring alterations of the structure and/or function of the human central nervous system following acute or chronic exposure of drugs of abuse), and the neurobiology of development (neurobiological effects of drugs of abuse and addiction during various stages of development and maturation, effects of drug exposure on neurobiological processes, development of methodologies and refinement of techniques used in pediatric neuroimaging). The Branch also supports investigations on the cognitive neuroscience of drug abuse and addiction, the neurobiology of treatment, neuroAIDS, and human pain and analgesia. Areas that may be of interest to small businesses include, but are not limited to:

1. Innovative Technology and Tools for Human Substance Abuse Research. There is a continuing need for the development of methods, tools, and technology that can be used as markers of or interventions for brain, genetic or behavioral (including cognitive and affective) alterations in humans related to the risk, or reliance (etiology) of, effects of, or recovery from substance abuse. NIDA has a strong interest in facilitating the identification and use of cross-disciplinary research tools and materials that can be applied to human research that will advance our understanding drug abuse. NIDA also has a strong interest in promoting the commercial adaptation and widespread availability of discoveries (?tools?) made in the course of interdisciplinary research to better serve its mission.

The term research ?tool" is being used in its broadest sense to embrace the full range of resources that scientists use in the laboratory and clinicians use as therapeutics; therefore, one investigator?s tool may be another's end product. The value of research tools is difficult to assess and varies greatly from one tool to the next and from one situation to the next. Providers and users are likely to differ in their assessments of the value of research tools. Many research and clinical tools are costly to develop and have significant competitive value to the firms that own them.

Of particular interest are methods that could be used to determine the effects of drug abuse/ addiction treatments on neurobiological systems in an attempt to understand the neurobiological processes underlying risk and recovery. Also of interest are methods and tools that can be integrated or expend with brain imaging techniques or other brain-related measures that can be used in human subjects.

Examples include, but are not limited to; Development of stimulus-generating hardware and/or software for use in substance abuse studies, including neurocognitive tasks, presentation of drug-related images for the induction of craving or to probe attentional or affective processes, and ?virtual reality? types of dynamic stimuli important in studies of drug abuse and addiction; Remote and mobile based technologies such as PDA?s, ?smart phones?, or web-based applications for measuring cognitive and affective function in real world environments; Development or implementation of interventions such as trans-cranial or direct current brain stimulation, real-time neurofeedback, or cognitive training; New infomatic tools for primary data analysis or secondary data analysis would also be appropriate;

Another example would be methods or technology related to development of the human central nervous system and how drugs of abuse perturb this process. Developmental studies of these populations presents unique challenges when using neuroimaging technology. The development of novel techniques, or the refinement of existing methods, to provide direct noninvasive measures of brain structure and/or function that are adapted specifically for use in pediatric and adolescent populations is strongly encouraged. Also, neurocognitive and other neurobehavioral tasks for use in these populations, especially where they can be designed to probe underlying neurobiological processes, need to be developed (for developmental issues, contact Cheryl Boyce, Ph.D.).

Steven Grant, Ph.D.

301-443-4877

Email: sgrant@nida.nih.gov

or

Cheryl Boyce, Ph.D.

301-443-4877

Email: cboyce@nida.nih.gov

2. Human Brain Neurochemical and Molecular Imaging. Measurement of brain neurochemistry, neuropharmacology (receptors) and gene expression in humans using non-invasive imaging has lagged behind advances in these areas in pre-clinical research as well as in functional and anatomical neuroimaging in humans. There is a continuing need for development of new ways to measure molecular targets in the human brain. Examples include, but are not limited to novel radioligands for PET and SPECT imaging in human brain for molecular targets (e.g., receptors, intracellular messengers, disease-related proteins), as well as novel methods that use magnetic resonance imaging or other emerging technologies such as optical imaging.. The primary application of these methods will be in basic human research. Ultimately, these measures may also be used as potential biological markers and surrogate endpoints for translational and clinical research, drug discovery and development, and clinical trials. The scope of the projects may encompass pilot or clinical feasibility evaluation in pre-clinical studies, model development, or clinical studies. Alternatively, the focus may be on research and development of new technologies for molecular, neurochemical or neuropharmacological development.

Steven Grant, Ph.D.

301-443-4877

Email: sgrant@nida.nih.gov

3. Neuro-Rehabilitation of Drug-Induced Cognitive Deficiencies. The increased awareness that the brain is capable of substantial plasticity throughout the lifespan has opened the possibility that intervention can be developed alter brain or cognitive function so as to accelerate recovery of brain and cognitive dysfunction. Such interventions encompass both direct interventions of brain function as well as indirect interventions based on cognitive or behavioral principles.

Direct interventions include trans-cranial or direct current brain stimulation, real-time neurofeedback, and deep brain stimulation.

Another complementary approach is based on game technology for ?serious (health-related) rather than purely recreational purposes. Serious games can provide a completely controlled, noninvasive, safe and alternative methodology for a variety of important studies of drug abuse and addiction. By involving a person in an interactive computerized situation, designed to be both entertaining yet directive (i.e., in the sense of covertly shaping desired behaviors via highly flexible and programmable sets of scenarios), altered behaviors can be introduced by pre-programming consequences to counteract and potentially reset undesirable neurobiological and neurobehavioral deficits associated with chronic drug abuse.

Areas of cognitive impairment related to substance abuse that could be enhanced through the use of either direct brain interventions, or ?serious? games include diminished decision-making ability, attention/concentration deficits, attentional biases, lack of cognitive flexibility and problem solving abilities, inability to use feedback to monitor/change behavior, memory impairments,.

Steven Grant, Ph.D.

301-402-1746

Email: sgrant@nida.nih.gov

4. Measurement of Psychosocial Stress in Relation to Substance Abuse. There is the need for development, improvement and/or adaptation of precise and reliable field deployable measurement technologies can detect and quantify an individual?s exposure to psychosocial stress and/or one or more drugs. Ideally, the technology could be scalable from selected samples to full population studies. Comprehensive assessment includes measuring acute/chronic/cumulative exposures to psychosocial stress and/or addictive substances with a high degree of temporal and spatial resolution (i.e., as a person moves through environments), and with a high degree of accuracy and sensitivity to detect meaningful variations in extent of and response to exposure across developmental periods (ranging from prenatal to senescence) and among various population groups. Such technologies may include use of emerging remote and mobile technologies such as PDA?s, ?smart phones?, or web-based applications.

Harold Gordon, Ph.D.

301-443-4877

Email: hr23r@nih.gov

C. Human Development Research. The Behavioral and Brain Development Branch (BBDB) supports a broad research, research training and career development programs directed toward: (1) an increased understanding of how developmental processes and developmental outcomes are affected by drug exposure and related factors; (2) an increased understanding of developmental processes that are relevant to: (a) drug use, abuse, addiction, treatment and relapse, and (b) risk behaviors related to drug abuse and other health conditions that often accompany drug use (e.g., HIV infection, STDs); (3) the use of translational approaches to increase understanding of these developmental processes; and (4) an increase in effective interventions aimed at preventing or ameliorating negative developmental outcomes resulting from exposure to drugs and related factors across diverse populations (e.g. racial/ethnic minority; rural/urban, etc.).

1. Develop Improved Technology for Assessment of Prenatal Drug Exposure and Passive Postnatal Drug Exposure.

a. Develop and refine methods for the detection and quantification of infant exposure to drugs of abuse during pregnancy, including nicotine cocaine, marijuana, opiates, and methamphetamines.

b. Develop and refine methods for the detection and quantification of passive exposure to illicit drugs during infancy and childhood including second and third hand exposure to nicotine, marijuana, or other drugs of abuse.

c. Develop technologies for us in diverse settings (e.g. primary care, emergency rooms, obstetrics/gynecology, etc.) of the assessment of prenatal drug exposure and passive postnatal drug exposure.

Nicolette Borek, Ph.D.,

301-402-0866

Email: nborek@nida.nih.gov

2. Develop Interactive Database Systems on Human Subjects Issues for Use by Drug Abuse Researchers Studying School-Age Children and Adolescents Drug Use. Develop systems to assist investigators in obtaining technical and legal information relevant to involvement of children and adolescents in research on drug abuse. Examples of pertinent situations include tracking long-term health and development of children exposed to drugs during pregnancy, and investigating vulnerability and possible pathways to drug abuse including children in primary care and child care settings, and school-age children and adolescents. Human subject issues addressing family environments, child abuse and domestic violence, and secondary data sources are also of interest. These database systems should address issues such as assent and consent, should provide information on variation in laws and guidelines across jurisdictions, should include the capacity for interactive communication on numerous situations potentially facing clinical research and health care professionals, and should serve as sources of referral for additional assistance.

Nicolette Borek, Ph.D.

301-402-0866

Email: nborek@nida.nih.gov

3. Develop Improved Methods of Neuroimaging to Assess Structural and Functional Status of the Brains of Children and Adolescents Exposed to Drugs. Document the feasibility and accuracy of appropriate and acceptable methods for assessing brain structure and function of children and adolescents, with special attention to any or all of the following groups: those exposed to drugs during pregnancy, those passively exposed during infancy and childhood, This could also include products to improve the tolerability, safety and validity of neuroimaging in children and adolescents, e.g. tools or techniques to reduce head-motion artifacts and image those actively using illicit substances. Documentation should include attention to such matters as technological difficulties and risks, and standardization issues relevant to testing conditions and image analysis.

Karen Sirocco, Ph.D.

301-443-4877

Email: ksirocco@nidal.nih.gov

or

James Bjork, Ph.D.

301-443-3209

Email: jbjork@nida.nih.gov

4. Develop and Refine Methodologies and Clinical Tools for Measurement and Effective Interventions of Developmental Factors and Drug Use Among Children and Adolescents.

a. Research to develop and refine methodologies for drug use detection and quantification which may address issues of acceptability, reliability, and validity of one or more methods for clinical research and practice (e.g., interviews, computerized questionnaires, and biological indicators such as saliva or sweat). Development of web, hardware and software technology tools to enable refined physiological and behavioral assessment of normal and atypical infant and child development which may inform risk and interventions for drug use are also of interest.

Nicolette Borek, Ph.D.

301-402-0866

Email: nborek@nida.nih.gov

b. Research and development of novel, or the enhancement of existing tools to be used in effective preventive or treatment interventions, and information dissemination to or understand drug use and its developmental effects for children, adolescents and their families. These tools might be used by researchers, health professionals and other health care providers, as well as by those in the broader community, including educators, day care providers, family members, etc. These tools must take into account cultural and developmental factor to assure their effectiveness and validity.

Cheryl Anne Boyce, Ph.D.

301-443-4877

Email:

cboyce@mail.nih.gov
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