U.S. Department of Health and Human Services, National Institutes of Health: Prescription Drug Abuse (R21 Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) encourages applicants to develop innovative research applications on prescription drug abuse, including research to examine the factors contributing to prescription drug abuse; to characterize the adverse medical, mental health and social consequences associated with prescription drug abuse; and to develop effective prevention and service delivery approaches and behavioral and pharmacological treatments.

Specific areas of research interest include, but are not limited to, the following:

Basic and Preclinical:

• Studies using animal models to probe the effects of prescription drugs on neurobiological, neurochemical, and neurobehavioral processes.
• Studies of the pharmacokinetics, pharmacodynamics of drug-drug interactions between abused prescription drugs and other illicit and licit substances (e.g. alcohol, supplements, other prescription medications).
• Studies on the mechanisms of sex differences in opioid analgesia.
• Studies on the mechanisms of transition of acute pain to chronic pain.
• Pharmacogenetic studies examining the critical genes and biological pathways involved in prescription drug abuse to identify and replicate important variation in those pathways and vulnerability to addiction in cells or animals. Applicants exploring this area are encouraged to consult the Notice of NIDA’s Priorities for Human Genetics Research (https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-012.html).

Clinical Pharmacological and Behavioral Research:

• Clinical studies of the pharmacokinetics, pharmacodynamics of drug-drug interactions between abused prescription drugs and other illicit and licit substances (e.g. alcohol, supplements, other prescription medications). Research on age-related physiological changes that may influence the metabolism and response to prescription drugs.
• Studies to determine effective ways to treat chronic pain that do not lead to abuse.
• Research on opioid-induced hyperalgesia and its relationship to tolerance and addiction.
• Development of abuse-deterrent pharmaceutical formations.
• Pharmacogenetic studies examining the critical genes and biological pathways involved in prescription drug abuse to identify and replicate important variation in those pathways and vulnerability to addiction in humans.
• Applicants exploring this area are encouraged to consult the Notice of NIDA’s Priorities for Human Genetics Research (https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-012.html).
• Clinical neuroimaging studies to examine how prescription drugs affect brain processes and systems over the life span.
• Behavioral treatment research on pain reduction, prescription opioid use and abuse among different types of substance abusing populations (including pregnant women, populations with comorbidity of psychiatric disorders, and prisoners).
• Studies that examine risks for transition from therapeutic use to abuse including analgesics, stimulants, sedative/hypnotics and anxiolytics.
• Studies to develop and evaluate behavioral treatments and other treatment strategies for the management of conditions such as pain, anxiety, sleep disorders, and obesity, in people with a history of substance abuse, both with and without comorbid medical or psychiatric illness.
• Studies that leverage web-based tools, cyber-psychological tools (e.g. virtual reality) and/or mobile device platforms to improve treatment research for prescription drug abuse.

Epidemiology and Prevention Research:

• Studies that explore expanded use of naloxone formulations (e.g., injection or intranasal) in health settings and field settings to treat opioid overdose.
• Studies, by class of drug, on the nature and magnitude of prescription drug misuse and diversion from both licit and illicit sources among populations at high risk including chronic pain patients, the military, veterans, older adults, young adults and youth (e.g. stimulant medications for ADHD and extent to which youth misuse and share their own prescription with peers or take these substances to enhance performance).
• Studies on the impact of pregnant women’s prescription drug misuse on their newborns, and development of interventions to address the problem among both pregnant women and their affected offspring.
• Studies on the impact of the introduction of abuse-deterrent pharmaceutical formations on drug use patterns.
• Studies on the nature and magnitude of co-ingestion or mixing of prescription drugs with other substances (e.g., alcohol, marijuana, other prescription drugs).
• Studies to evaluate whether prolonged treatment with prescription psychoactive drugs for conditions such as ADHD, sleep disorders, pain, obesity, and anxiety disorders, contributes to drug abuse, relapse, or cross-sensitization in vulnerable individuals.
• Studies that explore the impact of existing evidence-based drug abuse prevention approaches, or variants of existing approaches, on prescription drug abuse patterns.
• Studies to determine the effectiveness of clinician, workplace, social network, and media driven approaches to risk reduction for vulnerable groups (e.g. military personnel, young adults/college students, etc.)
• Studies to identify best policies and practices for prevention at the local and state levels when responding to regional crises involving prescription drug non-medical use and abuse.

Health Systems Research:

• Research on approaches to screening, assessment, diagnosis, prevention, and treatment for prescription drug abuse in adults and adolescents, especially for use by health professionals in primary care settings (e.g., SBIRT), including research to develop new approaches and to further validate existing models.
• Research on attitudes, knowledge, and patterns of prescribing across categories of patients and health care providers and how these contribute to appropriateness of prescribing practices and disparities in health care (e.g., differential prescribing practices based on socioeconomic status or sex/gender).
• Studies that utilize e-health/electronic health records (EHR) to improve delivery of prevention and health systems research for prescription drug abuse.
• Studies to identify patient populations who are under- or over-medicated or have difficulty obtaining adequate treatment with controlled substances.
• Research in pharmaco-economics to study optimum drug therapy and health outcomes utilizing quality-of-life assessment and outcomes research.
• Evaluations of the impact, validity and cost effectiveness of Prescription Drug Monitoring Plans on recovery and ability to insure safe clinical practice.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 activity code. For example, long-term projects, or projects designed to increase knowledge in a well-established area, are not appropriate for R21 awards. Applications submitted to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Amount: Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed in any single year. The maximum project period is 2 years.

Eligibility: Special district governments; for profit organizations including small businesses; Native American tribal organizations; independent school districts; nonprofit organizations with or without 501(c)(3) status; city or township governments;  institutions of higher education; county governments; public housing authorities/Indian housing authorities; state governments; and others.

Link: https://www.grants.gov/web/grants/view-opportunity.html?oppId=298304

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