Funded Projects

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Project #	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s) Sort descending	Location(s)	Year Awarded
3UG1DA040317-05S2 Show Summary	Pharmacists’ knowledge of, attitudes about, and intention to provide pharmacy-based services for screening, brief intervention, and referral to treatment and medication treatment for opioid use disorders	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	Duke University	Wu, Li-Tzy	Durham, NC	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: Given the magnitude of the opioid death epidemic, we need multiple approaches to increase use of medication treatment for opioid use disorder (MOUD) for people from diverse geographical locations. Pharmacists as dispensers of and gatekeepers to opioid medications, including those used for OUD treatment, are natural partners of health care providers. Community pharmacists are widely available even in rural areas. This 2-year study will use a mixed-method design that includes qualitative and quantitative approaches to study pharmacists’ knowledge of, attitudes about, and intention to provide patient care and services for screening, brief intervention, and referral to treatment for substance use disorders and MOUD. Study aims are to conduct stakeholder interviews, develop a survey instrument to assess such barriers and facilitators, pilot test the survey instrument, and conduct the survey among licensed pharmacists.
3UG1DA040317-05S2 Show Summary	Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080)	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	DUKE UNIVERSITY	WU, LI-TZY T	Durham, NC	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women.
1R21DA056637-01 Show Summary	KCa2 Channel Activators for Opioid Use Disorder	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	University of California, Davis	WULFF, HEIKE	Davis, CA	2022
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R21 Clinical Trial Not Allowed) NOFO Number: RFA-DA-22-032 Summary: Safe and effective options are urgently needed to prevent and treat opioid use disorder and polysubstance use disorders. Previous research in humans and animals suggests that activating the calcium-activated potassium channel KCa2.2 is a promising therapeutic approach for treating substance use disorders and associated health conditions. This project will perform a virtual high-throughput screen using novel machine learning approaches to discover new molecules that interact with the KCa2.2 channel. The newly discovered molecules help develop novel drugs for the treatment of opioid use disorder and associated health conditions.
2R44NS086343-04 Show Summary	IND-ENABLING STUDIES ON NOVEL CAV3 T-CHANNEL MODULATORS FOR TREATMENT OF NEUROPATHIC PAIN	Cross-Cutting Research	Small Business Programs	NINDS	AFASCI, INC.	XIE, XINMIN SIMON	REDWOOD CITY, CA	2018
NOFO Title: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44) NOFO Number: PAR-17-480 Summary: We discovered a class of non-opioid modulators of the T-type Cav3.2 channel that could treat neuropathic pain. In vivo pharmacokinetic and pharmacodynamic studies and preliminary toxicological studies identified AFA-279 and other candidates, which did not produce observable side-effects and showed greater analgesic effects than other neuropathic pain medications in rodent models. The goal of this proposed project is to submit the IND application on our Cav3.2 modulator to the Food and Drug Administration (FDA). We will produce AFA-279 under Good Manufacturing Practice (GMP)–like conditions using chemical manufacturing controls for Good Laboratory Practice (GLP) nonclinical toxicity studies and GMP clinical batch future Phase 1 clinical trials, complete toxicological and safety studies to establish the safety profile of AFA-279, prepare and submit the IND application, and then initiate early clinical trials. Our ultimate goal is to deliver a safer, more effective, non-opioid Cav3.2 channel modulator to patients suffering from neuropathic pain.
1UG3DA048768-01A1 Show Summary	Novel LAAM formulations to treat Opioid Use Disorder	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	Virginia Commonwealth University	Xu, Qingguo	Richmond, VA	2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional) NOFO Number: RFA-DA-19-002 Summary: Levo-alpha-acetylmethadol (LAAM) offers numerous behavioral and clinical advantages for select opioid use disorder (OUD) patients who do not respond to standard treatment. While LAAM was withdrawn from the market despite being approved for OUD treatment, this project seeks to develop novel, patentable, convenient dosage forms of LAAM, including novel LAAM oral dosage formulations and novel buccal film formulations of LAAM. Morphology, mechanical property, drug release kinetics, and stability of the oral dosage and buccal film formulations will be characterized to determine the instant release or steady release of LAAM, respectively. The two lead LAAM formulations with adequate release and stability profiles will be chosen through optimization studies both in vitro and in vivo. A human pharmacokinetic/pharmacodynamic study will then be carried out on the two selected formulations.