Funded Projects

Lumbar spinal surgery, an increasingly common surgery in adults with severe chronic back pain, is associated with acute post-surgical pain, costly postoperative opioid-related adverse effects, long hospital stays, high-risk for chronic post-surgical back pain, and persistent opioid use and dependence. Each individual responds differently to opioids based on their unique genetic and clinical factors, and the current trial-and-error approach to opioid use and prescribing promotes excessive opioid use, costly adverse outcomes, and poor surgical pain management. To address this issue, this research project will develop a preoperative diagnostic test that will use genetic and clinical information to proactively assess each person’s risk for opioid-related adverse events and chronic post-operative pain. The results will help clinicians provide personalized pain management to maximize pain relief while minimizing opioid-related safety risks, including opioid dependence.

Most people with opioid use disorder are either not in treatment or receive inconsistent treatment. Peer support is proven to be effective at engaging patients who are unwilling or unable to seek traditional treatment, but commonly available group support models are often separate from other clinical care or are otherwise hard for patients to access. This research will test a novel, machine learning enabled, digital peer support program added to an anonymous text-based social network that can provide 24/7 support for patients at all stages of recovery. The project will examine the ability of this digital service to engage and retain patients with opioid use disorder and will also develop novel techniques to automatically analyze patient messages for clinical and social determinants of health-related needs.

Relapse is common in people with opioid use disorder, and recovery attempts often fail within 6 months. This research project will test a novel virtual reality intervention to improve recovery outcomes for people recovering from opioid use disorder. By increasing future orientation and delay-of-reward behavior with a precision medicine personalized experience, the intervention is designed to enhance advantageous decision-making and increase positive future outcomes. The results of this study will provide critical data for creating a commercially viable software product for facilitating relapse prevention and improving opioid use disorder recovery outcomes.

Neuropathic pain adversely affects quality of life and remains challenging to treat, presenting high unmet medical need. One example of this type of pain, chemotherapy-induced peripheral neuropathy, is a chronic, severely debilitating consequence of cancer therapy for which there are no effective treatment strategies. This research is testing a new cannabidiol (CBD) analogue (KLS-13019) with neuroprotective properties and which has improved drug-like properties compared to CBD. This project will optimize the process to manufacture KLS-13019, develop analytical methods, optimize its formulation, evaluate its safety and toxicity, and test KLS-13019’s efficacy of in a rat model of chemotherapy-induced peripheral neuropathy.

There are alarming rates of substance abuse and diversion in hospitals, with multiple studies finding that roughly 10% of our nation’s nurses, anesthesiologists, and pharmacists are currently diverting drugs in their workplaces. Diversion continues even though most hospitals already lock addictive drugs in Automated Dispensing Machines (ADMs) and run monthly “anomalous usage” computer reports to try to detect diversion. This SBIR project will research mechanisms to detect when health care workers (HCWs) in hospitals steal or “divert” legal drugs, either to abuse themselves or to illegally sell to others, by building a computer system with (a) automated data feeds from multiple existing hospital computer systems and (b) advanced analytics to flag potential diversion for investigation. This research has the potential to reduce injuries to HCWs who are becoming addicted, destroying their careers, jeopardizing their patients’ safety, and increasingly dying from drug diversion overdoses.

Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-­based application, miDOT, for office-­based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.

Adolescents face increased HIV risk, infrequent testing, inconsistent linkage to care, and a lack of prevention-related knowledge. We propose to complete and evaluate the Mobile Augmented Screening (MAS) tool to privately and discretely offer routine HIV testing and counseling, including prevention education, to high-need, diverse adolescent and young adult populations at a low cost. The MAS will consist of a tablet-based intervention including a brief video designed to increase adolescent HIV testing, automated text messages to facilitate linkage to care for those who test positive, and text-based education for those who test negative or decline testing. Phase I was conducted with young emergency department (ED) patients. Preliminary evaluations indicate the video led to significant knowledge increases and encouraged testing. In phase II, we seek to complete intervention development and evaluate through a randomized controlled trial with ED patients, with qualitative interviews for a subset of young patients and ED staff.

Migraines and other headaches are often debilitating for patients, yet few treatment options providing sustained relief exist. All available therapies, including frequently prescribed opioids, have considerable side effects or limitations. Therefore, novel treatment approaches are needed to reduce or eliminate the need to use opiates and other systemic pharmaceuticals. Thermaquil Inc. has developed a new way of stopping migraine and other headache pain by noninvasively blocking pain signal transmission in the head, which in initial studies allowed patients to discontinue use of opioids and other addictive pain medications. Thermaquil will now be conducting a larger randomized controlled trial to demonstrate the safety and effectiveness of this novel approach. After a baseline period, patients will be randomly assigned to the active or control condition and receive a single treatment. The study will continue for 12 weeks with the active versus control arms, before all patients will be given active therapy for an additional 12 weeks.

Osteoarthritis is one of the most common joint diseases affecting Americans. Osteoarthritis is particularly high among veterans with a service-related disability. This project will develop and refine a wireless ultrasound device that increases the penetration of over-the-counter pain medications into the body, which is expected to reduce pain. The research will conduct safety and clinical testing toward commercializing this technology. 

Reversing an opioid overdose requires a rapid response not available through standard emergency procedures. The Opioid Rapid Response System recruits and trains citizen responders to reverse overdoses with naloxone. It uses widely disseminated smart phone apps linking responders to an overdose through the 911 system. This project will complete the development of this system, test how well it works to reverse an opioid overdose, and prepare to share it widely. 

Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction, giving them a central role at the crossroads of chronic pain and the opioid crisis. Blocking chemokines (rather than opioid receptors) provides an exciting treatment opportunity for both pain and opioid use disorder. This research continues previous work studying the efficacy of RAP-103, a small, orally stable chemokine receptor blocker. The previous research has shown that RAP-103 is safety and effective in preclinical models that mimic human drug-taking. This research will now optimize the dose required to achieve decreased motivation to maintain opioid use, establish manufacturing scale-up feasibility, provide RAP-103 for safety testing in animals, and conduct stability testing of RAP-103 toward the goal of submitting an Investigational New Drug application to the FDA.