Funded Projects

Researchers at the University of Alabama at Birmingham and the University of Alabama will enroll pregnant women during their second trimester and follow their infants through a comprehensive longitudinal study. This program will follow 300 mother-infant pairs to understand how early life exposure to drugs and other environmental factors affects developmental trajectories. In addition, this program will determine how genetic and biological factors interact with environmental factors to influence neurodevelopment. This study will take place at the University of Alabama at Birmingham, recruiting participants from mainly rural populations with low access to obstetric/gynecological (OB/GYN) care and high rates of substance use.

Little is known about what motivates people to use multiple drugs. Understanding these factors is important for tailoring treatment services. Behavioral economic theory, which determines how much value individuals assign to drugs and potential negative consequences, provides a framework to understand the choices people make. This project will identify patterns, motivating factors, and long-term trajectories of opioid-involved polysubstance use behaviors and treatment. This research will use a range of methods to analyze substance use episodes as well as examine motives and preferences associated with polysubstance use behaviors and how they change over time. The findings will be combined into a toolkit to inform timing, type, and tailoring of interventions and policies to guide implementation of effective clinical strategies and policies for managing polysubstance use in healthcare systems.

This study will assess the implementation of an evidence-based treatment in correctional settings by comparing the effectiveness of two medications used to treat opioid use disorder—extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX)—among adults currently incarcerated in U.S. jails and prisons at five distinct trial sites. This study will allow providers, correctional and public health authorities, payers, and policymakers’ timely and relevant data to assess the effectiveness of these medications as potentially useful re-entry treatment options. Findings from this study have implications for expanding public safety and limiting the societal costs of heroin, fentanyl, and prescription opioid addictions.

Inpatient programs are important portals for increasing access to treatment. However, most individuals with opioid use disorder are detoxified but not offered medications to prevent relapse. This randomized-controlled trial will examine whether a rapid-transition protocol to inducting extended release naltrexone (XR-NTX) following detoxification yields a higher proportion of patients successfully receiving the first injection of XR-NTX compared with standard detoxification and naltrexone initiation. This study will also assess facilitators and barriers to implementing rapid XR-NTX initiation. The overall goal is to foster widespread adoption of a five- to seven-day protocol for initiation of treatment with XR-NTX at inpatient/residential programs.

Overdose fatality review teams review cases of overdose deaths to identify system gaps and innovative prevention and intervention strategies. With the rise in overdose deaths, these multidisciplinary teams require more timely population-level data to inform their recommendations. This project will develop the Overdose Touchpoints Dashboard that uses real-time data and records from multiple sources to help visualize common “overdose touchpoints” for harm reduction services and treatment opportunities. This research will compare use of the dashboard to standard overdose fatality review practices. The project will assess multiple aspects related to use of the dashboard, including process, staff attitudes, implementation successes, and usability.

Current drug-screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians without access to in-house testing have to send out patient samples for screening, resulting in unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. This project, a partnership with BreviTest Technologies, LLC, aims to develop a low-cost, point-of-care (POC) urine drug testing (UDT) device to detect opioids. The goal is for a portable platform to deliver quantitative performance similar to a standard laboratory test for opioids within a 10-minute run time. If successful, this will provide a technology capable of performing rapid quantifications of urine drug levels in a physician’s office, providing an invaluable tool to render more effective pain management dosing to patients, thus paving the way toward lower toxicity and a better quality of life.

Hospital inpatient stays due to opioid-related health problems are a reachable moment for increasing access to treatment with medications for opioid use disorder (MOUD). Hospitalized patients with opioid use disorder (OUD) are at particularly high risk for morbidity, mortality, and high medical costs in the U.S. This study will substantially inform the care management of OUD in hospitalized patients. The project includes a comparative effectiveness research trial and an implementation research trial, which will lead to models of broad dissemination for treatment approaches to this largely unaddressed population. They will examine whether (1) in hospitals with addiction medicine consultation services, hospital-initiated extended-release buprenorphine (XR-BUP), compared with other OUD medications, results in increased engagement in treatment with MOUD following hospital discharge and (2) training hospitals without such consultation services on best practices for initiating MOUD using consultation service hubs improves medication uptake in hospitals and increased MOUD treatment engagement following discharge.

Numerous harm reduction strategies are available to reduce the harmful consequences of drug use. Examples include syringe services programs that provide sterile syringes, easy access to naloxone, and fentanyl test strips that may help people identify whether the substance(s) they plan to take contain fentanyl. This project aims to evaluate the use and effectiveness of several strategies in an urban environment as well as determine the openness and commitment of providers to offering them. 

Millions of Americans undergo surgery each year, with fewer than half of patients reporting adequate postoperative pain relief and approximately 75 percent reporting moderate to severe postoperative pain. Gaps in postoperative pain management that lead to the unnecessary introduction and over-prescription of opioids continue to exacerbate the opioid crisis, but virtual reality (VR) has been demonstrated to be an effective strategy for pain management. This project will enhance and improve the functionality of a VR-based technology, AppliedVR, to provide acute perioperative pain management through a new software-based VR medical device, RelieVRx™. As a non-opioid alternative intended to reduce postoperative pain, RelieVRx can potentially reduce the need for and utilization of opioids in the postoperative setting.

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder (OUD), and overdose, gaps remain between those needing and those receiving prevention and treatment, in part because of a need to better understand how to make these programs and services most effective at a local level. The National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the HEALing Communities Study to generate evidence about how tools for preventing and treating opioid misuse and OUD are most effective at the local level. This multisite implementation research study will test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings. The goal of the study is to reduce opioid-related overdose deaths by 40 percent over three years. The Ohio State University is partnering with academic institutions in three other states to study the impact of these efforts in 67 highly affected communities. The study will also look at the effectiveness of coordinated systems of care designed to increase the number of individuals receiving medication to treat OUD, increase the distribution of naloxone, and reduce high-risk opioid prescribing.

Adolescents in the juvenile justice system demonstrate very high rates of tobacco, alcohol, and other drug use (ATOD), with rates that are estimated to be three times higher than non-justice-involved youth. Substance-abusing youth are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide, as well as detrimental effects on neural development related to substance use. This project aims to adapt and test the feasibility and efficacy of a smartphone application (app) intervention prototype that would help adolescent substance users reduce or quit their substance use. The program, entitled Rewire, is based on the primary substance use cessation components tested in previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation, and applies a mindfulness approach as the guiding framework for the intervention.

Kappa opioid receptors (KOR) are expressed in brain areas that control reward, motivation, and anxiety. Upon opioid drug withdrawal and abstinence, dysregulated KOR signaling can result in aversive physical and affective states that are a major driver of relapse. Preclinical data have demonstrated that antagonism of KOR can reduce the physical symptoms of opioid withdrawal. Currently, the alpha 2-adrenergic agonist lofexidine is the only approved therapy for the mitigation of the physical symptoms of opioid withdrawal but it is only modestly effective and can have significant unwanted side effects. Cerevel Therapeutics has identified a novel selective KOR antagonist, CVL-354, with unique properties and good preclinical safety margins. This project will assess this drug in early human safety/pharmacokinetics and occupancy studies. Future studies will then be able to assess efficacy of this drug in acute opioid withdrawal.

New medication treatment approaches are needed to help address the severe epidemic of opioid use disorder (OUD) and opioid overdose deaths in the U.S. Currently available medications, such as methadone, buprenorphine, and extended release injection naltrexone (XR-NTX; trade name: Vivitrol), are highly efficacious, but their effectiveness in practice is limited by poor adherence, with many patients stopping treatment prematurely and relapsing. The goal of this proposal is to develop an innovative long-acting subcutaneous implanted formulation of naltrexone, the O’Neil Long-Acting Naltrexone Implant (OLANI), toward FDA approval. Expected to produce naltrexone blood levels sufficient to block the effects of opioids for 6 months after implant, OLANI circumvents the need for adherence to monthly injections with XR-NTX and could represent an important new addition to the medical armamentarium for treatment of OUD.