Opioid Use Clinical Trials

This study seeks to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1-2 level lumbar laminectomy. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures. Read Less

This study will adapt and scale existing AHRQ-supported interoperable CDS for patient-centered chronic pain care. The objective of this project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in primary care clinical settings. The central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making. Read Less

Over one-quarter of American adults engage in hazardous drinking (i.e., a pattern of alcohol consumption that increases risk for harmful consequences), which is the third leading cause of preventable death in the U.S. Rates of hazardous drinking are significantly higher among individuals with (vs. without) chronic pain. Moreover, 20% of individuals prescribed opioids endorse concurrent alcohol and opioid use, which may interfere with chronic pain treatment and lead to dangerous/potentially fatal health effects. No interventions to date have targeted either hazardous drinking or concurrent use of alcohol and opioids in the context of chronic pain. The current four-year R01 builds upon our past work by developing a brief, single-session, computer-based, personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse pain-alcohol-opioid interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding concurrent use of alcohol and prescription opioid medications. Specifically, we will develop an integrated PFI for hazardous drinkers with chronic pain who are prescribed opioids (PA-PFI). Our approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral interventions. Phase IA activities will involve collecting qualitative and quantitative feedback from three iterative focus groups (N = 21) to refine intervention content and evaluate treatment acceptability and feasibility. Phase IB activities will include a proof-of-concept and highly rigorous randomized clinical trial designed to compare PA-PFI to control PFI (C-PFI) among a sample of 174 hazardous drinkers with chronic pain who are currently prescribed opioid medications. This study represents an important and pivotal step in the larger landscape of translating basic research to more efficacious strategies for reducing hazardous drinking among underserved populations with medical comorbidities. This intervention would be highly disseminable and relevant to millions of hazardous drinkers with chronic pain. Given the collective public health impact of chronic pain, hazardous drinking, and concurrent alcohol-prescription opioid use, we believe the current study will yield findings that enhance scientific knowledge, enhance our understanding of mechanisms in reciprocal pain-alcohol-opioid relations, and inform the development of novel treatments for hazardous drinkers with chronic pain that are adaptable and easily implemented across a variety of healthcare settings. Read Less

The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion surgery. tAN is placed on and around the ear to non-invasively stimulate branches of the vagus and trigeminal nerves and modulate specific brain regions associated with pain. Read Less

The study is a quasi-experimental investigation of a sub-acute stabilization center (SASC) for people who have had or are at risk for having an opioid overdose and have an encounter with Seattle Fire Department emergency medical services (EMS) in Seattle, WA. Those transported to the SASC are the intervention participants and two comparison groups will be utilized: eligible Seattle EMS patients who opt not to go to the SASC and King County residents, outside of Seattle, who meet the same eligibility criteria. A comparative interrupted time series analysis is planned to study the main effectiveness outcomes. Seattle Fire EMS will assess, refer, and arrange transport for participants to the SASC. The SASC will offer an array of services including post-overdose monitoring, utilization of buprenorphine and methadone for the treatment opioid use disorder and opioid withdrawal, linkage to ongoing care for OUD, and provision of harm reduction services and supplies. The length of stay in the SASC will be limited to less than 24 hours. A continuous process improvement (CPI) approach will monitor and refine the intervention. Characterization of the interventions will be based upon analysis of service utilization patterns over time along with interviews and surveys with stakeholders. Read Less

The goal of this clinical trial is to determine the effects of an app to reduce opioid and cocaine use when layered atop methadone treatment as usual among people using both opioids and cocaine. The main questions it aims to answer are: * Do people who use the app remain in methadone treatment longer than people who receive only treatment as usual? * Do people who use the app report using opioids and/or cocaine less often, and do they report better improvements in their quality of life, than people who receive only treatment as usual? * Does using the app more lead to better methadone treatment outcomes among people using the app? Participants in this study will be randomly assigned to receive either the app or methadone treatment as usual. Participants randomly assigned to the treatment as usual group will receive access to methadone services as normally provided, including scheduled access to medications, information about the consequences of opioid and other drug use, and any onsite services (including group based interventions and/or 12-step programs). Those randomized into the app-using group will receive all the same services as the treatment as usual group, but will also be given a phone with the app already installed, or will have the app installed on their existing phone if they already have one. At random times throughout the week, the app will ask participants to submit drug tests for opioids and cocaine, which participants will be able to do remotely without having to physically "go to" a testing site. For each test that demonstrates the participant hasn't used opioids or cocaine, the participant will be rewarded with money directly into a debit card. Participants will also be able to earn rewards for picking up treatment-related medications, attending onsite appointments, and other treatment-related activities. Read Less

The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post anesthesia block among patients undergoing total knee arthroplasty. The main question it aims to answer is: 1. Is there a difference in opioid consumption 24-48 hours post block administration among patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)? Participants will be: * Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal catheter. * Asked to use the Diagnotes application to communicate with the pain doctor while the catheter is in place. * Follow up for up to 6 months post-operation. Researchers will compare the interventional group (ACC) to the control group (sham ACC + ACB) to see if there is difference in opioid consumption and chronic pain at 6 months post-operation. Read Less

An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain. Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen. Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Trauma surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence. If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed. Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen. Read Less

The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston. Read Less

In a recent study, researchers let patients choose what medications to go home with after endocrine surgery. This has not been done in outpatient breast surgery, though several institutions have moved towards avoiding opioids altogether after breast surgery. These institutions only prescribed rescue opioids upon request. The aim of this study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids) for outpatient breast surgery. This study will be designed as a randomized, controlled trial. When adult patients consent for outpatient breast surgery, the patients will be asked to participate in the study. Patients who are currently using narcotics would be excluded. The investigators would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested. The investigators will assess patient pain scores and medication use in the recovery area using the electronic medical record. The investigators will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. The investigators will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, the investigators will track their opioid consumption. Read Less

Patients who undergo cardiothoracic surgery often experience pain and anxiety around the time of surgery. Currently, treatments for pain and anxiety around the time of surgery include opioids and benzodiazepines, which can have severe side effects and can be ineffective. Interventions combining virtual reality with olfactory stimuli are a promising alternative to opioids and benzodiazepines in the treatment of pain and anxiety around the time of surgery. The aim of this study is to evaluate the feasibility of a virtual reality and olfactory stimuli multimodal intervention in patients undergoing cardiothoracic surgery. In addition, the investigators will evaluate the preliminary effects of the VR/OS intervention on patient pain and anxiety before and after cardiothoracic surgery. Patients who meet study inclusion criteria and are undergoing cardiothoracic surgery may participate in this study. Patients have an equal being assigned to undergo the virtual reality and olfactory stimuli intervention or continue getting usual medical care with their doctor. If the patient is assigned to receive the virtual reality and olfactory stimuli intervention, the first therapy session will take place approximately two to four weeks before surgery. This will involve wearing a virtual reality headset and scented necklace for approximately 10 minutes. The second session will occur 90 minutes before the surgery. Additionally, for each day the patient recovers in the hospital after surgery, the patient will receive one session in the afternoon. During the patient's in-hospital recovery at night, they will receive lavender scented therapy. Read Less

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur. Read Less