Active clinical trials for "Opioid-Related Disorders"

This study aims to investigate pain management and satisfaction following orthognathic surgery, which is a type of surgery that corrects jaw and facial bone issues. This type of surgery can result in significant post-operative pain for participants, and the goal of this study is to find a way to manage this pain in a more effective and safe manner. The study will focus on the use of opioid pain medication and will compare two groups: one group will receive a standardized prescription plan. In contrast, the other group will receive a personalized prescription with a plan to taper the opioid medication. In the end, any unused opioid will be compared at the end of the 7-day post-discharge period between the two groups. This is important because excessive opioid prescription can either be diverted to the community or can be misused leading to opioid use disorders. Data will be collected from pre-surgery appointments, during the surgery and hospital stay, and follow-up appointments. The data collected will include participants' demographics, medical history, type of surgery, and information about the pain medication used. The study hypothesizes that the personalized prescription plan will result in less unused medication and higher satisfaction with pain management compared to the standardized prescription plan. The study will also stratify the participants into single-jaw surgery and double-jaw surgery groups to evaluate if any differences in the outcomes are observed. This study will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery. Furthermore, this study will also benefit society by providing insights into addressing the opioid crisis that is currently affecting many communities across North America.

This project aims to elucidate the brain effects of opioid use disorder (OUD) treatments. The study will investigate the cognitive effects of extended-release preparations of a partial opioid agonist and an antagonist. To this end, the study will use up to three monthly injections of buprenorphine (XRBUP, Brixadi®) and naltrexone (XRNTX, Vivitrol®). Domain-specific brain activity will be induced by cognitive tasks and recorded with Magnetic Resonance Imaging. Participants will be imaged at baseline and in the interval between the 1st and 2nd injection and followed for up to three months.

This is a pragmatic, open label, randomized controlled trial with 1:1:1 allocation to 12 weeks of: (1) onsite yoga at opioid treatment programs (OTPs), (2) onsite physical therapy (PT) at OTPs, or (3) treatment as usual (TAU). Participants will be 345 individuals with chronic back pain receiving treatment for opioid use disorder (OUD) in community-based OTPs. Through research visits at screening, baseline, and months 1, 2, 3, 6, and 9, the investigators will evaluate pain and opioid use outcomes and implementation outcomes.

The primary purpose of this study is to assess the target occupancy at kappa and mu opioid receptors in the brain after single oral doses of CVL-354 in healthy adult participants.

Knee osteoarthritis is a major issue worldwide with limited treatment options. Many patients receive knee joint replacement surgery which is considered effective and safe. Nonetheless the period post-surgery is characterized by moderate to severe pain inhibiting early ambulation, motivation and range of motion, compromising rehabilitation, patient satisfaction, and overall outcomes. An optimal strategy of postoperative pain treatment after knee replacement surgery has not yet been established. Recently, our research center and others have shown that is possible to target the nerves surrounding the knee with a novel treatment called cryoneurolysis. Cryoneurolysis apply low temperatures [-20°C ; -100°C] to a target nerve, which disrupts nerve function and provides potential pain relief. This suggest a potential for cryoneurolysis to significantly improve rehabilitation, reduce opioid intake and overall outcomes after knee replacement surgery. The primary objective of the current project is to determine the effectiveness of cryoneurolysis in its proposed ability to reduce opioid intake and postoperative pain after knee replacement surgery. The study is a randomized controlled study with two groups. Group CRYO receives cryoneurolysis prior to knee replacement surgery and group SHAM receives a sham treatment prior to knee replacement surgery. Both groups receive surgery, analgesics and postoperative rehabilitation as per usual. Efficacy of treatment is evaluated using the change in opioid intake in the CRYO group compared to the SHAM group 14 days after knee replacement surgery. Participants will also be assessed at 90 and 180 days after knee replacement surgery and will include measures on pain, quality of life and function.

The overarching goal of this project is to increase the availability of OUD treatment in rural counties in the state of Georgia by using Emergency Department (ED)-based telehealth strategies to initiate MOUD and connect patients to treatment. The investigators will implement a novel collaboration between rural EDs, medical toxicologists at the Georgia Poison Center (GPC), peer recovery coaches (PRCs) and RCOs throughout Georgia to bridge the gap between OUD treatment need in rural EDs and specialty physician availability at the GPC. Research activities will be conducted during two broad phases, at three rural EDs in Georgia: planning and implementation. During the planning phase, aggregate data will be obtained to determine each ED's existing practices treating patients with OUD and opioid withdrawal. During the implementation phase, the researchers will prospectively study a poison center OUD consultation and PRC intervention as it is rolled out at each site, collecting participant-level data. Sites will be rolled into the implementation phase in a stepped-wedge fashion, so there will be times when some sites are in the planning phase while others are in the implementation phase.

This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up. The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects. The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.

This is a prospective, randomized clinical trial of 316 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce illicit opioid use and pain interference (Aim 1) and decrease alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise [Wii Fit, Tai Chi] and stress reduction [relaxation training, auricular acupuncture] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response illicit opioid use, alcohol use, pain interference, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).

Millions of people in the US misuse opioids each year, leading to thousands of deaths and costing billions of dollars in total economic burden. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This STTR Fast Track proposal is designed to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care. To accomplish these aims, the project will enhance the Opioid Addiction Recovery Support (OARS), an existing Q2i company technology, with a new evidence-based reward, contingency management (CM) function. CM interventions systematically reward (reinforce) specific behaviors like treatment initiation and adherence with therapy attendance and drug-free urine tests and are highly efficacious. An OARS solution enhanced with a CM component (OARSCM) that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of treatment behaviors may be key to improving Suboxone initiation and adherence. In Phase 1 of this proposal, the existing OARS clinician portal and patient mobile application will be modified to accommodate entry into the software system from an acute care setting and to automatically manage and deliver rewards to create OARSCM using patient-centered design principles. Focus groups with OUD patients and other key stakeholders will inform design. Primary usability outcomes will be examined, and the program iteratively updated. After meeting milestones, there was a proof-of-concept pilot of usability, acceptability, and effects on initial behavior targets with approximately 20 patients and at least 4 providers. After meeting milestones, this RCT will follow, in which acute care OUD patients appropriate for outpatient Suboxone (N = 102) are recruited and allocated to one of two study conditions: 1) treatment as usual (TAU) with MyMAT, comprised of screening, brief intervention, referral to treatment by a trained clinician, and an educational mobile app (MyMAT), 2) OARSCM. The active intervention window for the two intervention groups will be 12 weeks. Patients will be onboarded prior to discharge from acute care. In the outpatient Suboxone setting, data on treatment adherence and opioid use will be captured from clinical records for six months. Telephone follow-up assessments and vital statics registry reviews will be at month 1, month 3 (end-of-study intervention period), and month 6. Primary Suboxone treatment initiation outcomes will be completing the Suboxone intake. Primary Suboxone treatment outcomes will be sustained abstinence at Month 6 and longest duration of abstinence. Analysis will examine data on cost avoidance and cost savings through reduced acute care visits between study conditions.

Methadone is a very long-acting opiate very difficult to detox from. In Spain there are a lot of methadone dependent people in the aftermath of the heroin epidemic of the 1980s. Many have been dependent for more than 15 years and a number of them have a relatively stable life condition (have work, family, housing, etc.) and a relatively good health condition in comparison with current heroin users. This Phase-II RCT is a collaboration with the Sant Joan Hospital in Reus, Spain. Twenty patients on the methadone maintenance program will be recruited. Patients will be randomized to two groups: One receiving 6 doses of 100 mg of ibogaine; and the other one receiving ascending doses of ibogaine (100-200-300-400-500-600). Methadone use will be interrupted and for both groups ibogaine will be administered when clinical symptoms of opioid withdrawal appear. After an ibogaine dose, when symptoms of opioid withdrawal appear again, half of the methadone dose used last time will be administered. By doing so, methadone doses will be progressively reduced until no withdrawal symptoms appear.