View clinical trials related to Opioid-Related Disorders.
Filter by:The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment. Importantly, medical devices reviewed by the FDA are cleared (based on safety) rather than approved (based on efficacy), which means the BD did not need to demonstrate efficacy before it became commercially available. As a result, the device was not required to have a sham-controlled trial for FDA clearance and there is no active research, to the investigators' knowledge, that specifically addresses the degree to which opioid withdrawal can be treated through neuromodulation. To rigorously evaluate the efficacy of the BD for treating OUD, the investigators will enroll persons with active OUD, not currently receiving medications for OUD. Participants will be recruited and admitted to the Clinical Research Unit (CRU) for a 2-3 week period. During participants' residential stay, participants will be stabilized for 7-11 days on four times daily morphine (30 mg, SC) and undergo a precipitated withdrawal challenge using the opioid antagonist naloxone, approximately >= 4 days of morphine maintenance. This is a standard practice for the investigators' study and allows the investigators to objectively assess dependence. The BD and study medication will begin following morphine stabilization. Participants will be randomly assigned to one of three conditions (1) active BD with placebo (BD/P), (2) sham BD with lofexidine (SBD/L), or (3) sham BD and placebo (SBD/P). Participants will use the BD for 5 days and will receive study drug for 7 days. Participants will be monitored for an additional 4 days after device removal to determine whether withdrawal resumes. Participants will undergo a second naloxone challenge after removal of the device/capsule completion to verify lack of opioid tolerance and will be encouraged to begin treatment with oral naltrexone followed by extended release naltrexone. Throughout the residential stay, all participants will be given referral to and assisted with engaging in outpatient treatment following study discharge.
Background: People with opioid-use disorder (OUD) might benefit from having more treatment drugs to choose from. A new drug, TRV734, could be used like methadone to treat OUD. It might not have as many side effects. Objective: To test if TRV734 relieves withdrawal symptoms and has fewer side effects than oxycodone in people with OUD. Eligibility: People ages 18-75 who have been receiving daily treatment with methadone for opioid use disorder for at least 3 months Design: Participants will be screened under Protocol 415. They will be screened with: Medical, social, and psychiatric history Physical exam Electrocardiogram (ECG). For this, sticky pads will be placed on the participant s chest to monitor their heartbeat. Blood and urine tests Participants will stay in a residential unit for 13-21 days. Most days, participants will receive their regular daily dose of methadone. On 4 or 5 occasions, 3-4 days apart, participants will skip two doses of methadone in a row. About 4 hours after they skip the second dose, they will have an IV catheter inserted with a needle so that blood samples can be taken. They will take capsules of either oxycodone, a placebo, or the study drug. They will have an ECG. They will complete questionnaires. Their blood pressure, pupil size, and alertness will be tested. They will then take their usual dose of methadone. Participants will give daily urine and breath samples.
TCN PATHS will recruit an anticipated 400 participants who are prescribed MOUD who are released from detention facilities. Each individual will be randomized to either 1) standard primary care (SPC) or 2) a Transitions Clinic Network (TCN) program primary care. Participants will be followed for a year and complete surveys at baseline and at month 1, 3, 6, 9, and 12. At each of these points research staff will confirm MOUD status. Urine drug screenings will be completed at baseline, month 1, 6, and 12 if the participant is not incarcerated. When possible, research staff will collect electronic health records.
This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.
There are two study periods for the TCU JCOIN project. The primary aims of Study 1 (approved by the TCU IRB) are (1) to gather information from staff on the current treatment referral process within participating communities and (2) to learn about the existing interrelationships between medical and community behavioral health (CBH) providers. TCU IRB granted approval for Phase 1 on 11/07/19, approval number: 1920-60-AM1. Study 2 (under current review by the TCU IRB) includes recruitment across 18 community collaboration sites across 3 states; these communities will participate in the TCU Opioid-Treatment Linkage Model (O-TLM) protocol. The O-TLM is focused on best practices for improving screening, identifying and linking to MOUD providers, reducing stigma, and addressing other important factors that impact justice-involved individuals returning to their communities. Along with their agency records, information collected from justice-involved individuals within the target communities will be examined to assess O-TLM impact on improving public health and public safety outcomes. Furthermore, stakeholder staff across community organizations, including criminal justice and treatment agencies, will be asked to complete surveys on the O-TLM regarding its acceptability and adoption, as well as on best training strategies.
Summary of Study Protocol. This project is designed to test neurobehavioral mechanisms underlying effects of the dual orexin-1/2 receptor antagonist suvorexant on sleep efficiency and opioid abstinence, and whether these outcomes are independent of one another. This will be the first study to investigate whether suvorexant improves outpatient opioid abstinence and sleep efficiency; and whether improving sleep mediates the improved opioid abstinence outcome. 120 participants with opioid use disorder (OUD) will complete this intent-to-treat study.
Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined.
Collaborative care for mental health is increasingly common, but most primary care practices have not embraced similar models for opioid use disorder (OUD). This study will refine and test a collaborative care model for patients with opioid use disorder (OUD) and depression, anxiety or post-traumatic stress disorder (PTSD) in primary care. We also will examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models.
INtegrated Support Persons Into Recovery (INSPIRE) is a 4-year research project that tests whether integrating a patient's support person into a patient's treatment with Buprenorphine/Naloxone can improve outcomes. The study will examine whether a counseling program called CRAFT for a support person, such as a family member, spouse or friend, can improve patient outcomes.
The current first-line treatment for opioid use disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal symptoms prior to induction, which can be a major barrier in starting treatment. Rapid micro-induction (also known as micro-dosing, low-dose induction) involves the administration of small, frequent does of bup/nx and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of bup/nx in patients with OUD.