View clinical trials related to Opioid-Related Disorders.
Filter by:The objective of this observational, prospective study is to evaluate the incidence of chronic pain at 3 months after ICU discharge in patients with a prolonged ICU stay (i.e. ≥3 days). Investigators will assess the proportion of patients with chronic pain (defined according to the Brief Pain Inventory questionnaire), by interview at 3 months after ICU discharge. All data potentially associated with chronic pain will be collected, including the type of surgery, the acute pain (intensity and duration) during the ICU stay, the type and dose of opioids received, patients comorbidity... Patients will be follow-up at 6 and 12 months to identify impact on quality of life.
Effective control of chronic pain is a top priority in the United States, as approximately 10% of adults have severe chronic pain most of which is chronic lower back pain (CLBP). However, despite the advances in neuroscience over the past 20 years, chronic pain is largely treated with opiate narcotics, much as was done in the Civil War. In addition to their high abuse liability and dependence potential, only 30 40% of chronic pain patients declare they receive satisfactory (>50%) relief from their pain through pharmacological treatment. In these patients a common clinical practice is to escalate the dose of opiates as tolerance develops which unfortunately has contributed to escalation in opiate overdose deaths, a resurgence of intravenous heroin use, and $55 billion in societal costs. Consequently, there is a critical need for new treatments that can treat pain and reduce reliance on opiates in individuals with chronic pain. The proposed study will be the first to employ a randomized, double-blind, sham-controlled design to parametrically evaluate the longitudinal effects of 16 days of Repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex (MC) or the medial prefrontal cortex (MPFC) on self-reported pain and the brain s response to pain. This will be done in a cohort of patients recruited from the community as well as Wake Forest Baptist Health (WFBH) clinics with chronic lower back pain that have not been able to find adequate pain relief, whether or not they are using prescription opiates for 3 or more months. Participants will be randomized to receive rTMS to the MC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected 3 times: before the 1st day of TMS, after the 12th day of TMS, and before the 16th day of TMS (the last day administered).
An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 days.
This study's specific aims were to: develop a digital intervention as a prevention intervention through focus groups with 40 youth; pilot-test the developed digital intervention with 30 adolescents, using methods from the investigator's prior research; develop implementation strategies and partners through focus groups with 50 School Based Health Alliance affiliates and 30 adolescents from an Advisory Council.
Among patients with opioid use disorder (OUD), 90% report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of OUD and PTSD is associated with worse mental health and opioid agonist treatment (OAT) outcomes relative to either diagnosis alone. Prolonged exposure therapy (PET) is an efficacious cognitive-behavioral treatment for reducing PTSD severity. Although preliminary findings indicate that PET may reduce PTSD symptom severity among patients receiving treatment for concomitant OUD, it is unclear to what extent improvements were a function of PET versus the effects of OAT itself. Therefore, the question of whether OAT alone may attenuate PTSD symptoms in the absence of intensive cognitive-behavioral therapy remains unanswered. In this 12-week trial, we aim to investigate the contribution of PET above and beyond OAT alone for reducing PTSD symptoms among adults with concurrent PTSD and OUD. Participants will be randomized to one of three conditions: (a) OAT as usual, (b) OAT + PET, or (c) OAT + Enhanced PET (OAT+PET+). Those randomized to OAT as usual will continue to receive standard buprenorphine or methadone treatment from their current treatment provider and complete assessments of PTSD symptom severity, psychosocial functioning and drug use at intake and Study Weeks 4, 8, and 12. In addition to receiving OAT and completing monthly assessments, OAT+PET participants will receive PET consisting of 12 weekly, individual sessions with a trained therapist. Finally, OAT+PET+ participants will receive the procedures noted above for the OAT+PET group plus monetary incentives delivered contingent upon completion of PET sessions. Given the poor PET adherence rates reported among patients with substance use disorders, the use of incentives will ensure that we evaluate PET effects among patients who receive a sufficient dose of therapy. The proposed study design will permit us to disentangle the effects of PET from the effects of OAT alone while also including experimental conditions that reflect real-world practice. Taken together, this project will produce important new scientific and clinically-relevant information related to the mechanisms through which OAT and PET promote reductions in PTSD symptomatology in a highly vulnerable clinical population.
This study aims to determine whether referral to the Bridge Clinic reduces overall index hospital length of stay when compared to direct referral to a long-term outpatient addiction provider for patients with active opioid use disorder (OUD) being considered for medications-for-addiction treatment (MAT).
The national opioid epidemic requires development of real-world evidence-based treatments for opioid use disorder, including adjuncts to Medication for Opioid Use Disorder (MOUD). Interventions are needed that address the complex needs of patients with opioid use disorder, which include substantial mental health co-morbidity and high rates of chronic pain related to the complex interaction of opioid prescribing for pain and opioid use disorder. This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MOUD in multiple clinical settings funded primarily through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+ MOUD vs. MOUD only. The overarching goal of this application is to test MABT to improve MOUD health outcomes. The specific aims for the combined R33/R01 clinical protocol are to: 1) evaluate the effectiveness of MABT + TAU (MOUD) compared to TAU only in reducing opioid use and other substances; 2) examine the effectiveness of MABT + TAU to improve mental and physical health vs. TAU only; 3) examine the effectiveness of MABT + TAU to positively affect substance use related outcomes of craving and treatment retention vs. TAU only. For the R01, there is an additional aim to explore the effectiveness of additional MABT dose offered at 6 months to those with continued substance use (non-responders) compared to those with continued substance use at 6 months in TAU. A two-group (n = 165/165), randomized controlled repeated measures design will be employed. Three hundred thirty individuals engaged in MOUD will be recruited for participation at outpatient treatment sites. Assessments will be administered at baseline, post-intervention (3 months from baseline), and at 6, 9, and 12 months. Results of this study will inform the evidence base for behavioral treatment adjuncts to MOUD and directly impact the future direction of the Washington Opioid STR program.
This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and feedback. The cases and feedback have been designed to align with the latest CDC opioid guidelines. The study will also measure the impact of gaming-inspired competition and motivation, including a weekly leaderboard, to improve evidence-based care decisions. The quality of care decisions will be measured in the simulations and in a multiple-choice assessment administered before and after the patient simulations.
The objective of this observational feasibility project is to assess the feasibility and acceptability of universal screening and measurement based care for opioid use disorder (OUD) utilizing a computer software program in a network of primary care clinics currently utilizing this software for screening and measurement based care (MBC) for the treatment of depression. The primary objective of this project is to evaluate the feasibility of screening and MBC for OUD in our partner primary care clinics. The secondary objective of this project is to evaluate the acceptability of universal screening and measurement based care of OUD, including the barriers and facilitators of screening for OUD and providing buprenorphine treatment in primary care, changes in provider knowledge and beliefs regarding diagnosis and treatment of OUD, and treatment program outcomes.
This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids.