View clinical trials related to Opioid-Related Disorders.
Filter by:This study proposes to examine the safety, tolerability, and pharmacokinetics (PK) of NYX-783 50 mg and 150 mg versus Placebo (PBO) in combination with acute Oxycodone 15 mg and 30 mg in an inpatient randomized, cross-over study in non-treatment seeking non-dependent, opioid experienced individuals with current recreational use.
Background Back pain is among the most common cause for sick leave in the working population and is the main cause of years lived with disability globally. In Norway, about 30% report to live with chronic pain and women are affected more than men. Pharmacological strategies for pain management e.g., opioid medications, is a common treatment method. This is despite clinical guidelines suggesting limiting pharmacological treatment in management of chronic back pain. Long-term use of opioids is linked to opioid-induced hyperalgesia, paradoxically. However, it is suggested that RNA sequencing (seq.) profiling may identify individuals that are at risk of opioid-induced hyperalgesia. To help reduce medication intake brief intervention (BI), a method for discontinuing long-term medication use, has shown to be successful. In this pilot RCT the investigators aim to investigate the feasibility of a full scale RCT and observational study using BI on opioid-using patients with back pain and concurrently study if the response can be predicted by RNA seq. Method Ten outpatients aged 18-67 years with back pain will be recruited from the orthopaedic department at Akershus University Hospital. Inclusion criteria includes daily use of opioids for more than two weeks consecutively, and sufficient language (Norwegian) skills. Exclusion criteria includes severe medical or surgical condition such as cauda equina syndrome, rheumatic disease, psychiatric disease, or recent surgery. The patients will be randomised into two groups (5+5) where one group receives the BI and the other gets treatment as usual. Data collection will be conducted at three-time points; baseline, four weeks follow-up and three months follow-up (end of trial). The primary outcome for this pilot RCT is to test feasibility and estimate effect size for a later full-scale study. Secondary outcomes include subjective and objective findings from the data collection. Results Primary results concerning feasibility are mainly qualitative and will be presented as such. Secondary results including demographic information as well as tentative effect size, patient reported outcomes such as pain intensity, anxiety, depression, quality of life, psychosocial stressors in the workplace and the RNA seq will be presented descriptively. Conclusion The results from this pilot study will assist in constructing the optimal design for a full-scale RCT.
Study rationale Opioid use disorder (OUD) is a chronic and severe condition, defined by problematic opioid use, which results from interactions among sociological factors, psychiatric symptoms and life experiences, altogether determining OUD severity. Recently, behavioral epigenetics has emerged as a possible strategy to help identify molecular mechanisms that may explain how these various interactions result in dysregulations affecting gene expression, brain function, and, ultimately, emotional regulation. Here the investigators propose a pilot study as a first step towards a larger multidisciplinary project whose goal will be to characterize simultaneously major psychiatric and social factors in individuals with OUD, across a wide range of disease severity. In the present pilot study, the investigators propose to first characterize technical feasibility of the molecular investigations proposed in these 2 projects. OUD severity The severity of OUD is well defined in the DSM-5 (2013), with 3 categories, from mild to severe, on the basis of the number of dimensional criteria met by patients (among 11 criteria). These criteria relate to the following main aspects: tolerance, the need to increase the amount of drugs to avoid withdrawal; psychic and physic withdrawal in case of substance discontinuation; social and interpersonal consequences of drug use; biological and psychic consequences of use; and craving, the irrepressible need to consume1. Here, the investigators postulate that molecular adaptations detected in the blood of OUD patients may represent biomarkers of this severity. Epigenetic blood biomarkers A main limitation for conducting peripheral blood biomarker investigations in active opioid abusers comes from the fact that phlebotomies are reputedly difficult & potentially iatrogenic in these subjects, as they associate with external cues and trigger internal states that are closely related to drug consumption. To overcome this difficulty, we propose to test the hypothesis that sufficient DNA amounts can be recovered from fingerstick blood drops (corresponding to capillary blood, similar to sugar testing) to generate robust and reliable DNA methylation measures in the full human epigenome. In other words, the investigators assume that DNA methylation can be measured using capillary blood. Objectives The investigators will first investigate in healthy volunteers whether the method consisting in collecting and analyzing small DNA amounts from capillary blood (fingerstick blood drops) retrieves DNA methylation measures for a number of CG dinucleotide sites (where DNA methylation occurs in the mammalian genome) that is comparable to that classically observed using veinous blood (phlebotomy). Second, the investigators will test the feasibility of measuring DNA methylation using capillary blood samples collected from patients with OUD. To this purpose, the investigators propose to collect veinous and capillary blood samples from healthy volunteers, and capillary blood from opioid users.
The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.
The COVID-19 pandemic puts individuals recovering from opioid use disorders (OUDs), an already vulnerable population, at increased risk of overdose due to decreased access to treatment, decreased social support, and increased psychosocial stress. This proposal will test the efficacy of a promising mobile app-based peer support program, compared to usual care, in increasing recovery capital, improving retention in treatment, and reducing psychosocial adverse effects, among a national sample of people in recovery from OUD. If effective, it would provide an accessible, personalized, and scalable approach to OUD recovery increasingly needed during the COVID-19 pandemic.
The purpose of this study is to help Veterans who have opioid use problems with gaining and maintaining meaningful employment. The investigators also want to know employment helps with other aspects of the Veteran's life including starting and staying on necessary medications, mental health needs, and feeling a part of society.
Performance measure can improve quality of care at the patient, provider, and systems level of care, and patient-reported outcome measures bring a needed patient-centered focus. Recovery has been difficult to measure for people with substance use disorders, and is more challenging in the context of opioid use disorders (OUD) and treatment medications. This study will examine a recovery patient-reported outcome measure to determine if patients and clinicians find it useful and acceptable in the clinical context, and if it leads to improved outcomes.
Evaluate the feasibility of implementing workplace opioid guidelines in the construction trades; define and collect measures of implementation and efficacy. The investigators will implement the intervention in three local union health funds, evaluate the implementation using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, and collect the data needed to measure the efficacy of health changes due to implementation of the intervention (workplace opioid guidelines). This is only a feasibility trial in preparation for conducting an randomized control trial. For the efficacy trial, the investigators will measure pre-post health change using two data sources: 1) administrative health claims and electronic member work hours, and 2) worker/member surveys. To monitor implementation of the intervention, the investigators will measure changes made to the health funds opioid prevention program through qualitative interviews with the health fund manager and through worker surveys for worker awareness and use of the health fund program changes pre-post implementation. The efficacy outcomes for the administrative health (and pharmacy) claims and work hours record will measure opioid prescriptions, chronic opioid use, and OUD in health claims and pharmacy data (details below). The efficacy outcomes for the worker surveys will record changes in misuse of opioids, change in missed days/work productivity, change in attitudes toward seeking help if worker was struggling with opioid misuse, and awareness and use of health fund programs (i.e. employee assistance programs, healthcare recovery services). the investigators will collect data at baseline and and after 6 months for the study of implementation and efficacy (a pre/post design, one-arm trial).
This Phase II STTR program consists of two major goals within the overarching goal of developing and validating a proprietary device (BID2) for marijuana and opioid detection in breath samples.
This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment. All participants will be treated in an open label manner. No randomization will occur. The OLANI is a long-acting biodegradable form of naltrexone which is implanted in the abdominal region. It is hypothesized that the OLANI will produce blood levels sufficient to block the effects of opioids for an extended period allowing patients to engage in psychosocial treatment and recovery over the long term. After the initial set of implants, participants will be offered a second set of implants after 13-24 weeks.