Active clinical trials for "Opioid-Related Disorders"

The purpose of this clinical trial is to examine the efficacy and cost-effectiveness of an interactive, computer-based psychoeducational system when used by opioid-dependent patients in office-based buprenorphine treatment.

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.

This is an observational study of morbidly obese patients recovering from general anesthesia after weight-loss surgery. The investigators aim to assess ventilatory function and how this is influenced by the diagnosis of obstructive sleep apnea (OSA), baseline ventilatory status, as well as pharyngeal collapsibility of patients who are recovering from anesthesia and treated for pain with opioids. The investigators hypothesize that patients with OSA, chronic (baseline) hypoventilation and increased pharyngeal collapsibility, will be more vulnerable to opioid-induced ventilatory depression.

The purpose of this study is to determine whether combined hemoperfusion-hemodialysis treatment is an alternative drug-free, effective, and safe treatment for opiate detoxification.

The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.

The planned research will adapt an intervention of known efficacy to target a new outcome of significant importance to public health. Specifically the Community Reinforcement and Family Training (CRAFT) procedures will be adapted, from reinforcing treatment entry, to reinforcing treatment retention and HIV risk behavior reduction in persons with opioid dependence who receive a Buprenorphine taper detoxification. The research plan includes three phases: 1) development of a manual guided therapy, 2) development of therapist training and fidelity measures and 3) a randomized pilot evaluation with 52 patients receiving either the new CRAFT treatment or treatment as usual.

The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.

The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. The system introduces psychological and behavioral supports in addition to securing the medication between doses.

This is a clinical trial evaluating anxiety reduction for women with opioid use disorder affecting pregnancy. It is well documented that anxiety increases as pregnancy progresses. We hypothesize that women who undergo green light therapy (experimental arm) will have a smaller increase in anxiety scores compared to the women who undergo white light therapy (control arm). We will also look at how much opiate replacement therapy increases women require during the study period, and how much opiate they require during admission for delivery. We think this a is a low risk intervention in a pregnant population that has higher levels of anxiety when compared to the general population. We believe based on animal studies that this could be effective, and change the way we treat and support individuals with substance use disorder. The opioid epidemic has negatively impacted our society at many levels. Finding non-pharmacologic ways to support patients while in recovery/sustained sobriety that are simple and low cost would be a step forward in providing compassionate and comprehensive treatment to individuals affected by Opioid Use Disorder.

Opioid use disorder (OUD) is prevalent and causes substantial health and social burdens. Although evidence have showed the effectiveness of opioid agonist maintenance therapy in OUD, high drop-out rate and the requirement of continuing use of opioid agonists are the major problems. Therefore, to develop novel treatment for OUD is important. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method of brain stimulation used to treat a variety of neuropsychiatric disorders. Recent studies showed that there may be potential therapeutic effects in rTMS for addictive disorder, including reducing craving and substance use severity. The underlying mechanisms of rTMS in treating addictions may involve increased dopamine function in corticomesolimbic brain circuits and modulation of neural activity in brain circuits that relevant to addiction. However, the treatment results of rTMS in OUD were lacked, and the analysis in functional brain imaging study, neuropsychological tests and other potential biomarkers under rTMS treatment were limited, too. Thus, the investigators will conduct the add-on double-blinded, sham-controlled study rTMS treatment in 40-60 patients with OUD under methadone maintenance therapy. Patients will be allocated to active and sham rTMS in a 1 : 1 ratio, and participants will receive rTMS on the left dorsolateral prefrontal cortex (DLPFC) (15 Hz frequency, 4 seconds per train, inter-train interval of 26 seconds, 40 trains per session, total 11 sessions in 4 weeks). The treatment response, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of rTMS will be examined. Neuropsychological assessments, functional magnetic resonance imaging (fMRI) and tests for potential biomarkers of immune parameters will also be measured during 12-weeks follow up. The study results will provide the important data in whether rTMS add-on methadone maintenance therapy is able to 1) reduce heroin use; 2) reduce craving for heroin; 3) be an effective treatment for OUD, and 4) be associated with improvement in fMRI, biological markers and psychological tests.