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Opioid-Related Disorders clinical trials

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NCT ID: NCT03729388 Not yet recruiting - Opioid-use Disorder Clinical Trials

Treatment for Opiate Addiction: Prognostic fActors of Responsiveness to Maintenance Treatment

TOPAZE
Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

A global and integrative treatment of opioid-use disorders (OUD) with opiate maintenance therapy (OMT) and psychosocial interventions is recommended by all current guidelines. Treatment of OUD aim at prevents risks and consequences of opioid use (death by overdose, contamination with infectious diseases, mental and physical degradation, social exclusion and decrease of quality of life). OMT are approved since more than 20 years for OUD and a large number of patients have been treated. Nevertheless, identification of prognosis factors associated with good outcome is still limited. OMT duration, high dosages of OMT and patient good consistency have been identified as good prognosis factors but other individual factors could be involved and explain why OMT isn't as effective for all patients. The investigators assume that social environment, other addictive behaviors, psychiatric comorbidities, personality disorders and pharmacogenetics parameters might be of interest. Association between phenotype/ genotype, safety of OMT and therapeutic outcome will be especially assessed. For voluntary patients specific tools for risk reduction will be implemented (screening of infectious diseases with blood tests and fibrosis with fibroscan). Thus, the aim of TOPAZE study is to highlight prognosis factors for good outcome in the treatment of OUD moderate to severe at 12 months follow-up. Three main axes will be considered: clinical, pharmacological and pharmacogenetics.

NCT ID: NCT03718065 Not yet recruiting - Opiate Dependence Clinical Trials

Lofexidine's Impact on Stress and Opiate Use

Start date: January 2, 2019
Phase: Phase 2
Study type: Interventional

Individuals with opioid use disorder who are stabilized on buprenorphine will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task. Throughout the study a CREMA app (Cue Reactivity Ecological Momentary Assessment) will be used to monitor stress, craving and use in the natural environment.

NCT ID: NCT03698669 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

TOPPS
Start date: February 2019
Phase: N/A
Study type: Interventional

Treating Opioid Patients' Pain and Sadness (TOPPS) focuses on the relationship of pain, depression, opioid and other substance misuse, and functioning. It has a structured agenda, uses behavioral activation, involves explicit and ongoing psychoeducation, and includes a behavioral health specialist (BHS) trained extensively in the nature of pain and opioid misuse, including how to assess for red flags of opioid relapse. Devised specifically for primary care patients receiving buprenorphine, TOPPS is collaborative (PCP, BHS, and patient) and focuses on pain and physical symptoms in order to decrease the need to turn to substance misuse to avoid pain, and to foster patient's abilities to achieve their long-term life goals. In this study, TOPPS is compared to a health education contact-control condition among 250 persons with opioid use disorder recruited from two primary care based buprenorphine programs. The investigators will provide both interventions over 3 months, and follow the patients for a total of 12 months in order to observe both short-term and longer-term effects of TOPPS.

NCT ID: NCT03684681 Not yet recruiting - Clinical trials for Opioid-Related Disorders

The Navigator Trial

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

In this study, the investigators will investigate if there is a better intervention for patients who present to the emergency department with an overdose or with symptoms consistent with drug use. There are currently two interventions that are routinely used when a patient comes to the Emergency Department with these criteria, and the investigators will compare the two. The first is when hospital social workers uses their own previous training to help people meet their goals. The second is when a person called a peer navigator, who is someone that has been in long-term drug recovery for over two years and has completed a lot of training to work with current drug users, delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals. The investigators hope to determine if patients have better outcomes if they work with one of these two groups. If a patient agrees to be in the study, the research staff will randomize them (like flipping a coin) to see if they will work with a social worker or a peer navigator. The research staff will distribute a survey in RedCap and the following information will be collected: age, sex, race, type of opioid used, and history of chronic pain, depression or post-traumatic stress disorder. Once the patient is assigned to a group, they will work with their assigned interventionist for the duration of the study. After this, the research team will track the patient to see if they joined an addiction-treatment program within 30 days of when the joined the study. The study team will also track patients to see if they had additional emergency department visits, additional overdoses, and if they successfully completed a treatment program over an 18-month period. 650 patients will be enrolled into the study.

NCT ID: NCT03681769 Recruiting - Chronic Pain Clinical Trials

Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent

Start date: October 2018
Phase: Early Phase 1
Study type: Interventional

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 still largely treated with opiate narcotics, much as was done in the Civil War. In addition to the 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. Aim 1. Evaluate repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: DLPFC TMS will attenuate the baseline brain response to pain (Pain Network activity) and increase activity in the Executive Control Network (ECN) when the patient is given instructions to 'control' the pain. Aim 2. Evaluate Medial Prefrontal Cortex (MPFC) rTMS as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: MPFC TMS will also attenuate the baseline brain response to pain (Pain Network activity) but will not effect the ECN or the Salience Network (SN) when the patient is given instructions to 'control' the pain.

NCT ID: NCT03678792 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Comparison of Three Opioid Detoxification Treatment Regimens

Start date: November 2018
Phase: Phase 3
Study type: Interventional

Despite an increased focus on treating opioid use disorder there are relatively few studies that compare the length of time required for detoxification with medications other than buprenorphine. Morphine and tramadol have shorter half-lives than buprenorphine and can be used for opioid detoxification. The proposed protocol aims to address this gap by directly comparing the length of treatment required for detoxification from opioids in a patient-centered manner with oral morphine, tramadol, or buprenorphine-naloxone as well as comparing the severity of withdrawal experienced by patients in each group. The investigators predict that treatment with oral morphine or tramadol will result in a faster completion of detoxification and initiation of naltrexone maintenance.

NCT ID: NCT03662529 Completed - Cocaine Dependence Clinical Trials

Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting

Start date: June 5, 2017
Phase: N/A
Study type: Interventional

This study was an internal program effectiveness evaluation of the effects of a four-session weekly individualized cognitive therapy program (called the "Mind Freedom Plan" (MFP)) on substance use outcomes and substance abuse treatment retention in Veterans admitted to an intensive outpatient treatment program for substance abuse at the Richmond Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention metrics of MFP-assigned Veterans were compared with those of Veterans assigned to typical case-management-oriented weekly individual sessions.

NCT ID: NCT03656120 Not yet recruiting - Opioid Dependence Clinical Trials

A Study of Thienorphine Hydrochloride Tablets in Relapse Prevention Treatment of Opioid Dependence

Start date: August 31, 2018
Phase: Phase 2
Study type: Interventional

Opioid addiction is common worldwide. Thienorphine hydrochloride is a newly partial opioid receptor agonist drugs. It`s affinity with opioid receptors was much higher than opioids, which could effectively prevents opioid dependence by stop opioids competition for opioid receptors and causing opioid dependence. The aim of this research was to determine whether thienorphine hydrochloride would reduce opioid use and better preventing relapse among opioid addicts.

NCT ID: NCT03635346 Completed - Chronic Pain Clinical Trials

Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD

DEMDOU
Start date: June 3, 2016
Phase:
Study type: Observational

prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain. the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.

NCT ID: NCT03610672 Recruiting - Clinical trials for Opioid-Related Disorders

Mobile Intervention for Young Opioid Users

Start date: September 15, 2017
Phase: N/A
Study type: Interventional

Opioid use disorders (OUD) are the second most common type of drug use disorder in the US, with nearly 2 million Americans with prescription opioid- (PO) and ~570,000 with heroin-related OUD. The escalation in OUD during the past two decades has been most pronounced among youth, many of whom demonstrate a rapid transition from nonmedical PO use (16-17 y/o), to heroin (19-20 y/o), with most progressing to injection drug use (IDU), within a year of starting heroin use (20-21 y/o). Progression to IDU is characterized by uniquely high levels of risk for youth, including higher rates of overdose (OD) and HIV and HCV incidence, compared to older peers. Addiction severity, psychosocial functioning, and social networks are robust predictors of transitioning to IDU; however there is virtually no research on how to prevent or halt this transition to IDU. Given the paucity of interventions targeting this large and vulnerable group of youth, we propose to adapt and evaluate an innovative, engaging mHealth intervention to prevent young opioid users (18-29) from transitioning to IDU. Aim 1: During months 1-12, we will adapt our existing mobile intervention for OUD that includes daily text messages plus key components of evidence-based CBT interventions, including Functional Analysis of Drug Use, Self-Management, and Social / Recreational Counseling. New components specific to youth will focus on the role of peers on opioid use and IDU, and OD prevention / response training. Our iterative development process will include focus groups with opioid-using youth (n=24), interviews with important stakeholders (e.g., youth treatment providers; n=6), and feedback and usability data from opioid-using youth (n=30). Aim 2: During months 13-31, we will conduct a small randomized, controlled trial of the tailored mHealth intervention with young opioid users who have not transitioned to regular injection (n=64) and compare (1) assessment plus in-person OD prevention / response training (including naloxone) versus (2) assessment plus in-person OD prevention / response training (including naloxone) plus our mHealth intervention. Feasibility and acceptability will be assessed via participant feedback, retention, and usage data. Diffusion will be defined as the number of participants' peers who download the intervention app for their own use. Preliminary effectiveness will be measured via reductions in opioid use (TLFB, urine / hair toxicology) and self-reported injection status at 4, 8, and 12 weeks, and 3 and 6 month follow-up. Secondary outcomes include HIV/HCV risk behavior, OD, opioid-related problems (e.g., withdrawal episodes), and social network IDU-related norms and behaviors. If results are promising, this novel intervention will be expanded for examination in a large-scale efficacy / effectiveness trial.