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Showing 1-20 of 81 trials
NCT03787628
This research aims to determine the effects and safety of cannabidiol (CBD) (ATL5 softgel capsules) as an adjunctive therapy for patients who have Opioid Use Disorder and are taking buprenorphine + naloxone or methadone. Buprenorphine + naloxone and methadone is an approved treatment for Opioid Use Disorder, but relapse to opioid misuse is common among patients who receive this treatment. Finding an adjunctive treatment for these patients would be helpful. We will recruit participants from the Tarzana Treatment Center (TTC) in the San Fernando Valley. They will be receiving buprenorphine + naloxone or methadone as part of residential therapy. Potential participants who pass initial screening and wish to continue in the study will provide written, informed consent and will complete a 2-day evaluation, including blood and urine tests, questionnaires about their mood, medical, psychiatric and drug use history and physical exam. Up to 60 participants who meet all eligibility criteria will be invited to complete baseline assessments (blood and urine tests, questionnaires), and will be assigned randomly to receive CBD (600 mg/day) or placebo, corresponding to two groups of up to 30 participants each. After the baseline measurements, participants will take part in a 28-day treatment phase for 4 weeks. They will take the study medication under supervision (CBD 300 mg twice daily or placebo). Questionnaires on opioid craving, withdrawal, and mood symptoms will be administered daily during the treatment period, excluding weekends. After the 28-day intervention, participants will complete the questionnaires and undergo urine drug tests in 4 weekly follow-up visits. The study will last \~10 weeks, comprising three periods: a screening period (2-weeks when participants are stabilized on buprenorphine + naloxone or methadone in residential treatment at the Tarzana Treatment Center), a treatment period (4 weeks when study CBD or placebo is administered at Tarzana Treatment Center), and a follow-up period (4 weeks after termination of the test intervention).
NCT04736550
The purpose of this pilot trial is to determine the feasibility of integrating exercise and psychotherapy that is specifically targeted to reducing and managing pain into residential drug treatment programs. The investigators will evaluate the feasibility (adherence) of integrating 'assisted' rate cycling, voluntary rate cycling and psychotherapy for pain (I-STOP) in participants with an opioid use disorder (OUD) and pain enrolled in residential drug treatment programs. The investigators will also explore the potential effects of 'assisted' rate cycling, voluntary rate cycling and I-STOP on pain, cravings, depression, anxiety, weight and sleep.
NCT04197921
The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.
NCT03895827
This study targets individuals in Chicago who have received naloxone administered by first responders within the past week to reverse an overdose, but who have not entered into MAT. Study participants will be recruited through partnerships with the Chicago Fire Department (CFD) and/or Police Department (CPD); first responders will be trained to seek consent from individuals who are alert and oriented after receiving naloxone for future contacts by research staff as part of the naloxone standard protocol. Those who consent will be contacted and screened for study eligibility ideally within one week of naloxone administration; eligible participants will be randomly assigned either to the control group, i.e., referral to MAT as usual, or to Recovery Initiation and Management after Overdose (RIMO), an assertive linkage and recovery support intervention. This intervention builds on an evidence-based intervention for treatment linkage, monitoring, and recovery support evaluated in 3 prior clinical trials by the study team.
NCT04379115
The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.
NCT05033028
Treatments for opioid addiction exist, but effectiveness is compromised when subjects use illicit opiates during treatment. Reuse rates during treatment can be high, and reducing illicit opiate use during treatment has thus recently become a major NIDA policy goal. The 5-minute battery indicates the numerical probability that a patient will reuse illicit opiates within the next 7-10 days.
NCT04927143
Combatting the rise of the opioid epidemic is a central challenge of U.S. health care policy. A promising approach for improving welfare and decreasing medical costs of people with substance abuse disorders is offering incentive payments for healthy behaviors. This approach, broadly known as "contingency management" in the medical literature, has repeatedly shown to be effective in treating substance abuse. However, the use of incentives by treatment facilities remains extremely low. Furthermore, it is not well understood how to design optimal incentives to treat opioid abuse. This project will conduct a randomized evaluation of two types of dynamically adjusting incentive schedules for people with opioid use disorders or cocaine use disorders: "escalating" schedules where incentive amounts increase with success to increase incentive power, and "de-escalating" schedules where incentive amounts decrease with success to improve incentive targeting. Both schemes are implemented with a novel "turnkey" mobile application, making them uniquely low-cost, low-hassle, and scalable. Effects will be measured on abstinence outcomes, including longest duration of abstinence and the percentage of negative drug tests. In combination with survey data, variation from the experiment will shed light on the barriers to abstinence more broadly and inform the understanding of optimal incentive design.
NCT04995029
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine. The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 mg maintenance doses of extended-release buprenorphine administered every 4 weeks.
NCT04783558
Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies while they are pregnant, yet, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial.
NCT04706624
The investigators propose to develop and evaluate optimal combinations of evidence-based interventions to improve HIV outcomes and reduce methamphetamine use (hereafter: meth use) among people with opioid use disorder who are in methadone maintenance therapy (MMT) in Vietnam. Over the past decade, the expansion of MMT has contributed to stemming both HIV and opioid epidemics. However, rising meth use threatens these achievements. Evidence-based interventions such as Motivational Enhancement Therapy, Contingency Management, Matrix Model, and SMS reminders are effective in reducing meth use. The study will be conducted in the two largest cities in Vietnam, Hanoi and Ho Chi Minh City (HCMC), where there are the highest number of MMT patients and the highest burden of HIV cases. Building on the pilot work of the research team in Hanoi, through collaborative work with local MMT providers and patients, the investigators will first further refine adapted EBIs to develop adaptive strategies. The adaptive design includes: (1) Two frontline interventions: 6 weeks of contingency management then 6 weeks of weekly group educational sessions and 12 weeks of contingency management; (2) One (short-term) tailoring outcome: urine tests negative with meth metabolites in both week 11 and 12 are considered responsive to frontline interventions; (3) Three alternative interventions: those with positive outcomes will move to 12-week maintenance stage and receive two daily SMS reminders plus one weekly self-monitoring assessment messages. Non-responders will move to 12-week enhanced treatment stage and are randomly assigned to either Matrix group counseling only or Matrix group counseling plus contingency management. The full randomization trial will be conducted with 200 HIV-positive and 400 HIV-negative MMT patients who report moderate- and high-risk meth use on self-screening with ASSIST or have urine positive with meth metabolites. In each location, the study will stratify participants by HIV status before randomizing them to one of two frontline interventions. Primary outcomes - including HIV viral suppression, HIV risk behaviors, and meth use (reported and urine tests) - will be assessed at 12, 24 and 48 weeks. The study team also conducts ethnographic observations and in-depth interviews with MMT clinic managers, clinical staff and MMT patients to explore implementation barriers and facilitators.
NCT04354077
This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.
NCT04091009
The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. The management of pain after surgery in adults taking buprenorphine can be challenging, as buprenorphine may interfere with the effectiveness of other medications used to treat pain. The investigators want to compare how well pain is managed after surgery ("post-op") in two groups: The "Continue Group": those who continue taking their standard dose of buprenorphine before, during and after surgery. The "Reduce Group": those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, participants will be put back on their full dose of buprenorphine. The investigators also want to find out if there is a difference in pain, opioid cravings, and relapse rates in the month following surgery.
NCT05047627
The majority of opioid users meet criteria for anxiety and depressive disorders, but most substance use disorder treatment programs do not offer treatment for co-occurring mental health problems. Anxiety and depression may also be directly linked to opioid use itself. Although treatments have been developed for anxiety and depressive symptoms for opioid users within face-to-face settings, few treatment facilities offer these in-person interventions due to their high cost and time burden. Given the deficits in research on treatments for anxiety and depression among those with opioid use disorder, the current research will examine the efficacy of a digital intervention designed to treat anxiety and depressive symptoms by augmenting the state of the science medication-based opioid use disorder treatment. Over the course of the proposed study, the research team will design and test the feasibility and acceptability of a standalone mobile intervention designed to treat persons receiving medication treatment for opioid use disorder. Participants receiving medication treatment for opioid use disorder will be randomized to receive a digital intervention to treat anxiety and depression or care as usual for a total of four weeks. The overarching goal of the proposed work is to test the feasibility and acceptability of the proposed mobile intervention. The Investigators will also explore the preliminary efficacy by examining reductions in anxiety and depressive symptoms and opioid cravings and use. This work could lead to a low-cost scalable solution to augment gold-standard treatment as usual in opioid use disorder by decreasing levels of comorbidity of anxiety and depressive disorders, thereby ultimately improving the outcomes of opioid use disorder itself.
NCT04198428
Through CTN-0076-Ot (Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR (COMPUTE)), our team has iteratively developed and piloted a web-based and electronic health record (EHR)-integrated Opioid Use Disorder (OUD) Clinical Decision Support (CDS) system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD. The OUD-CDS has been implemented within the EPIC EHR of one large care system and was piloted with 55 providers to ensure content validity and provider satisfaction. The team will now implement this OUD-CDS in a large multi-site clinic-randomized controlled trial to evaluate its impact on practice process measures and patient outcomes. The investigators also aim to prepare for scalability (i.e., integration into usual primary care practice after the study is complete) and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance, and assessing the short-term cost impacts of the OUD-CDS. The study will include three large diverse care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). In intervention clinics, the OUD-CDS will identify patients who are at high risk for OUD or diagnosed with OUD; use data stored in the EHR for each eligible patient to assemble treatment recommendations tailored to each patient's current needs; display these recommendations to PCPs via the OUD-CDS user interface; and store analytic data from all targeted visits. In UC clinics, the OUD-CDS will run invisibly in the background to identify high-risk or OUD patients, assemble treatment recommendations tailored to each eligible patient's needs, and store analytic data from all targeted visits.
NCT04173416
Youth are disproportionately affected by the current opioid crisis with catastrophic consequences, and young adults with opioid use disorder (OUD) often struggle with adherence to relapse prevention medications. The Youth Opioid Recovery Support (YORS) model is a promising, innovative, wrap-around approach that addresses barriers to medication adherence and treatment engagement in an effort to improve public health outcomes in this vulnerable young adult population. This study seeks to refine the YORS intervention through stakeholder input and pilot iterative testing followed by an efficacy randomized controlled trial. This project will significantly contribute to our knowledge base of practical strategies to address the opioid crisis.
NCT04759703
The investigators propose to test the use of pramipexole in patients being treated for Opioid Use Disorder to test its ability to reduce symptoms of both Restless Legs Syndrome and protracted opioid withdrawal and thereby promote initiation, engagement, and retention in treatment.
NCT03135886
This study will test two active evidence-based "practice coaching" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site 1) HIV testing and linkage to care and 2) HIV/Hepatitis C virus (HCV) testing and linkage to care among patients seeking/receiving substance use disorder treatment. Aims are: Aim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIV/HCV intervention on HIV testing. Aim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care. Aim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition. Primary Hypothesis: 1. The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the "initial impact" period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Primary) and during the "sustained impact" period, 13-18 months post-randomization or T4 (Secondary). 2. The HIV/HCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Secondary) and during the "sustained impact" period, 13-18 months post-randomization or T4 (Secondary).
NCT04433975
The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.
NCT05053503
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
NCT04958798
This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.