Contemporary clinical trials最新文献

{"title":"Preventing \"tipping points\" in high comorbidity patients: A lifeline from health coaches - rationale, design and methods.","authors":"Mary E Charlson, Ilana Mittleman, Rosio Ramos, Andrea Cassells, T J Lin, Alice Eggleston, Martin T Wells, James Hollenberg, Paul Pirraglia, Ginger Winston, Jonathan N Tobin","doi":"10.1016/j.cct.2025.107865","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107865","url":null,"abstract":"<p><strong>Background: </strong>This paper describes an innovative cluster randomized controlled trial design to evaluate the comparative effectiveness of two approaches to preventing significant destabilization, leading to unplanned hospitalization and increased disability for patients with high comorbidity, that is, multiple chronic diseases defined by an enhanced Charlson Comorbidity Index ≥4.</p><p><strong>Methods: </strong>A total of 1974 patients were randomized in four waves at each of the sixteen Federally Qualified Health Centers (FQHCs) in four health systems -two in New York and two in Chicago. The two interventions compared 1) Patient-Centered Medical Home (PCMH) as implemented by the FQHCs (usual care control); or 2) PCMH plus a coaching intervention delivered by Health Coaches (experimental) helping patients identify life goals to encourage self-management enhanced by a positive affect/self-affirmation strategy. The two primary patient-centered clinical outcomes are 1) Unplanned hospitalizations; and 2) Within-patient changes in quality of life and disability, as measured by the World Health Organization Disability Assessment Scale 2 (WHODAS 2.0). The hypotheses are: 1) intervention patients will have a 5 % relative reduction in unplanned hospitalizations as compared to control patients; and 2) reduced disability measured by WHODAS2.0; 3) destabilization or 'tipping points' leading to hospitalization will be more often triggered by psychosocial issues than by medical Issues.</p><p><strong>Conclusion: </strong>This cluster RCT has the potential to transform the care for patients with high comorbidity by helping motivate patients to engage in self-management and to successfully navigate the barriers, challenges, and stresses leading to destabilization, hospitalization, and increased disability.</p><p><strong>Clinicaltrials: </strong>gov registration number: NCT04176510.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107865"},"PeriodicalIF":2.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a hybrid type 1 randomized clinical trial of a parenting intervention to enhance family well-being in underserved populations.","authors":"Casey Buck, Jon Phillips, Natalie Noble, Cristina Wilson, Amy Bielawski-Branch, Sydney M Hardy, Jessica Strolin-Goltzman, Matthew Price","doi":"10.1016/j.cct.2025.107863","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107863","url":null,"abstract":"<p><p>The child welfare system (CWS) in the United States faces persistent challenges in serving families from underserved communities, particularly those from Latine and African American/Black backgrounds and rural areas. These families encounter multiple barriers, including language and cultural differences and a lack of local services and access to transportation, which impede access to essential parenting programs. In response to the 2018 Family First Prevention Services Act (FFPSA) and other policy initiatives, the PRESERVE & CONNECT project aims to evaluate the efficacy of the Breakthrough Parenting Curriculum: Navigating Trauma Across Generations (BPC)-a trauma-informed and culturally-responsive parenting intervention-in preventing child maltreatment and promoting child and family well-being. A key aspect of the intervention is the inclusion of parents with lived experience in the CWS as co-facilitators, which enhances program credibility, trust, and engagement. This study uses a hybrid Type 1 multi-site randomized clinical trial (RCT) to assess BPC's effectiveness in settings in rural and urban populations. A total of 300 participants will be recruited, with outcomes such as parent well-being, and child safety, and well-being. Findings from this study will determine BPC's eligibility for inclusion in the Title IV-E Clearinghouse, expanding access to this evidence-based intervention within the U.S. child welfare system. In addition to enhancing access to parenting programs in underserved communities, the findings could inform global child welfare practices by illustrating how trauma-informed, culturally responsive interventions can be effectively implemented on an international scale.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107863"},"PeriodicalIF":2.0,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory","authors":"Lesley H. Curtis ,&nbsp;Stephanie Morain ,&nbsp;P. Pearl O'Rourke ,&nbsp;Karen Staman ,&nbsp;Jeffrey G. Jarvik ,&nbsp;Andrea Cheville ,&nbsp;Dana L. Dailey ,&nbsp;Kathleen A. Sluka ,&nbsp;Patrick Heagerty ,&nbsp;Edward R. Melnick ,&nbsp;Hrishikesh Chakraborty ,&nbsp;James A. Tulsky ,&nbsp;Angelo Volandes ,&nbsp;Gregory E. Simon","doi":"10.1016/j.cct.2025.107866","DOIUrl":"10.1016/j.cct.2025.107866","url":null,"abstract":"<div><div>The distinguishing characteristics of pragmatic clinical trials merits special attention when developing a monitoring plan. Pragmatic clinical trials are large in scope; participants are often identified from records or routinely collected data; investigators typically have less control over treatments or interventions; outcome data are often extracted from health records; and study activities are commingled with usual health care. We use lessons from The NIH Pragmatic Trials Collaboratory, which supports the conduct of 32 pragmatic clinical trials, to illustrate some of the challenges and solutions. Challenges include the complexity, quality, and timing of a real-world data pipeline; interventions that are embedded in clinical workflows; and the potential for incidental findings. We recommend regular, rigorous data quality checks, ongoing monitoring of adherence to interventions, and including someone who is knowledgeable about pragmatic clinical trials and novel research designs in the development of Data and Safety Monitoring Plans and Data and Safety Monitoring Boards. Close monitoring by study leaders, independent monitors or and Data and Safety Monitoring Boards is critical for a successful study that produces meaningful results. These experts must also decide about what evidence requires action and/or modification of the protocol and what information and thresholds would lead to a decision to pivot or terminate the trial.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107866"},"PeriodicalIF":2.0,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143511960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of informative censoring on estimation and testing in randomized trials with delayed treatment effects.","authors":"Jingyi Lin, Yujie Zhao, X Gregory Chen, Margarita Donica, Larry Léon, Ludovic Trinquart, Shuyan Sabrina Wan","doi":"10.1016/j.cct.2025.107860","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107860","url":null,"abstract":"<p><p>Time-to-event endpoints like progression-free survival in oncology randomized trials sometimes demonstrate differential censoring patterns between study arms which can be indicative of informative censoring, depending on censoring reasons. Informative censoring can bias treatment effect estimates but few simulation studies characterized the magnitude of its impact, particularly in the context of therapies with delayed treatment effects. We used copula methods to model dependent censoring data and assessed the impact of informative censoring. To improve the understanding of copula models in this context, we proposed a new measure of the strength of informative censoring, the probability of events being informatively censored. We further proposed a visual tool for examining the underlying correlation pattern between censoring and event time. We conducted simulation studies to assess the impact of informative censoring on estimation bias for hazard ratios, as well as on empirical power of unweighted, weighted log-rank tests, and the MaxCombo test. We implemented data generation algorithm for copula survival models with piece-wise exponential marginals to introduce various censoring patterns under scenarios with delayed treatment effect. We found large overestimation of hazard ratio of the experimental arm versus the control arm and loss in power when there was a positive correlation between event time and censoring time in the control arm and a negative correlation in the experimental arm. When correlations in both arms were of the same direction and degree, we observed minimal impact on hazard ratio estimate and statistical powers.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107860"},"PeriodicalIF":2.0,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing a multicomponent intervention to increase glucose time in range in adolescents and young adults with type 1 diabetes: An optimisation trial to screen continuous glucose monitoring, sleep extension, healthier snacking and values-guided self-management intervention components","authors":"Sara E. Styles ,&nbsp;Jillian J. Haszard ,&nbsp;Shelley Rose ,&nbsp;Barbara C. Galland ,&nbsp;Esko J. Wiltshire ,&nbsp;Martin I. de Bock ,&nbsp;Miriama Ketu-McKenzie ,&nbsp;Anna Campbell ,&nbsp;Jenny Rayns ,&nbsp;Ruth Thomson ,&nbsp;Jessica Wong ,&nbsp;Craig A. Jefferies ,&nbsp;Carmel E. Smart ,&nbsp;Benjamin J. Wheeler","doi":"10.1016/j.cct.2025.107864","DOIUrl":"10.1016/j.cct.2025.107864","url":null,"abstract":"<div><h3>Aim</h3><div>The study aimed to identify active intervention components to improve glucose sensor time in range (TIR; 70–180 mg/dL [3.9–10.0 mmol/L]) by ≥5 % among adolescents and young adults (13 to 20 yrs) with type 1 diabetes and above recommended glycated haemoglobin (HbA1c ≥ 7.5 % [≥ 58 mmol/mol]), regardless of current insulin therapy.</div></div><div><h3>Methods</h3><div>The 6-week optimisation trial used a 2⁴ factorial experiment to estimate the main effects and interactions of the following candidate intervention components on TIR: real-time continuous glucose monitoring (CGM) technology, sleep extension, healthier snacking support, and values-guided self-management. Twenty-one participants, mean (SD) age 16.1 (2.4) years, were randomised to one of 16 experimental conditions.</div></div><div><h3>Results</h3><div>The main effects, as measured by the mean difference (95 % CI) in TIR from baseline to 4 weeks, were: CGM, 3.3 (−8.8, 15.4) percentage points; sleep extension, −7.2 (−19.0, 4.6) percentage points; snacking support, 0.9 (−11.8, 13.5) percentage points; values-guided self-management, 6.1 (−7.5, 19.7) percentage points.</div></div><div><h3>Conclusions</h3><div>The values-guided self-management was the only ‘active’ component. Conclusions about the less impactful intervention components are limited due to disruptions in research activities from the COVID-19 pandemic. Future work will address other candidate intervention components.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107864"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and methods of a multi-level intervention to improve adherence to childhood cancer survivorship care by partnering with primary care providers: The BRIDGES randomized controlled trial","authors":"Wilhelmenia L. Ross ,&nbsp;Yaiomy Santiago-Rivera ,&nbsp;Ming T. Tan ,&nbsp;Megan M. Roy ,&nbsp;Stacy Bryant ,&nbsp;Burton E. Appel ,&nbsp;Jacqueline Casillas ,&nbsp;Jenna Demedis ,&nbsp;Andrew B. Smitherman ,&nbsp;Leora I. Horwitz ,&nbsp;Alejandra Hurtado-de-Mendoza ,&nbsp;Jason A. Mendoza ,&nbsp;Sheila J. Santacroce ,&nbsp;Nina S. Kadan-Lottick","doi":"10.1016/j.cct.2025.107859","DOIUrl":"10.1016/j.cct.2025.107859","url":null,"abstract":"<div><h3>Background</h3><div>Despite heightened risk of chronic health conditions, &lt;20 % of childhood cancer survivors (CCS) receive guideline-recommended surveillance for late effects. Barriers include avoidance of reminders, lack of knowledge, and costs. The goal of the BRIDGES Study is to evaluate the effects of a multi-level, remote intervention on adherence to guideline-recommended surveillance among CCS by partnering with primary care providers (PCPs).</div></div><div><h3>Methods</h3><div>This ongoing study is a multi-site, two-arm, prospective, parallel design, 1:1 randomized controlled non-inferiority trial (<em>N</em> = 240; <em>n</em> = 120/group). Eligibility criteria are: cancer diagnosis at age &lt; 21 years, 2.0–4.0 years post-cancer therapy, and no previous specialty survivorship clinic care. The intervention includes: 1) patient survivorship education via telehealth with a cancer center nurse, including discussion of patient's individualized survivorship care plan (SCP), 2) ongoing patient-tailored health education within the electronic health record's patient portal, 3) a structured interactive phone call between the cancer center nurse and PCP, including discussion of patient's SCP, and 4) an in-person PCP visit for survivorship care. Patients randomized to the comparison group are contacted to schedule an in-person visit at their cancer center-based survivorship clinic. Adherence to guideline-recommended surveillance tests (primary outcome) is assessed at 1-year post-randomization (primary follow-up time point) and 2-years post-randomization (for durability). Patient knowledge, self-efficacy, and activation; PCP knowledge and self-efficacy; and process outcomes are also assessed.</div></div><div><h3>Conclusion</h3><div>Models of survivorship care that overcome existing barriers are needed. If efficacious, this scalable, remote intervention would be a valuable strategy to address barriers and bridge gaps in care to reach more CCS.</div><div><strong>Clinical Trial Registration:</strong> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT05448560</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107859"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cognitive remediation in breast cancer survivors: A study protocol","authors":"Pedro Alejandro Rodriguez Nunez ,&nbsp;Véronique Gérat-Muller ,&nbsp;Carine Bellera ,&nbsp;Caroline Lalet ,&nbsp;Bruno Quintard ,&nbsp;Camille Chakiba ,&nbsp;Virginie Postal","doi":"10.1016/j.cct.2025.107858","DOIUrl":"10.1016/j.cct.2025.107858","url":null,"abstract":"<div><div>Cancer treatment-related cognitive impairment, also known as “Chemobrain,” is frequently reported among cancer survivors. This condition can persist for months after the end of cancer treatment and can affect various aspects of a patients' quality of life. Despite growing evidence, research into effective treatments remains an emerging field. This project aims to assess the effectiveness of a cognitive remediation protocol called Oncogite in reducing cancer treatment-related cognitive impairment. The primary outcomes are self-reported functional and emotional well-being. The secondary outcomes include measures of executive function (working memory, inhibition, shifting), episodic memory, perceived cognitive function and perceived quality of life. One hundred sixty-four breast cancer survivors will be recruited from an existing cohort. Patients will be randomized to either a cognitive remediation group or a no intervention group. Participation in the workshops will be via videoconferencing, led by a neuropsychologist. Patients in the experimental group will also have access to an internet platform with the exercises practiced between the group workshops. The intervention will last four months at a rate of one workshop per week. The following data will be collected: emotional and functional well-being, neurocognitive performance, switching, inhibition, cognitive complaints, episodic memory, fatigue and depression. We will conclude that the intervention is effective if there is 4-month improvement in both emotional and functional well-being to find in the experimental group in their cognitive functioning. This research will contribute to the development of new clinical tools for cancer treatment-related cognitive impairment and facilitate the return to work in cancer survivors.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107858"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people","authors":"Stephanie L. Fitzpatrick ,&nbsp;Jennifer Polo ,&nbsp;Patti Ephraim ,&nbsp;Elizabeth Vrany ,&nbsp;Codruta Chiuzan ,&nbsp;Melissa Basile ,&nbsp;Ciaran P. Friel ,&nbsp;Khatiya Chelidze Moon ,&nbsp;Emily Silvia ,&nbsp;Hallie Bleau ,&nbsp;Wanda Nicholson ,&nbsp;Dawnette Lewis","doi":"10.1016/j.cct.2025.107850","DOIUrl":"10.1016/j.cct.2025.107850","url":null,"abstract":"<div><h3>Background</h3><div>Black birthing people are disproportionately affected by severe maternal morbidity (SMM). The MOMs Chat &amp; Care Study (R01NR021134) is a pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model to facilitate timely, appropriate care for high-risk Black birthing people and reduce the risk for SMM.</div></div><div><h3>Methods</h3><div>We will recruit 674 adult, English and Spanish-speaking Black birthing people who are less than 17 weeks gestational age, considered high risk based on the Obstetrics-Comorbidity Index and/or history of preeclampsia, and receive care at a Northwell Health obstetric practice. Participants will be randomized to either MOMs High Touch or Low Touch. In both intervention arms participants will receive close monitoring via chatbot technology and navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods, Fitbit to track physical activity, and bi-weekly postpartum telehealth visits up to 6-weeks postpartum. MOMs High Touch will also receive 12 bi-weekly self-management support telehealth visits during pregnancy and a home blood pressure monitor. The two arms will be compared on incidence of SMM at labor and delivery (Aim 1), SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and treatment (Aim 2), perceived social support (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will be used to examine facilitators and barriers to intervention implementation (Aim 5).</div></div><div><h3>Conclusion</h3><div>Findings from this study will inform how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities.</div><div><strong>Registration of Clinical Trials</strong>: This trial is registered on <span><span>www.ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06335381</span><svg><path></path></svg></span>).</div><div><strong>Protocol version</strong>: 07/22/2024, 24–0131-NH.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107850"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143481831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The modified combo i3 + 3 design for novel-novel combination dose-finding trials in oncology.","authors":"Jiaxin Liu, Shijie Yuan, Qiqi Deng, Yuan Ji","doi":"10.1016/j.cct.2025.107857","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107857","url":null,"abstract":"<p><p>We consider a modified Ci3 + 3 (MCi3 + 3) design for dual-agent dose-finding trials in which both agents are tested on multiple doses. This usually happens when the agents are novel therapies. The MCi3 + 3 design offers a two-stage or three-stage version, depending on the practical need. The first stage begins with single-agent dose escalation, the second stage launches a model-free combination dose finding for both agents, and optionally, the third stage follows with a model-based design. MCi3 + 3 aims to maintain a relatively simple framework to facilitate practical application, while also address challenges that are unique to novel-novel combination dose finding. Through simulations, we demonstrate that the MCi3 + 3 design adeptly manages various toxicity scenarios. It exhibits operational characteristics on par with other combination designs, while offering an enhanced safety profile. The design is motivated and tested for a real-life clinical trial.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107857"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143481773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals","authors":"Kristin Klemmetsby Solli ,&nbsp;Jūratė Šaltytė Benth ,&nbsp;Linn Camilla Wergeland Digranes ,&nbsp;Line Holtan ,&nbsp;Nikolaj Kunoe ,&nbsp;Lars Tanum","doi":"10.1016/j.cct.2025.107861","DOIUrl":"10.1016/j.cct.2025.107861","url":null,"abstract":"<div><h3>Background</h3><div>Mental health status may be improved in patients receiving treatment with the opioid antagonist extended-release naltrexone (XR-NTX), but longer-term outcomes remain unexamined.</div></div><div><h3>Objectives</h3><div>This study aims to assess changes in symptoms of anxiety, depression, and insomnia among opioid-dependent individuals in long-term treatment with XR-NTX and to explore possible associations between such symptoms and the use of illicit opioids. Methods: After completing an initial 3-month randomized clinical trial and an extended 9-month follow-up study, 50 opioid-dependent individuals (9 women) chose to continue treatment with XR-NTX at their own discretion for a prolonged period of up to 2 years. Symptoms of anxiety, depression, and insomnia were assessed every 4th week. In addition, the participants reported use of illicit opioids.</div></div><div><h3>Results</h3><div>The participants reported improved mental health status during up to 3 years treatment with XR-NTX. Symptoms of anxiety and depression were reduced from mean 18.0 (SD:6.1) to 12.3 (SD:4.4) (<em>p</em> &lt; 0.001), and from 30.5 (SD:9.1) to 17.8 (SD:5.4) (<em>p</em> &lt; 0.01), respectively, whereas symptoms of insomnia were reduced from 14.2 (SD:7.9) to 3.6 (SD:3.6), (p &lt; 0.001). The reduction in these symptoms was more pronounced in participants who did not relapse to opioid use (<em>n</em> = 35) during the study.</div></div><div><h3>Conclusion</h3><div>Long-term treatment with XR-NTX may promote a reduction in symptoms of anxiety, depression, and insomnia in opioid-dependent individuals. Those who managed to stay abstinent from opioids were likelier to experience a greater reduction in symptoms compared to those who relapsed to opioid use during the 3-year treatment period.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> no. <span><span>NCT01717963</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107861"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}