Contemporary clinical trials最新文献

{"title":"The generalized 3+3 (G3) design for Phase I trials: A design for clinicians","authors":"Yuan Ji ,&nbsp;Yunxuan Zhang ,&nbsp;Andrew Ji ,&nbsp;Shivaani Kummar","doi":"10.1016/j.cct.2025.108077","DOIUrl":"10.1016/j.cct.2025.108077","url":null,"abstract":"<div><h3>Purpose</h3><div>To construct a simple and software-free dose-finding design that perform comparable to modern designs relying on statistical models.</div></div><div><h3>Methods</h3><div>The Generalized 3 + 3 (G3) design uses a set of arithmetic rules that depend on the number of participants enrolled and the number experiencing dose-limiting toxicity (DLT). Computer simulations are conducted based on a set of scenarios published in the literature and adopted by FDA.</div></div><div><h3>Results</h3><div>The G3 design provides identical decisions to 3 + 3 for 3 and 6 participants, and highly similar ones to modern designs. It performs better in selecting the MTD and patient allocation than 3 + 3 and comparable to modern designs. However, modern designs rely on specialized software while the G3 design can be generated by hand.</div></div><div><h3>Conclusion</h3><div>The G3 design extends the widely used 3 + 3 design by enabling flexible decision-making for any number of participants enrolled at a dose level. The G3 design is straightforward, transparent, and can be implemented without specialized software—making it an ideal option for clinicians.</div></div><div><h3>Limitation</h3><div>The G3 design is for classical dose-finding trials based on toxicity outcome. Modern therapeutics may rely on additional outcomes like efficacy or pharmacodynamic effects to define optimal doses.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108077"},"PeriodicalIF":1.9,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063486","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":"TeleHealth resistance exercise intervention to preserve dose intensity and vitality in elder breast Cancer patients (THRIVE 65)","authors":"Kathryn H. Schmitz ,&nbsp;Nathan A. Berger ,&nbsp;Cynthia Owusu ,&nbsp;Cynthia A. Thomson ,&nbsp;Vernon M. Chinchilli ,&nbsp;Karen Basen-Engquist ,&nbsp;William J. Evans ,&nbsp;John J. Pink ,&nbsp;Erica A. Schleicher ,&nbsp;Chao Cao ,&nbsp;Shawna E. Doerksen ,&nbsp;Jenna D. Binder ,&nbsp;Michele D. Sobolewski ,&nbsp;Anna M. Tanasijevic ,&nbsp;Kaedryn A. Diguglielmo ,&nbsp;Truong L. Nguyen ,&nbsp;Carissa A. Mills ,&nbsp;Wendy Kemp ,&nbsp;Jay B. Oppenheim ,&nbsp;Jennifer A. Ligibel","doi":"10.1016/j.cct.2025.108074","DOIUrl":"10.1016/j.cct.2025.108074","url":null,"abstract":"<div><h3>Background</h3><div>Older women with breast cancer are more likely than younger women to experience dose-limiting toxicities with chemotherapy. This leads to dose reduction, treatment discontinuation, and inferior treatment outcomes. Older women are also at higher risk of long-term detrimental impacts of treatment on quality of life and physical function.</div></div><div><h3>Aim</h3><div>The primary aim of the TeleHealth Resistance exercise Intervention to preserve dose intensity and Vitality in Elder breast cancer patients (THRIVE-65) trial is to assess the effects of an exercise and nutrition intervention on chemotherapy relative dose intensity among women aged ≥65 receiving chemotherapy for early-stage breast cancer.</div></div><div><h3>Methods/Design</h3><div>THRIVE-65 is a 2-arm parallel-group randomized controlled trial. The intervention includes two 30–45 min telehealth delivered resistance exercise sessions weekly, 90 min of unsupervised aerobic exercise weekly, and dietitian-guided high protein intake (1.2 g/kg/day)) delivered throughout the course of chemotherapy. The Health Education and Support control group receives a tablet with supportive care materials. Planned and observed chemotherapy dose and treatment schedule are recorded to assess relative dose intensity. Pre- and post- intervention assessments include patient reported outcomes, a geriatric assessment, dietary and physical activity measures, physical function and body composition.</div></div><div><h3>Conclusions</h3><div>The THRIVE-65 trial is poised to answer a crucial scientific question: Can exercise and nutrition support improve chemotherapy tolerance among older breast cancer patients? Study results will inform clinical practice related to exercise and nutrition support for this population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108074"},"PeriodicalIF":1.9,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063479","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 of RESOLVE Lung, a multinational Phase 2, randomized, placebo-controlled trial of the anti-GM-CSF monoclonal antibody namilumab in patients with chronic pulmonary sarcoidosis","authors":"Bernt van den Blink ,&nbsp;Chantal M. Petit ,&nbsp;Hayes M. Dansky ,&nbsp;Min Lin ,&nbsp;Marlies S. Wijsenbeek-Lourens ,&nbsp;Surinder S. Birring ,&nbsp;Robert P. Baughman ,&nbsp;Theodore F. Reiss","doi":"10.1016/j.cct.2025.108078","DOIUrl":"10.1016/j.cct.2025.108078","url":null,"abstract":"<div><h3>Background</h3><div>Pulmonary sarcoidosis is a rare inflammatory disease associated with morbidity and mortality. In light of limited treatment options, oral corticosteroids (OCS), off-label immunosuppressive therapies (IST) and tumor necrosis factor alpha inhibitors are standard of care. However, due to tolerability concerns with long-term use of OCS and IST, novel treatment options are needed. Namilumab is a potent, investigational granulocyte macrophage colony-stimulating factor humanized monoclonal antibody, that can potentially downregulate the granulomatous response, with favorable tolerability observed across clinical studies.</div></div><div><h3>Study design</h3><div>In this double-blind, 26-week, placebo-controlled trial, with an optional 28-week, open-label extension, approximately 100 patients will be randomized in a 1:1 ratio to receive 150 mg namilumab or placebo via subcutaneous injection. Eligible patients have active, chronic pulmonary sarcoidosis (CPS; assessed by clinical and radiologic parameters) poorly regulated by OCS and/or ISTs or failed or intolerant to treatment. At randomization, ISTs will be stopped and OCS tapered.</div></div><div><h3>Objective</h3><div>The objective of this trial is to evaluate the efficacy and safety of namilumab in patients with active CPS. The primary endpoint is the proportion of patients requiring rescue treatment during the double-blind period due to worsening sarcoidosis. Secondary endpoints include assessment of lung function, respiratory symptoms, and corticosteroid burden. Additionally, quality-of-life assessments, serum biomarkers, and a composite clinical benefit endpoint will be explored.</div></div><div><h3>Discussion</h3><div>This study will be one of the largest Phase 2 trials in the last decade for active CPS. Data from this trial will potentially provide valuable insights into disease endpoints, patient selection, and optimizing trial design.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108078"},"PeriodicalIF":1.9,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145052169","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":"Sleep coach intervention for adolescents with type 1 diabetes: Rationale and trial design","authors":"Sarah S. Jaser ,&nbsp;Jill Simmons ,&nbsp;Lauren L. Milner ,&nbsp;Charity E. Davis ,&nbsp;Samantha M. Davis ,&nbsp;Tabitha C. McCarty ,&nbsp;Lauren LeStourgeon ,&nbsp;Beth A. Malow ,&nbsp;James C. Slaughter ,&nbsp;Kashope Anifowoshe ,&nbsp;Lori C. Jordan","doi":"10.1016/j.cct.2025.108079","DOIUrl":"10.1016/j.cct.2025.108079","url":null,"abstract":"<div><h3>Background</h3><div>Despite improvements in hemoglobin A1c among adolescents with type 1 diabetes (T1D) over the past several years, most are still not meeting recommended glycemic targets, placing them at elevated risk for acute and long-term health complications. Thus, there is a critical need for novel approaches to improve diabetes management in adolescents with T1D. Insufficient and inconsistent sleep affects glycemic outcomes directly through decreased insulin sensitivity, and indirectly via compromised executive function in adolescents, reducing their ability to effectively manage T1D. Via a randomized controlled trial of 150 adolescents (age 11–17 years) with T1D, we will evaluate the effects of a sleep-promoting behavioral intervention that includes individual coaching on sleep duration and timing. We hypothesize that adolescents randomized to the Sleep Coach intervention will exhibit significantly longer sleep duration and reduced sleep variability as compared to those who receive enhanced usual care, consisting of additional diabetes education materials and text messages. Effects of the sleep-promoting intervention on executive function, glycemic outcomes (hemoglobin A1c, Time in Range) and diabetes management will be evaluated.</div></div><div><h3>Methods</h3><div>Primary outcomes (sleep duration and timing) and secondary outcomes (executive function, assessed with NIH Toolbox measures and caregiver reports, and glycemic outcomes) are assessed over 12 months. Intent-to-treat analysis will be used to evaluate efficacy of the intervention.</div></div><div><h3>Conclusion</h3><div>If efficacious, Sleep Coach has the potential to improve both cognitive and glycemic outcomes in adolescents with T1D. This individualized, interactive, manualized behavioral intervention can be delivered remotely by trained staff, with the potential for wide dissemination.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108079"},"PeriodicalIF":1.9,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145045589","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":"Testing the efficacy and mechanisms of an SMS intervention focused on motivating peer network support to reduce alcohol consumption in non-collegiate young adults: Protocol for a randomized trial","authors":"Brian Suffoletto ,&nbsp;Michael Mason ,&nbsp;Christine M. Lee ,&nbsp;Haley Hedlin","doi":"10.1016/j.cct.2025.108070","DOIUrl":"10.1016/j.cct.2025.108070","url":null,"abstract":"<div><h3>Background</h3><div>Non-collegiate young adults engage in high rates of heavy drinking but are less likely to access alcohol-related counseling or treatment. Peers play a significant role in shaping drinking behavior, yet few interventions target close peer influence in this population.</div></div><div><h3>Methods</h3><div>This two-arm randomized controlled trial will enroll 300 young adults aged 18–25 who report 2+ heavy drinking days (HDD; defined as 4+ drinks for a woman and 5+ drinks for a man) in the past 30 days and are not enrolled in college. Participants are randomized (1:1) to receive either (1) an SMS intervention focused on self-monitoring and goal-related strategies (i.e. Commitment-based Binge drinking prevention Intervention: CBI) or (2) ASPIRE, which adds feedback on peer influences and encouragement for positive support. Outcomes are assessed via REDCap-administered surveys at baseline, 3, 6, and 12 months. Additional data include twice-weekly SMS assessments during the 3-month intervention period and GPS-based mobility tracking with simultaneous ecological momentary assessment (EMA) during 7-day windows following each assessment time point. The primary outcome is number of heavy drinking days (HDD) in the past 30 days. Mediation analyses will assess cognitive, social, and environmental mechanisms of change using multilevel structural equation modeling.</div></div><div><h3>Discussion</h3><div>This trial advances the science of digital interventions for alcohol harm reduction in a high-risk and underserved population. ASPIRE is among the first interventions to integrate encouragement for positive peer network support into a scalable mobile platform. The use of high-frequency behavioral and geolocation data allows for novel insights into mechanisms of change.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108070"},"PeriodicalIF":1.9,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145026854","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":"Transdisciplinary care intervention for young adults with type 1 diabetes transitioning to adult healthcare: Rationale and trial design","authors":"Jessica S. Pierce ,&nbsp;Nicole Morales ,&nbsp;Melissa A. Alderfer ,&nbsp;Kamyar Arasteh ,&nbsp;Shilpa Gurnurkar","doi":"10.1016/j.cct.2025.108073","DOIUrl":"10.1016/j.cct.2025.108073","url":null,"abstract":"<div><div>There is a critical need for efficacious interventions targeting the psychosocial and systems level barriers to successful healthcare transitions in young adults (YA) with type 1 diabetes (T1D). Transdisciplinary Care for Transition (TCT) is a novel intervention that involves conjoint delivery of T1D care by a diabetes nurse educator, social worker/transition navigator, and psychologist during the transition between pediatric and adult T1D healthcare settings. The TCT team will participate in cross discipline training, see YA jointly for three 60-min virtual visits, and collaborate in care delivery by integrating their respective knowledge and skills. The goal of TCT is to improve healthcare utilization, transition readiness and success, and diabetes outcomes in YA with T1D. We will recruit 80 YA with T1D to participate in a randomized pilot trial with two arms: 1) usual care control; and 2) TCT. We will collect healthcare utilization data, patient-reported outcomes, and glycemic levels at baseline and 6 and 12 months later. We aim to examine the feasibility, acceptability, fidelity, and initial efficacy of TCT compared to usual care in YA with T1D. This paper describes the rationale, trial design, and methodology of the TCT study.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108073"},"PeriodicalIF":1.9,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145010380","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":"Phase 2C clinical trial of novel short-course regimens for the treatment of pulmonary tuberculosis: TBTC study 38/CRUSH-TB design","authors":"Ekaterina V. Kurbatova ,&nbsp;Kelly E. Dooley ,&nbsp;Wendy Carr ,&nbsp;Jason E. Stout ,&nbsp;Eric L. Nuermberger ,&nbsp;Patrick P.J. Phillips ,&nbsp;Nigel A. Scott ,&nbsp;Caryn M. Upton ,&nbsp;Elisa Ignatius ,&nbsp;Michelle Haas ,&nbsp;Nicholas D. Walter ,&nbsp;Rita M. Traxler ,&nbsp;Nicole E. Brown ,&nbsp;Rosanna Boyd ,&nbsp;Kia E. Bryant ,&nbsp;Meredith G. Dixon ,&nbsp;Rada Savic ,&nbsp;Christie Eichberg ,&nbsp;Anneke Hesseling ,&nbsp;Charles Bark ,&nbsp;Daniel W. Fitzgerald","doi":"10.1016/j.cct.2025.108075","DOIUrl":"10.1016/j.cct.2025.108075","url":null,"abstract":"<div><h3>Introduction</h3><div>Preclinical and clinical study data show that combining bedaquiline (B or BDQ), moxifloxacin (M), and pyrazinamide (Z), known as BMZ, has potent antimicrobial activity that might shorten treatment duration for drug-susceptible pulmonary tuberculosis.</div></div><div><h3>Methods/Design</h3><div>We describe the design of Tuberculosis Trials Consortium (TBTC) Study 38/CRUSH-TB (<span><span>NCT05766267</span><svg><path></path></svg></span>), an open-label multicenter international randomized controlled phase 2C trial that compares two four-month regimens, BMZ plus rifabutin (Rb) (2BMZRb/2BMRb) or BMZ plus delamanid (D or DLM) (2BMZD/2BMD), with standard 6-months isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE). All drugs are administered seven days per week, under direct observation, at least five days per week. A total of 288 participants, aged ≥12 years, newly diagnosed with sputum smear-positive or Xpert MTB/RIF (Ultra)-positive drug-susceptible pulmonary tuberculosis, will be randomized 1:1:1 to receive BMZRb, BMZD, or HRZE. Participants are followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first. The primary endpoint is time to sputum culture negative in liquid media. Secondary endpoints include sustained cure, safety, and additional mycobacteriology and pharmacokinetic and pharmacodynamic outcomes. This trial has an adaptive design, wherein new arms can be added.</div></div><div><h3>Discussion</h3><div>This trial tests the hypothesis whether four-month BMZ-based regimens with Rb or D can shorten time to culture negativity while being safe and tolerable for participants. The study design is adaptive, allowing for additional study arms as new drugs become available. Findings from this trial might have important implications for clinically managing drug-susceptible pulmonary tuberculosis at individual and programmatic levels.</div><div>Trial registration</div><div><strong>IND Number:</strong> 158058.</div><div><strong>IND Sponsor:</strong> U.S. Centers for Disease Control and Prevention.</div><div><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span> <strong>Identifier:</strong> <span><span>NCT05766267</span><svg><path></path></svg></span>. Registered 13 March 2023, <span><span>https://classic.clinicaltrials.gov/ct2/show/NCT05766267</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108075"},"PeriodicalIF":1.9,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145014039","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":"Assessing the feasibility, acceptability, and efficacy of a pragmatic pilot and full-scale trial to improve care for older adults with complex care needs: The SPIRE study.","authors":"Thomas Travison, Edward Pham, Karen Donelan, Stephen Bartels, Jocelyn Carter, Katie Corelli, Steven Counsell, Carie U Michael, Maggie Crean, Ellen Flaherty, Harvey Murff, Jen Perloff, Christine S Ritchie","doi":"10.1016/j.cct.2025.108072","DOIUrl":"https://doi.org/10.1016/j.cct.2025.108072","url":null,"abstract":"<p><p>Older adults with complex health and social care needs comprise some 5 % of the United States population but contribute to roughly half of healthcare costs. Patient and caregiver perspectives in qualitative studies emphasize care fragmentation in traditional care delivery models. The need for more streamlined and personalized care for these older adults is acute, particularly in value-based care systems such as Accountable Care Organizations (ACOs). Prior studies suggest that older adults with complex health needs are best cared for through person-centered care plans conducted by interdisciplinary teams of healthcare professionals, but adoption remains suboptimal. In this study, we compare two different geriatric-focused approaches to care for older adults: Annual Wellness Visits (AWV) and/or AWV augmented with GRACE (Geriatric Resources for Assessment and Care of Elders). AWVs are a Medicare benefit with a brief geriatric assessment; GRACE is a geriatric model of care that uses a home-based geriatric assessment, structured protocols, team-based care planning and primary care co-management to support older adults with complex care needs. The two-phase study includes a Phase 1 feasibility pilot, conducted in two primary care practices in one health system; and a Phase 2 cluster-randomized trial conducted in 32 primary care practices in four ACOs. Phase 2 assesses the comparative effectiveness of AWVs vs. AWV with GRACE, with primary outcomes of hospitalizations and patient experience, and secondary outcomes of caregiver strain and clinician professional fulfillment. Results will help inform personalized care among older adults with complex health needs. NCT06287801.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108072"},"PeriodicalIF":1.9,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999810","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":"Evaluating the effect of cannabidiol on sleep quality in patients with multiple sclerosis using 15 aggregated N-of-1 trials: A study protocol","authors":"Bo A.D.F. Saals ,&nbsp;Renger F. Witkamp ,&nbsp;Anne Claire B. van Orten-Luiten ,&nbsp;Heleen A. Kuijper-Tissot van Patot ,&nbsp;Lonneke M. van der Meijden-Erkelens ,&nbsp;Angelique Pijpers ,&nbsp;Sebastiaan Overeem ,&nbsp;Jop P. Mostert","doi":"10.1016/j.cct.2025.108071","DOIUrl":"10.1016/j.cct.2025.108071","url":null,"abstract":"<div><h3>Background</h3><div>Sleep disorders, including insomnia, are highly prevalent in individuals with multiple sclerosis (MS), significantly impacting quality of life. Patients frequently use cannabidiol (CBD) as an alternative to standard medical treatments for sleep disorders, yet its efficacy has not been rigorously investigated.</div></div><div><h3>Methods</h3><div>This study comprises 15 randomized, placebo-controlled N-of-1 trials evaluating the effect of pure CBD oil (10 % g/v) on sleep quality in MS patients. Each N-of-1 study consists of a two-week run-in period, followed by four treatment periods of three weeks, separated by a one-week washout. Participants receive both CBD and placebo twice in a randomized order. Treatment starts at 150 mg daily, increasing to 300 mg from week 2. Study outcomes are assessed during the final two weeks of each block. The primary outcome is sleep quality, measured by the Insomnia Severity Index (ISI). Secondary outcomes include patient-reported outcome measures of sleep recorded in a sleep-wake diary, and scores on the Checklist Individual Strength Fatigue-subscale (CIS-F), the Fatigue Severity Scale (FSS), and the Epworth Sleepiness Scale (ESS). Additionally, as a continuous proxy for fatigue, smartphone keyboard interactions will be collected using the Neurokeys application. Results from the individual N-of-1 trials will be aggregated for group-level analyses.</div></div><div><h3>Discussion</h3><div>This study aims to provide insight into the effects of a controlled CBD product on sleep quality in MS patients through an N-of-1 trial design. Given the substantial variability in sleep quality and the anticipated interindividual differences in CBD response, an N-of-1 design is considered a suitable methodological approach.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108071"},"PeriodicalIF":1.9,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999813","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 the economic evaluation of the \"Healthy for Two/Healthy for You\" pragmatic lifestyle intervention in prenatal care to reduce gestational weight gain and gestational diabetes mellitus.","authors":"Emmanuel F Drabo, Christine D McKinney, Lindsay M Martin, Divya Nair, Janelle W Coughlin, Tianxu Chen, Mostafa A Borahay, Nae-Yuh Wang, Wendy L Bennett","doi":"10.1016/j.cct.2025.108037","DOIUrl":"10.1016/j.cct.2025.108037","url":null,"abstract":"<p><strong>Background: </strong>Despite policymakers' demand for evidence of value and sustainability for scaling and implementing interventions, few studies have assessed the cost-efficiency and financial viability of lifestyle interventions for managing gestational weight gain and reducing gestational diabetes OBJECTIVES: To describe our methodological approach for assessing the cost-effectiveness and return-on-investment (ROI) of the pragmatic (i.e., integrated into real-world prenatal care) Healthy for Two / Healthy for You (H42/H4U) lifestyle intervention versus the usual prenatal care comparison arm, using a trial-based health economic evaluation METHODS: Data from the 36-month randomized clinical trial and electronic health records will be used to estimate the intervention's effectiveness (difference in total gestational weight gain [lbs]) and its associated incremental costs. ROI and cost-effectiveness analyses will be conducted from a U.S. payer's perspective. Costs will include recruitment, intervention delivery via health coaches and an online platform, and downstream expenses. ROI and incremental cost-effectiveness ratio (ICER) will assess financial viability and cost-efficiency, respectively. Sensitivity analyses will assess the impact of variability in effectiveness and costs on the ROI and ICER DISCUSSION: Our comprehensive methodological approach for evaluating the cost-effectiveness and financial viability of the pragmatic H42/H4U lifestyle intervention integrated into prenatal care aims to address gaps in health economic evidence and support future investment decisions. Ultimately the goal is to promote the successful implementation and uptake of lifestyle interventions for improving maternal health, preventing obesity and chronic disease TRIAL REGISTRATION: The clinical trial associated with this protocol paper is registered on ClinicalTrials.gov (NCT04724330). First posted on January 26, 2021.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108037"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768440","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}