Alcohol dependence (AD) is highly prevalent and has severe consequences on health and quality of life. However, the efficacy of approved pharmacotherapies such as naltrexone (NTX) remains limited, highlighting the need for novel pharmacotherapeutic approaches. Cannabidiol (CBD) is a promising candidate, which has shown potential to reduce craving and alcohol use by modulating brain circuits involved in craving and addiction. Preclinical studies suggest that CBD may enhance NTX’s therapeutic effects.

This is a three-armed, randomised, double-blind, placebo-controlled parallel group, multicentre phase II clinical trial. A total of 150 patients with AD will be randomised (1:1:1) to receive either 800 mg or 1200 mg CBD plus 50 mg oral NTX or placebo plus 50 mg oral NTX for 14 days. Alcohol craving will be assessed using the Obsessive Compulsive Drinking Scale (OCDS-G) where the primary endpoint is the change from baseline to the end of treatment. Secondary outcomes include craving during the entire study, quality of life, depressive symptoms, anxiety, patient-reported outcomes, neural brain activation, CBD plasma levels, time to relapse, alcohol use and treatment safety. For the comparison of each experimental group to the control group, a strata-adjusted (centre and baseline OCDS-G) van Elteren test is applied with adjustment for multiple testing by Bonferroni-Holm.

The trial has been approved by the Ethics Committee and the competent authority (ID: B_03510). All participants will provide written informed consent. An independent Data and Safety Monitoring Board will monitor safety. This trial complies with national and international regulations.

NCT06845124; EU Trial Number: 2024-518164-12-00.

Neoadjuvant (chemo)radiotherapy (n(C)RT) followed by resection with total mesorectal excision (TME) constitutes the standard treatment for patients with locally advanced rectal cancer of the middle and lower third. However, n(C)RT has demonstrated no significant impact on overall survival but is associated with adverse effects, including impaired sphincter and sexual function. We hypothesise that omitting n(C)RT in selected patients with a clear circumferential resection margin (CRM) >1 mm as determined through preoperative MRI is not inferior regarding local recurrence rate within 3 years after surgery. That treatment approach may show fewer adverse effects and be more cost-effective.

Selective neoadjuvant therapy of rectal cancer patients (SELREC) is a randomised controlled, parallel-group, open, multicentre, non-inferiority trial. The experimental intervention involves performing TME surgery without n(C)RT. In contrast, the control intervention adheres to German S3-guidelines, incorporating neoadjuvant radiotherapy (nRT) with a dosage of 5x5 Gy or a total of 50.4 Gy. Additionally, if applicable, concomitant chemotherapy (CT) based on 5-fluorouracil is administered, followed by TME surgery within less than 12 weeks. Adjuvant treatment according to guidelines is allowed depending on the (y)pTNM stage.

The inclusion criteria for this study encompass adult patients with primary adenocarcinoma of the rectum in whom the main tumour mass is located less than 12 cm away from the anal verge, as assessed via proctoscopy. Additionally, eligible participants are required to have a preoperative tumour stage determined by MRI of either T1 or T2 with lymph node involvement (N1) or T3 with no lymph node involvement (N0) or with lymph node involvement (N1) and no distant metastases (M0). The assessment of a clear CRM >1 mm, based on MRI, is another prerequisite for inclusion. A total of 1074 patients in approximately 35 centres are planned to be allocated to the trial.

The primary endpoint of the trial is local recurrence within 3 years after surgery. The primary estimand is based on the full analysis set using a logistic mixed model (margin 3%). The first secondary endpoint is no/minor low anterior resection syndrome (LARS) score at 2 years after surgery, and further secondary endpoints include survival outcomes and quality of life. Safety analysis involves describing the frequencies of major intervention-specific complications, such as the acute toxicity of n(C)RT according to CTCAE and perioperative morbidity and mortality according to Clavien-Dindo criteria.

SELREC is financially supported by the German Federal Ministry of Education and Research.

This trial has been prospectively registered in the German Clinical Trials Register.

Previously, the study had been approved by the responsible ethics committee of Heidelberg and the local ethics committees of the collaborating institutions before patient enrolment. Any protocol deviation that has an impact on relevant parameters such as study design, endpoints or patient safety will be reported to the responsible ethics committees.

The results will be published in a peer-reviewed scientific journal and on institutional websites.

German Clinical Trials Register DRKS00030567.

Heated tobacco products (HTPs) are electronic devices that heat tobacco instead of burning it to produce an inhalable aerosol. This study aimed to investigate usage patterns, sociodemographic and socioeconomic factors, as well as co-use characteristics of people who use HTPs within the German population to inform interventions and preventive measures.

We conducted analysis with pooled cross-sectional data from the German Study on Tobacco Use (DEBRA) from June 2018 till November 2023. We estimated weighted, descriptive and bimonthly data on current and ever HTP usage and descriptive data on user patterns. To analyse the variance between people who ever versus people who never used HTPs in relation to user characteristics, we performed ² tests and calculated percentages and CIs.

The proportions of both people who currently use and people who ever used HTPs have increased from 2018 (current user: 0.1% [95%CI:

HTP use has increased in Germany, particularly among younger males in urban areas. Public health interventions should target these demographics, focusing on raising awareness about potential health risks. The ban on aroma components in Germany may reduce the appeal for new users. Continuous monitoring is essential to assess the long-term impact of HTPs.

Regular physical activity (PA) and good motor performance are essential for children’s physical and mental health. However, historical trends suggest that levels of PA and motor performance in children and adolescents are at a low point. The relationships between PA, motor performance, health and their respective determinants, as well as their individual development throughout childhood and adolescence, are not yet fully understood. Therefore, continuous monitoring of PA, motor performance and health is needed to identify vulnerable subpopulations and provide data for policy-makers and health promotion professionals. The Motorik Monitoring 2.0-Study aims to analyse the developmental, historical and periodic trends in motor performance and PA, as well as the underlying determinants, in children and adolescents in Germany.

A representative sample of children and adolescents aged 4–17 years is drawn across 195 sample points in Germany. The assessment, carried out by test instructors, includes (1) a PA questionnaire covering different settings, including determinants, (2) anthropometric measures, (3) fine and gross motor performance tests focusing on coordination, flexibility, strength and endurance, (4) 24 hours device-based measured physical behaviour by accelerometry for 1 week and (5) a health interview focusing on health behaviour, physical and mental health as well as socioeconomic status. In addition, external data may be linked to the study using geographical information systems (eg, area deprivation, access to sports facilities). Analyses will be conducted using mixed-effects models to account for the nationwide structure of the study.

Ethical approval was obtained from the Ethics Committee of the Karlsruhe Institute of Technology. Results will be published in open-access scientific journals and disseminated at congresses for scientists, policy-makers and stakeholders.

The study was registered in the NFDI4health database (https://csh.nfdi4health.de/resource/1034). The NFDI4health database is a central platform of the National Research Data Infrastructure for Personal Health Data. It is used to collect, manage and provide health data for scientific research and facilitates access to high-quality data for epidemiological and clinical studies.