Wiesloch

Researchers are investigating alcohol addiction, a chronic and relapsing condition with limited treatment options, focusing on alcohol craving—a key symptom that often leads to relapse. This phase II randomized, double-blind, placebo-controlled trial evaluates the potential added benefit of the compound cannabidiol (CBD), combined with the approved medication naltrexone (NTX), on reducing alcohol craving in adults with alcohol dependence who experience high craving levels. The study also explores quality of life and biological markers related to craving as secondary outcomes and tracks follow-up data up to 196 days to assess long-term effects. Participants are randomly assigned to one of three groups: CBD 800 mg plus NTX 50 mg, CBD 1200 mg plus NTX 50 mg, or placebo plus NTX 50 mg. All treatments are administered daily over a 14-day period, embedded within a standardized addiction treatment program. CBD and matching placebo capsules are given orally alongside daily oral NTX tablets throughout the study. This design aims to test whether adding CBD to NTX reduces alcohol craving more effectively than NTX alone. During the study, participants undergo assessments of alcohol craving using the Obsessive Compulsive Drinking Scale at baseline and after 14 days of treatment, which serves as the primary outcome. Researchers also evaluate quality of life and collect neurobiological and biochemical samples related to craving. Follow-up evaluations occur at 28, 42, 105, and 196 days after treatment to understand the durability of treatment effects. Safety and adherence are monitored throughout the trial to ensure participant well-being.

Researchers are evaluating the effectiveness of maintenance electroconvulsive therapy (mECT) combined with clozapine treatment in patients with treatment-resistant schizophrenia who have responded to an initial course of ECT. Schizophrenia is a serious mental disorder, and about 15-30% of patients do not respond to standard antipsychotic treatments, including clozapine. This trial aims to determine if mECT can delay relapse and increase the number of relapse-free patients compared to clozapine treatment alone, potentially influencing future treatment guidelines. The study involves two phases: first, an acute ECT series to achieve significant clinical improvement, followed by a randomized, blinded phase where responders receive either clozapine alone or clozapine plus maintenance ECT. The trial plans to enroll 84 patients aged 18 to 75 years who have treatment-resistant schizophrenia. Treatment as usual is compared to the addition of mECT, which is delivered as a device-based therapy. Participants will be monitored over 28 weeks in phase II to measure time to relapse as the primary outcome. Secondary assessments include functioning, quality of life, depression, schizophrenia symptoms, catatonia, stress, self-stigmatization, and cognitive performance. The study includes follow-up visits and data analysis over several years, with the last patient completing a 12-month follow-up phase four years after study start.

Researchers are evaluating the use of transcranial direct current stimulation (tDCS) as an add-on treatment for individuals with substance use disorders, focusing on alcohol use disorder. The study aims to identify the best electrode placement and current direction to improve inhibitory control and reduce craving. This could potentially lead to longer abstinence periods and less substance use after relapse. The trial compares multiple active tDCS settings, a sham (placebo) stimulation, computerized inhibition training, and a control group receiving standard detoxification treatment. Participants receive tDCS sessions lasting 20 minutes each for five consecutive days, with electrodes placed using an EEG cap to ensure accuracy. Four active tDCS protocols and one sham stimulation are tested, along with two active control groups and one group without additional treatment. Computerized inhibition training using a Go/No-Go task with alcohol-related images is also performed. All participants undergo qualified detoxification treatment during the study. On the first day, participants complete psychometric tests, neuropsychological assessments, and EEG recordings during a Go/No-Go task before starting their assigned intervention. They continue their intervention on days 2 through 4 and receive a final session with EEG monitoring on day 5. Follow-up occurs by phone at 4, 8, and 24 weeks to track relapse and substance use, with an in-person EEG and assessment at 12 weeks. Outcome measures include inhibitory control performance, EEG activity, and craving levels throughout the study period.