Condition: Alcohol Addiction · Alcoholism · Sponsor: Central Institute of Mental Health, Mannheim
Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound for the treatment of alcohol craving in AD is Cannabidiol (CBD), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which is approved for AD treatment, due to the synergistic effects of the combination of Cannabidiol plus Naltrexone on alcohol consumption that were shown by preclinical studies. The proposed three-armed, 1:1:1 randomized, double-blind, placebo-controlled parallel group, multicentric phase II trial seeks to test the putative synergistic effects of combined CBD (800mg) + oral NTX (50mg) against CBD (1200mg) + oral NTX (50mg) against Placebo + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AD that suffer from high alcohol craving. The trial seeks to test the effects of the innovative combination of CBD plus NTX against Placebo plus NTX on alcohol craving over a 14-day treatment period, which is embedded in a standardized addiction treatment program according to current treatment guidelines, in order to estimate the added value of treatment with CBD on alcohol …
This description comes directly from the study's public registry record.
Patrick Bach, Prof. Dr. Dr. · +49-621-1703-0 · patrick.bach@zi-mannheim.de
Sina Vetter, M.Sc. · +49-621-1703-0 · Sina.Vetter@zi-mannheim.de
Always discuss trial participation with your own doctor first.
| Psychiatric Centre North Baden (PZN) | Wiesloch, Baden-Wurttemberg, Germany | Not Yet Recruiting |
| Central Institute of Mental Health | Mannheim, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06845124