Clinical Research Directory

Inclusion Criteria: * Age between 18 and 70 years * Patients meeting the diagnosis of an alcohol dependence according to the ICD-10 * Patients reporting alcohol craving as symptom of AD according to the ICD10 symptom definition * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrollment in the study) * Consent to random assignment * For women with childbearing potential (WOCBP) and males with partners with CBP, use of a highly effective birth control method until one month after last IMP administration (see Appendix 1) and negative pregnancy test Exclusion Criteria: * Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations * Current treatment with any of the following substances: Any investigational medicinal product, Opioid-containing Analgesics, Anti-obesity drugs, Anticonvulsants, Opioid-containing Antidiarrheal Agents, Antineoplastics, Antipsychotics (exception: episodic use of melperone, prothipendyl, pipamperone, promethazine and quetiapine are allowed), Antidepressants (exception: allowed, when being taken in stable dose for a minimum of 14 days prior to enrolment and/or doxepine in low doses \[max. 75mg daily\]), Opioid-containing Cough/cold agents, Systemical Steroids, Other anti-craving (e.g. Acamprosate) or aversive medication (e.g. disulfiram), THC- or CBD-containing medication, Antiretroviral medication (e.g., Efavirenz), Xanthines (e.g., Theophylline), General anesthetics (e.g., propofol), Hypericum perforatum, Antibiotics (e.g., Rifampin, Clarithromycin, Erythromycin) * Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates) * Pregnancy, lactation or breastfeeding * Current severe somatic comorbidities: severe liver cirrhosis \[CHILD B or C\] or epilepsy determined by medical history * Patients with elevated transaminase levels (AST or ALT) above three times the upper limit normal (ULN) value with elevated bilirubin levels above twice the ULN value * History of hypersensitivity to the investigational medicinal product CBD and/or Naltrexone (trade names: Adepend, Naltrexon-Hcl neuraxpharm, Naltrexonhydrochlorid Accord) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product CBD and/or Naltrexone * Participation in other clinical trials or observation period of competing clinical trials, respectively. * Acute suicidal tendency or acute endangerment of self and others