A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence

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 symptomdefinition

• Ability of subject to understand character and individual consequences of theclinical 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, useof a highly effective birth control method until one month after last IMPadministration (see Appendix 1) and negative pregnancy test

Exclusion Criteria:

• Current psychotic or bipolar disorder or current severe depressive episode withsuicidal ideations

• Current treatment with any of the following substances: Any investigationalmedicinal 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, whenbeing taken in stable dose for a minimum of 14 days prior to enrolment and/ordoxepine 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] orepilepsy determined by medical history

• Patients with elevated transaminase levels (AST or ALT) above three times the upperlimit normal (ULN) value with elevated bilirubin levels above twice the ULN value

• History of hypersensitivity to the investigational medicinal product CBD and/orNaltrexone (trade names: Adepend, Naltrexon-Hcl neuraxpharm, NaltrexonhydrochloridAccord) or to any drug with similar chemical structure or to any excipient presentin the pharmaceutical form of the investigational medicinal product CBD and/orNaltrexone

• Participation in other clinical trials or observation period of competing clinicaltrials, respectively.

• Acute suicidal tendency or acute endangerment of self and others