ICONICplus - Randomized, double-blind, placebo-controlled trial to investigate the Effects of Cannabidiol plus Naltrexone on Cue-Induced Alcohol Craving in Alcohol Dependence

Eligibility criteria

• ['Age between 18 and 70 years', 'Patients meeting the diagnosis of an alcohol dependence according to the ICD10', 'Patients reporting alcohol craving as symptom of AD according to the ICD10 symptom definition', 'Ability of the individual to understand the character and the 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 childbearing potential (CBP), use of a highly effective birth control method until one month after last IMP administration and negative pregnancy test at the time of enrolment'] ['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 [stage: CHILD B or C]. epilepsy determined by medical history or prolonged or shortened QT intervals [determined by ECG]', 'Patients with elevated transaminase levels (GOT or GPT) 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']