Cannabidiol plus naltrexone for reducing alcohol craving in adults with alcohol dependence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial randomizes participants 1:1:1 to receive either CBD 800 mg plus oral naltrexone 50 mg, CBD 1200 mg alone, or placebo. Adult patients aged 18–70 with ICD-10 alcohol dependence who report alcohol craving are enrolled at several German psychiatric centers. Participants receive blinded study medication and are followed with measures of alcohol craving and related clinical outcomes. The trial is designed to determine whether CBD alone or in combination with naltrexone reduces craving more than placebo.

Why it matters

Who can join: the full rules

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

Where it's running

• Central Institute of Mental Health
  Mannheim, Germany Recruiting
• Psychiatric Centre North Baden (PZN)
  Wiesloch, Baden-Wurttemberg, Germany Not yet recruiting

Study contacts

• Study coordinator: Patrick Bach, Prof. Dr. Dr.
• Email: patrick.bach@zi-mannheim.de
• Phone: +49-621-1703-0

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.