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

Launched by CENTRAL INSTITUTE OF MENTAL HEALTH, MANNHEIM · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two medications, Cannabidiol (CBD) and Naltrexone (NTX), on reducing alcohol cravings in people who struggle with alcohol dependence. Alcohol dependence is a condition where individuals have a strong desire to drink alcohol, which can lead to relapse. The researchers believe that combining CBD with NTX might be more effective than using NTX alone, so they will compare three different groups: one receiving a low dose of CBD with NTX, another getting a higher dose of CBD with NTX, and a third group receiving a placebo (a substance with no active ingredients) along with NTX. The main goal is to see if the combination treatments can help reduce cravings over a 14-day period.

To participate in this trial, individuals need to be between 18 and 70 years old and diagnosed with alcohol dependence, specifically experiencing cravings for alcohol. They should be able to understand the trial's purpose and provide written consent to participate. It's important to note that certain individuals, such as those with severe mental health conditions, those currently using specific medications, or those who are pregnant or breastfeeding, may not be eligible to participate. Participants will follow a structured treatment program and will have their cravings, quality of life, and other health markers monitored throughout the study and in follow-up visits over several months.

Gender

ALL

Eligibility criteria

• 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