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A trial to investigate the effects of Cannabidiol plus Naltrexone on alcohol craving in patients with alcohol dependence
EU CTIS ID: 2024-518164-12-00
What this study is testing
To assess the effect of either 800mg or 1200mg oral CBD in addition to background treatment with 50mg oral Naltrexone on the reduction of alcohol craving compared to the effects of a placebo in addition to standard treatment with 50mg oral Naltrexone.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.