NCT06845124 A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence
| NCT ID | NCT06845124 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Central Institute of Mental Health, Mannheim |
| Condition | Alcohol Addiction |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-07-22 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound for the treatment of alcohol craving in AD is Cannabidiol (CBD), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which is approved for AD treatment, due to the synergistic effects of the combination of Cannabidiol plus Naltrexone on alcohol consumption that were shown by preclinical studies. The proposed three-armed, 1:1:1 randomized, double-blind, placebo-controlled parallel group, multicentric phase II trial seeks to test the putative synergistic effects of combined CBD (800mg) + oral NTX (50mg) against CBD (1200mg) + oral NTX (50mg) against Placebo + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AD that suffer from high alcohol craving. The trial seeks to test the effects of the innovative combination of CBD plus NTX against Placebo plus NTX on alcohol craving over a 14-day treatment period, which is embedded in a standardized addiction treatment program according to current treatment guidelines, in order to estimate the added value of treatment with CBD on alcohol craving. Quality of life and neurobiological and biochemical markers for craving will serve as secondary outcomes, because they show strong associations to treatment outcome and relapse risk. Collection and analysis of follow-up data (28 days, 42 days, 105 days, 196 days) will be performed to determine whether treatment effects relate to patient outcome.
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
Contact & Investigator
Patrick Bach, Prof. Dr. Dr.
STUDY DIRECTOR
Central Institute of Mental Health, Mannheim
Frequently Asked Questions
Who can join the NCT06845124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Alcohol Addiction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06845124 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06845124 currently recruiting?
Yes, NCT06845124 is actively recruiting participants. Contact the research team at patrick.bach@zi-mannheim.de for enrollment information.
Where is the NCT06845124 trial being conducted?
This trial is being conducted at Wiesloch, Germany, Mannheim, Germany.
Who is sponsoring the NCT06845124 clinical trial?
NCT06845124 is sponsored by Central Institute of Mental Health, Mannheim. The principal investigator is Patrick Bach, Prof. Dr. Dr. at Central Institute of Mental Health, Mannheim. The trial plans to enroll 150 participants.
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