Cannabidiol plus naltrexone for reducing alcohol craving in adults with alcohol dependence
ICONICplus - Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Cue-Induced Alcohol Craving in Alcohol Dependence
This trial will test whether adding cannabidiol (CBD) to naltrexone, or using CBD alone, reduces alcohol craving in adults with alcohol dependence.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Central Institute of Mental Health, Mannheim Academic / other |
| Locations | 2 sites (Wiesloch, Baden-Wurttemberg and 1 other locations) |
| Trial ID | NCT06845124 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–70 with ICD-10 alcohol dependence who report alcohol craving, can give informed consent, and agree to required contraception measures if applicable are suitable candidates.
Not a fit: Patients with current psychotic or bipolar disorder, severe depressive episodes with suicidal ideation, current use of excluded medications (for example opioid-containing analgesics), pregnant or breastfeeding individuals, or those unable to comply with study visits are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the combination could better reduce alcohol craving and potentially lower relapse risk compared with current treatments.
How similar studies have performed: Small clinical studies have suggested CBD can reduce alcohol craving and preclinical studies indicate CBD plus naltrexone may act synergistically, but the specific combination has not yet been proven in randomized trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wiesloch, Baden-Wurttemberg and 1 other locations
- Psychiatric Centre North Baden (PZN) — Wiesloch, Baden-Wurttemberg, Germany (Not_yet_recruiting)
- Central Institute of Mental Health — Mannheim, Germany (Recruiting)
Study contacts
- Study coordinator: Patrick Bach, Prof. Dr. Dr.
- Email: patrick.bach@zi-mannheim.de
- Phone: +49-621-1703-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.