Actively Recruiting
A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence
Led by Central Institute of Mental Health, Mannheim · Updated on 2026-02-03
150
Participants Needed
2
Research Sites
166 weeks
Total Duration
On this page
Sponsors
C
Central Institute of Mental Health, Mannheim
Lead Sponsor
H
Heidelberg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosis of alcohol dependence according to ICD-10
- Experiencing alcohol craving as defined by ICD-10
- Ability to understand the study and its individual consequences
- Provided written informed consent before enrollment
- Agrees to random assignment
- For women of childbearing potential and males with partners of childbearing potential, use of effective birth control during the study and negative pregnancy test
You will not qualify if you...
- Current psychotic or bipolar disorder or severe depressive episode with suicidal thoughts
- Current treatment with investigational products or specified medications including opioid analgesics, anti-obesity drugs, anticonvulsants, certain antipsychotics, antidepressants (unless stable for 14 days), opioid cough/cold agents, systemic steroids, anti-craving or aversive medications, THC or CBD medications, antiretroviral drugs, xanthines, general anesthetics, Hypericum perforatum, or certain antibiotics
- Positive drug screening for amphetamines, opiates, cocaine, or barbiturates
- Pregnancy, lactation, or breastfeeding
- Severe liver cirrhosis (CHILD B or C) or epilepsy
- Elevated liver enzymes (AST or ALT) above 3 times normal with bilirubin above twice normal
- History of hypersensitivity to CBD, naltrexone, or related drugs or excipients
- Participation in other clinical trials or competing observational studies
- Acute suicidal risk or danger to self or others
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Psychiatric Centre North Baden (PZN)
Wiesloch, Baden-Wurttemberg, Germany, 69168
Not Yet Recruiting
2
Central Institute of Mental Health
Mannheim, Germany, 68159
Actively Recruiting
Research Team
P
Patrick Bach, Prof. Dr. Dr.
CONTACT
S
Sina Vetter, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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