Actively Recruiting
Led by Central Institute of Mental Health, Mannheim · Updated on 2026-02-03
150
Participants Needed
2
Research Sites
26 weeks
Total Duration
C
Central Institute of Mental Health, Mannheim
Lead Sponsor
H
Heidelberg University
Collaborating Sponsor
Researchers are investigating the effects of combining Cannabidiol (CBD) with Naltrexone (NTX) on alcohol craving in people with alcohol dependence, a chronic condition with limited treatment options. This phase II, randomized, double-blind, placebo-controlled trial aims to evaluate whether two different doses of CBD (800mg and 1200mg), when added to standard NTX treatment (50mg daily), reduce alcohol craving more than NTX alone over a 14-day treatment period. The study focuses on patients who experience high alcohol craving and includes assessments of quality of life and biological markers related to craving as secondary outcomes. Participants will be randomly assigned to one of three groups: one receiving 800mg CBD plus 50mg NTX daily, another receiving 1200mg CBD plus 50mg NTX daily, and a third receiving placebo capsules plus 50mg NTX daily. All treatments are given orally during an inpatient addiction treatment program following current guidelines. The 14-day treatment period is part of a standardized care program, designed to evaluate the added effect of CBD on top of NTX. During the study, participants will be assessed at multiple visits including baseline, during treatment (days 1, 7, and 14), and follow-up visits at days 28, 42, 105, and 196. Researchers will measure alcohol craving using the Obsessive Compulsive Drinking Scale, along with quality of life, depression, anxiety, patient-reported outcomes, blood CBD levels, brain imaging, and drinking behavior. Safety is monitored through reports of adverse events. These evaluations aim to understand the treatment impact on craving and long-term outcomes over about seven months.
CONDITIONS
A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive daily oral treatment with 50mg Naltrexone combined with either 800mg or 1200mg Cannabidiol capsules or matching placebo capsules during in-patient treatment.
3 visits during treatment (day 1, day 7, and day 14)
Duration - Up to 182 days after treatment
Participants are monitored for alcohol craving, quality of life, depressive symptoms, adverse events, and alcohol consumption after treatment ends.
4 follow-up visits (day 28, day 42, day 105, and day 196) and weekly assessments during this period
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
P
Patrick Bach, Prof. Dr. Dr.
S
Sina Vetter, M.Sc.
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Sina Vetter, Julia Weinberg, Bettina C Thomas...
https://pubmed.ncbi.nlm.nih.gov/40803733