A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence

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.

Conditions

• Alcohol Addiction
• Alcoholism

Interventions

DRUG

Cannabidiol capsules

800mg (trial arm 1) or 1200mg (trial arm 2) Cannabidiol capsules will be administered daily over the course of 14 days.

DRUG

Naltrexone (drug)

All participants will receive 50mg Naltrexone daily as oral tablet throughout the study.

DRUG

Placebo

Placebo capsules matching the cannabidiol capsules will be administered daily.

Sponsors & Collaborators

• Heidelberg University - Institute of Medical Biometry (IMBI)

  collaborator UNKNOWN

• Heidelberg University - Coordination Centre for Clinical Trials (KKS) of Heidelberg University

  collaborator UNKNOWN

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Central Institute of Mental Health, Mannheim

  lead OTHER

Principal Investigators

• Patrick Bach, Prof. Dr. Dr. · Central Institute of Mental Health, Mannheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-22

Primary Completion

2028-04-01

Completion

2028-09-30

Countries

• Germany

Study Locations