Recruiting

ICONICplusCannabidiol and Naltrexone for Alcohol Craving in Alcohol Dependence

What is being tested

Cannabidiol capsules

+ Naltrexone (drug)

+ Placebo

Drug

Who is being recruted

Alcoholism+2

+ Mental Disorders

+ Substance-Related Disorders

From 18 to 70 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorCentral Institute of Mental Health, Mannheim

Study ContactPatrick Bach, Prof. Dr. Dr.More contacts

Last updated: February 4, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 22, 2025

Actual date on which the first participant was enrolled.

This study is focused on finding better ways to help people who struggle with alcohol addiction, particularly those who experience strong urges to drink, known as alcohol cravings. Current treatments do not fully address these cravings, leading to possible relapses. Researchers are exploring the combination of two drugs, Cannabidiol (CBD) and Naltrexone (NTX), to see if they work better together than existing treatments. CBD has shown promise in reducing cravings in preliminary studies, while NTX is an established treatment for alcohol dependence. By testing these drugs together, the study aims to find a more effective method for reducing cravings and improving patients' quality of life. Participants in this study are divided into three groups: one receiving CBD and NTX, another receiving a higher dose of CBD with NTX, and the third receiving a placebo with NTX. The treatments are given orally over a 14-day period, as part of a standard addiction treatment program. The primary focus is to assess how well these combinations reduce alcohol cravings. Additionally, researchers will observe secondary factors like quality of life and biological markers related to cravings, which are indicators of treatment success and relapse risks. Follow-up data will be gathered at multiple points up to 196 days to evaluate the long-term impact of these treatments on patient outcomes.

Official TitleICONICplus - Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Cue-Induced Alcohol Craving in Alcohol Dependence

NCT06845124

Principal SponsorCentral Institute of Mental Health, Mannheim

Study ContactPatrick Bach, Prof. Dr. Dr.More contacts

Last updated: February 4, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlcoholismMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced Disorders

Criteria

7 inclusion criteria required to participate

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

Show More Criteria

9 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

All patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the experimental group of trial arm 2, patients will receive a dose of 1200mg Cannabidiol (CBD) daily over the course of 14 days during in-patient treatment.

Group II

Experimental

All patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the experimental group of trial arm 1, patients will receive a dose of 800mg Cannabidiol (CBD) daily over the course of 14 days during in-patient treatment.

Group III

Active Comparator

All patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the comparator group of trial arm 3, patients will receive placebo capsules daily over the course of 14 days during in-patient treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Central Institute of Mental Health

Mannheim, GermanyOpen Central Institute of Mental Health in Google Maps

Recruiting soon

Psychiatric Centre North Baden (PZN)

Wiesloch, Germany

Recruiting

2 Study Centers