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Study on the Effects of Cannabidiol and Naltrexone on Alcohol Craving in Patients with Alcohol Dependence

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of Alcohol Dependence, a condition where individuals have a strong craving for alcohol and find it difficult to control their drinking. The study will explore the impact of a treatment combining Cannabidiol (CBD) and Naltrexone on reducing the craving for alcohol. Cannabidiol is a compound found in cannabis plants, and Naltrexone is a medication commonly used to help people with alcohol dependence by reducing their desire to drink.

The purpose of the study is to assess how effective the combination of 800mg or 1200mg of oral CBD with 50mg of oral Naltrexone is in reducing alcohol cravings compared to a placebo. Participants will take part in a series of visits over a period of time, where they will receive either the active treatment or a placebo. The study will monitor changes in alcohol craving levels, quality of life, and other related symptoms throughout the trial.

Participants will be asked to attend several visits, where they will undergo assessments to measure their alcohol cravings and other health indicators. The study will also track changes in mood, anxiety, and overall well-being. This research aims to provide insights into how Cannabidiol and Naltrexone can work together to help individuals manage their alcohol dependence more effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of alcohol dependence, and understanding of the trial. Written consent is required.

    For women with childbearing potential and men with partners who can become pregnant, a highly effective birth control method must be used until one month after the last administration of the investigational medication. A negative pregnancy test is required at enrollment.

  2. Step 2

    Baseline visit

    The baseline visit occurs on day -2. During this visit, initial measurements of alcohol craving are taken using the Obsessive Compulsive Drinking Scale (OCDS-G).

    Additional assessments may include quality of life, depressive symptoms, and anxiety levels.

  3. Step 3

    Start of treatment

    On day 1, treatment begins. Participants receive either cannabidiol capsules or placebo capsules in addition to a standard treatment of 50mg oral naltrexone.

    The dosage of cannabidiol is either 800mg or 1200mg, taken orally. The specific dosage and whether it is cannabidiol or placebo is determined randomly.

  4. Step 4

    Follow-up visits

    Follow-up visits are scheduled on days 7, 14, 28, 42, 105, and 196. During these visits, alcohol craving and other health indicators are assessed.

    On day 14, the end of treatment is marked, and primary outcomes are measured. Secondary outcomes are assessed at subsequent visits.

  5. Step 5

    Optional assessments

    Participants may agree to additional assessments, such as using a study-specific app to track alcohol consumption and craving weekly.

    For some participants, additional tests like brain imaging may be conducted to study brain activity related to alcohol cues.

Who can join the trial?

7 criteria

  • Age between 18 and 70 years
  • Must have a diagnosis of alcohol dependence according to the ICD10, which is a system used to classify diseases
  • Must report alcohol craving as a symptom of alcohol dependence according to the ICD10 symptom definition
  • Must be able to understand the nature and consequences of the clinical trial
  • Must provide written informed consent before joining the study, which means you agree to participate after being informed about the trial
  • Must agree to be randomly assigned to different groups in the study
  • For women who can have children and men with partners who can have children, must use a highly effective birth control method until one month after the last study medication is given and have a negative pregnancy test at the time of joining the study

Who cannot join the trial?

3 criteria

  • People who are currently dependent on alcohol cannot participate. This means if you have a strong need to drink alcohol regularly and find it hard to stop, you may not be eligible.
  • Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Participants must not be part of a vulnerable population. This refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • Cannabidiol

    is a compound that comes from the cannabis plant. In this trial, it is being tested to see if it can help reduce the craving for alcohol in people who are dependent on it. Cannabidiol is thought to have calming effects and may help people feel less anxious or stressed, which could make it easier for them to resist the urge to drink alcohol.

  • Naltrexone

    is a medication that is commonly used to help people who are trying to stop drinking alcohol. It works by blocking the effects of alcohol in the brain, which can help reduce the desire to drink. In this trial, Naltrexone is used as a standard treatment to see if adding Cannabidiol can make it even more effective in reducing alcohol cravings.

What is already known about the treatment

  • Cannabidiol

    Cannabidiol, often referred to as CBD, is administered orally in this clinical trial, with doses of either 800mg or 1200mg. It is being studied for its potential to reduce alcohol cravings in individuals with alcohol dependence, when used alongside the medication Naltrexone. CBD is a compound found in cannabis plants, and it is gaining attention in medical literature for its possible therapeutic effects, although it is not yet widely established in standard medical practice for alcohol dependence. It is believed to work by interacting with the body's endocannabinoid system, which plays a role in regulating mood and cravings, but its exact mechanism of action is still being researched.

  • Naltrexone

    Naltrexone is taken orally, typically in a 50mg dose, and is already an established medication used to help manage alcohol dependence by reducing cravings. It works by blocking opioid receptors in the brain, which are involved in the reward system and can help decrease the desire to consume alcohol. Naltrexone is well-documented in medical literature and is classified as an opioid antagonist. In this trial, it is used as a background treatment to assess the additional effects of Cannabidiol on reducing alcohol cravings.

Investigated diseases

Alcohol dependence – Alcohol dependence is a chronic condition characterized by an individual's inability to control or stop alcohol consumption despite negative consequences. It involves a strong craving for alcohol, the development of tolerance, and withdrawal symptoms when alcohol use is reduced or stopped. Over time, individuals may need to consume increasing amounts of alcohol to achieve the same effects. The condition can lead to significant disruptions in personal, social, and occupational functioning. Alcohol dependence often progresses with repeated cycles of excessive drinking, withdrawal, and relapse. It can also be associated with various physical and mental health issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518164-12-00Protocol codeICONICplusEstimated enrolment150 patientsSponsorZentralinstitut Fuer Seelische Gesundheit

sourced from the EU Clinical Trials Register and site verification

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