Ongoing Clinical Trials for Alcohol Abuse
Currently, there are 4 ongoing clinical trials investigating new treatments for alcohol abuse. These studies are exploring innovative approaches including psilocybin-assisted therapy and cannabidiol (CBD) treatments, conducted across Belgium, Germany, and Spain. The trials focus on helping patients reduce or stop alcohol consumption and manage cravings associated with severe alcohol dependence. (Also known as: Alcohol Use Disorder, Alcohol Dependence)
Clinical trial locations
- Belgium
- Germany
- Spain
Study on Psilocybin-Assisted Therapy for Patients with Severe Alcohol Use Disorder
This Belgian study explores an innovative approach combining psilocybin, a substance derived from certain mushrooms, with supportive therapy during a 28-day inpatient rehabilitation program.
Main inclusion criteria: Participants must be adults between 21 and 70 years old with a body mass index of at least 17.5 kg/m². They need a diagnosis of severe alcohol use disorder and must be enrolled in a 4-week detoxification program at Brugmann University Hospital. Candidates must be willing to abstain from alcohol during the program, which will be monitored with breathalyzer checks. They should understand French, be part of the Belgian social security system, and agree to have therapy sessions recorded. Women who can become pregnant must have negative pregnancy tests and use reliable birth control during the study and for four weeks after. Participants must be in good physical health and willing to avoid mind-altering substances throughout the study period.
Main exclusion criteria: The study is specifically designed for people with severe alcohol use disorder, so those without this diagnosis cannot participate. There are age restrictions, though both men and women are eligible. People considered part of vulnerable populations requiring special protection may be excluded.
Focus and goals: The trial compares a high dose of psilocybin (25 mg) with a lower dose (5 mg) acting as an active placebo. Both are given alongside supportive psychotherapy. The study measures changes in drinking habits from before the program begins until four weeks after hospital discharge. Researchers will also examine psychological aspects such as mood, anxiety, and the ability to cope with cravings. The goal is to understand how psilocybin, when combined with therapy, can support recovery.
Investigational drugs: The study uses PEX010 Psilocybin Capsules containing psilocybin, which interacts with serotonin receptors in the brain, particularly the 5-HT2A receptor. This interaction may alter mood and perception. The treatment is provided alongside supportive psychotherapy during the rehabilitation program.
Study on the Effects of Cannabidiol and Naltrexone on Alcohol Craving in Patients with Alcohol Dependence
This German study examines whether combining cannabidiol (CBD) with naltrexone can effectively reduce alcohol cravings in people dependent on alcohol.
Main inclusion criteria: Participants must be between 18 and 70 years old with a diagnosis of alcohol dependence according to international classification systems. They must report experiencing alcohol craving as a symptom. Candidates need to understand the trial’s nature and consequences and provide written informed consent. They must agree to be randomly assigned to different treatment groups. Women who can have children and men with partners who can become pregnant must use highly effective birth control until one month after the last medication dose. A negative pregnancy test is required at enrollment.
Main exclusion criteria: People currently dependent on alcohol cannot participate, meaning those with a strong ongoing need to drink regularly who find it difficult to stop are not eligible. The study has specific age range requirements. People considered part of vulnerable populations are excluded.
Focus and goals: The study tests whether 800mg or 1200mg of oral CBD combined with 50mg of oral naltrexone can reduce alcohol cravings compared to placebo. Participants attend multiple visits over time to assess craving levels, quality of life, mood, anxiety, and overall well-being. The research aims to provide insights into how these medications work together to help manage dependence more effectively.
Investigational drugs: CBD, a compound from cannabis plants with calming effects, is being tested to see if it can reduce anxiety and stress, making it easier to resist drinking urges. Naltrexone is an established medication that blocks opioid receptors in the brain involved in the reward system, reducing the desire to drink. The trial investigates whether adding CBD enhances naltrexone’s effectiveness.
Study of Cannabidiol compared to placebo to treat alcohol dependence in adults seeking treatment to achieve abstinence
This Spanish trial focuses on evaluating whether CBD can help people seeking to reduce or stop their alcohol consumption.
Main inclusion criteria: Participants must be between 18 and 65 years old with a diagnosis of moderate or severe alcohol use disorder according to medical diagnostic criteria. They need to understand and voluntarily agree to participate. Candidates must have had at least 8 heavy drinking days in the 30 days before screening (4 or more drinks per day for women, 5 or more for men). Those who can have children must agree to use approved birth control methods throughout the study. Participants must provide at least two contact persons and have a desire to reduce or stop drinking.
Main exclusion criteria: People under 18, pregnant or breastfeeding women, and those with severe liver disease cannot participate. The study excludes individuals currently using other medications for alcohol dependence, those with known CBD allergies, people with uncontrolled mental health conditions, and those with seizure history. Individuals with serious heart or unstable medical conditions, those unable to commit to regular visits, and people who have used illegal substances in the past 30 days are also excluded.
Focus and goals: Participants receive either CBD oral solution or placebo for 8 weeks, with a maximum daily dose of 600 mg CBD. The study evaluates how CBD affects drinking behavior and measures blood markers indicating alcohol use. Researchers assess medication tolerance, overall safety, and psychological aspects related to consumption. The trial also investigates how CBD interacts with the body’s endocannabinoid system.
Investigational drugs: CBD is a natural compound from cannabis plants that doesn’t cause a “high” feeling. It may help reduce alcohol cravings and support patients in maintaining abstinence by interacting with the endocannabinoid system, affecting neurotransmitter systems involved in addiction and reward pathways in the brain.
Study on Cannabidiol for Treating Alcohol Dependence in Patients Seeking Abstinence
Another Spanish study testing CBD’s potential to help individuals with alcohol dependence achieve abstinence.
Main inclusion criteria: Males and females aged 18 to 65 years with a DSM-5 diagnosis of moderate or severe alcohol use disorder can participate. The DSM-5 is a manual healthcare professionals use to diagnose mental disorders. Participants must provide voluntary informed consent, meaning they understand the study and agree to participate. Candidates must have experienced at least 8 heavy drinking days in the 30 days before screening (4 or more drinks for women, 5 or more for men). Those of childbearing potential must use approved contraception from screening throughout the trial. Participants must provide at least two locators (contact information for people who can help reach them) and express a desire to cut down or stop drinking.
Main exclusion criteria: Individuals not seeking treatment to stop drinking or unwilling to stop are excluded. People with other serious health conditions interfering with the study, pregnant or breastfeeding women, and current illegal drug users cannot participate. Those with uncontrolled severe mental health disorders, people unable to provide informed consent, and individuals participating in another clinical trial simultaneously are not eligible.
Focus and goals: The trial evaluates CBD’s potential to help reduce consumption and achieve abstinence. Participants receive either CBD or placebo as an oral solution. The study monitors changes in alcohol consumption using the Timeline Follow-back method and performs blood tests to measure markers indicating alcohol use. Researchers assess safety, tolerability, and psychological symptoms, while investigating CBD’s interaction with the endocannabinoid system.
Investigational drugs: CBD is a cannabis plant compound that doesn’t cause a “high.” Researchers explore whether CBD can support individuals in stopping drinking by interacting with the endocannabinoid system, potentially influencing neurotransmitter release and reducing cravings or withdrawal symptoms.
Summary
The four ongoing clinical trials for alcohol abuse represent innovative approaches to treating this challenging condition. A notable concentration of research is occurring in Spain, which hosts two CBD-focused trials, while Belgium and Germany each conduct one study. The trials show a clear research focus on cannabidiol (CBD), with three of the four studies investigating this compound, either alone or in combination with naltrexone. The Belgian trial stands out by exploring psilocybin-assisted therapy, representing a different therapeutic approach using psychedelic compounds combined with supportive psychotherapy.
These studies share common goals of reducing alcohol consumption, managing cravings, and supporting abstinence, but they employ different strategies. The trials generally target adults with moderate to severe alcohol use disorder who are motivated to reduce or stop drinking. Most studies require participants to have experienced multiple heavy drinking days in the month before enrollment and implement safety measures such as pregnancy tests and birth control requirements for those of childbearing potential.
The research reflects growing interest in cannabinoid-based treatments and psychedelic-assisted therapy as potential alternatives or complements to traditional approaches for managing alcohol dependence. These trials aim to provide evidence about safety, tolerability, and effectiveness of these novel interventions.
