Phase II, Placebo-controlled trial of Cannabidiol for the treatment of alcohol dependence (PLACONCANALDE)
- Trial ID
- 2023-504439-42-01
- Protocol
- PLACONCANALDE
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to determine the change in the Timeline Follow-back (TLFB) assessment of alcohol consumption and the change in percent Carbohydrate Deficient Transferrin (CDT) in serum, to evaluate the therapeutic potential of cannabidiol (CBD) in the management of patients with alcohol dependence who are seeking treatment to achieve abstinence. This objective addresses the clinical need to establish efficacy of CBD in reducing alcohol intake and normalizing biomarkers of chronic alcohol use in individuals with alcohol dependence.
The secondary objectives include:
• Evaluate the effect of CBD on self-reports of anxiety, depression, impulsivity, and alcohol craving.
• Confirm tolerability and safety of CBD in these patients under the dose and pattern of administration.
• Determine modifications in gene expression in peripheral blood mononuclear cells (PBMCs), and endocannabinoids in plasma to identify biomarkers associated to the clinical changes induced by CBD.
Participants
The sponsor did not provide information regarding the total number of participants enrolled in this clinical trial. The study population comprised both **males** and **females** aged **18 to 65 years**. Participants were individuals diagnosed with moderate or severe **alcohol use disorder** according to **DSM-5** criteria, specifically those who reported at least 8 **heavy drinking days** (defined as 4 or more drinks for women and 5 or more drinks for men) within the 30 days prior to screening. The trial population was selected based on participants' expressed desire to reduce or cease alcohol consumption and their ability to provide voluntary **informed consent**. Individuals of **childbearing potential**, both male and female, were required to use approved contraceptive methods throughout the trial duration. The trial involved a **vulnerable population**.
Plans and Procedures
This is a Phase II, placebo-controlled clinical trial evaluating **cannabidiol** for the treatment of **alcohol dependence**. The study employs a **randomized**, controlled design to assess the therapeutic potential of cannabidiol (CBD) in patients with alcohol dependence who are seeking treatment to achieve **abstinence**. The primary objective is to determine changes in alcohol consumption using the **Timeline Follow-back (TLFB)** assessment and changes in percent **Carbohydrate Deficient Transferrin (CDT)** in serum. The trial also aims to evaluate psychological symptoms involved in alcohol consumption, assess the **endocannabinoid system**, and determine the tolerability and safety of cannabidiol in this patient population.
The investigational medicinal product is cannabidiol oral solution containing **cannabinol** as the active substance, with a maximum daily dose of **600 mg** and a maximum total dose of **33600 mg** over the treatment period. The maximum treatment period is **8 weeks**. Participants will receive either the active cannabidiol oral solution or a matching **placebo**. The route of administration is **oral use**. The study is expected to commence recruitment in September 2025 and conclude in October 2028.
Eligible participants include males and females aged **18-65 years** who meet **DSM-5** diagnostic criteria for moderate or severe **alcohol use disorder (AUD)**. Participants must have at least 8 heavy drinking days (defined as 4 or more drinks for women, 5 or more drinks for men) in the 30 days prior to screening. Additional inclusion criteria require the ability to provide voluntary **informed consent**, endorsement of desire to reduce or stop drinking, ability to provide at least two locators, and willingness to use approved contraception methods from screening throughout the trial duration if of childbearing potential.
The study involves a series of scheduled visits throughout the trial period. The screening visit serves to assess eligibility criteria, obtain informed consent, and establish baseline measurements. Follow-up visits occur at regular intervals during the treatment phase to monitor efficacy outcomes, assess safety and tolerability, collect biological samples for **CDT** analysis, and evaluate adherence to the study protocol. The end-of-study visit includes final efficacy assessments, safety evaluations, and collection of endpoint data. Total participant involvement spans the duration of the treatment period plus follow-up assessments. Early termination from the study may occur due to participant withdrawal of consent, safety concerns, protocol violations, or at the discretion of the investigator if continuation is deemed not in the participant's best interest.
Treatment
The experimental treatment consists of **Cannabidiol** administered as an **oral solution**. The active substance is **cannabinol**, which is of chemical origin. The maximum daily dose is **600 mg**, administered via the **oral route**. The maximum total dose amount over the treatment period is **33600 mg**. The maximum treatment period is **8 weeks**. The product is classified under **ATC code N03AX24** and is manufactured by START FROM SCRATCH S.L. The formulation is not specifically designed for paediatric use.
A **placebo** matching cannabidiol is used as the comparator treatment in this trial. The placebo is designed to match the experimental treatment to maintain blinding throughout the study. Specific details regarding the pharmaceutical form, dosage, and route of administration for the placebo are not provided in the available data, though it is intended to be administered in a manner comparable to the active treatment to ensure appropriate study conduct and participant compliance monitoring.
Efficacy
Efficacy will be assessed through the evaluation of **alcohol dependence** using multiple parameters. The primary efficacy endpoints include the evaluation of **cannabidiol** efficacy on alcohol dependence, assessment of psychological symptoms involved in alcohol consumption, evaluation of the **endocannabinoid system**, and assessment of cannabidiol tolerability and safety in patients with alcohol dependence. The change in alcohol consumption will be measured using the **Timeline Follow-back (TLFB)** assessment. Additionally, the change in percent **Carbohydrate Deficient Transferrin (CDT)** in serum will be analyzed as a biomarker to evaluate the therapeutic potential of cannabidiol in the management of patients with alcohol dependence who are seeking treatment to achieve abstinence.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Males and females aged 18-65
- DSM-5 diagnosis of moderate or severe AUD.
- Able to provide voluntary informed consent.
- At least 8 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a man) in the 30 days prior to screen.
- If of childbearing potential (male or female), are willing to use approved form of contraception from screening for duration of the trial.
- Able to provide at least two locators.
- Endorse desire to cut down or stop drinking.
- Endorse desire to cut down or stop drinking.
Exclusion Criteria
- Current alcohol withdrawal (CIWA-Ar score >7).
- Exclusionary medical conditions (e.g., current severe alcohol withdrawal requiring medical hospitalization, significantly impaired liver function).
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder.
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
- Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant homicidally.
- History of severe Traumatic Brain Injury (LOC > 24 hours).
- DSM-5 diagnosis of current mild cannabis use disorder and/or moderate or severe substance use disorder for a substance other than alcohol or nicotine.
- Significant laboratory abnormalities, including significantly impaired liver function, serious abnormalities of complete blood count or metabolic panel.
- Active legal problems likely to result in incarceration within 12 weeks of treatment initiation.
- Pregnancy or lactation.
- Current use of exclusionary medications, including cannabinoids; treatments for addictions including alcohol; moderate to strong inhibitors of CYP3A4 or CYP2C19; medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7; and medications with a narrow therapeutic index which are substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, CYP2C19, CYP1A2, or CYP2B6.
- Allergy to any ingredient of the study compound.
- Current treatment for AUD, with exception of AA/12-step treatment/mutual-help groups-.
- No inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays.
- A positive urine drug screen for THC, cocaine and/or opioids at screen.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Not Yet Recruiting | 01 Sept 2025 | 118 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Cannabidiol | Test | ORAL SOLUTION | ORAL USE | 600 | 8 | PRD11344601 |
Placebo to cannabidiol | Placebo | N/A | — | — | — | N/A |