Phase II, Placebo-Controlled Study of Cannabidiol in the Management of Alcohol Dependence in Treatment-Seeking Patients
- Trial ID
- 2023-504439-42-00
- Protocol
- PLACONCANALDE
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this Phase II, placebo-controlled trial 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. This evaluation aims to assess the therapeutic potential of **cannabidiol (CBD)** in managing patients with alcohol dependence who are seeking treatment to achieve abstinence. The clinical relevance of this objective lies in its potential to provide a novel therapeutic option for individuals with alcohol dependence, a condition with significant health and social implications.
Secondary objectives include: - Evaluating the effect of CBD on self-reports of anxiety, depression, impulsivity, and alcohol craving. - Confirming the tolerability and safety of CBD in these patients under the specified dose and pattern of administration. - Determining modifications in gene expression in peripheral blood mononuclear cells (PBMCs) and endocannabinoids in plasma to identify biomarkers associated with the clinical changes induced by CBD.
Participants
The clinical trial focuses on evaluating the therapeutic potential of CBD in managing patients with **alcohol dependence** who are seeking treatment to achieve abstinence. The study population comprises both males and females aged 18 to 65 years, diagnosed with moderate or severe Alcohol Use Disorder (AUD) according to DSM-5 criteria. Participants must have experienced at least eight heavy drinking days in the 30 days prior to screening and express a desire to reduce or cease alcohol consumption. The trial includes individuals who are able to provide voluntary informed consent and at least two locators. Both genders are included, and participants of childbearing potential must agree to use an approved form of contraception throughout the trial. The sponsor has not provided information regarding the total number of participants. The trial population selection considers individuals' willingness to change their drinking habits, and the study involves a vulnerable population. Lifestyle factors such as diet and physical activity are not specified in the available data.
Plans and Procedures
The clinical trial is designed to evaluate the **efficacy** and safety of **cannabidiol** in the treatment of **alcohol dependence**. This is a Phase II, randomized, double-blind, placebo-controlled trial. The study will involve the administration of cannabidiol as an oral solution, with a maximum daily dose of 600 mg and a total dose not exceeding 33,600 mg over the course of the trial. The trial is expected to commence on January 1, 2025, and conclude by October 1, 2028, with an estimated duration of 8 weeks for each participant.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age (18-65 years), a DSM-5 diagnosis of moderate or severe alcohol use disorder, and a history of heavy drinking. Following successful screening, participants will be randomized to receive either cannabidiol or a placebo. The primary endpoints include evaluating the change in alcohol consumption using the Timeline Follow-back (TLFB) assessment and the change in percent Carbohydrate Deficient Transferrin (CDT) in serum. Secondary endpoints will assess psychological symptoms related to alcohol consumption and the endocannabinoid system.
Study visits will include regular follow-up assessments to monitor the participants' progress, adherence to the treatment regimen, and any adverse events. The end-of-study visit will involve a comprehensive evaluation of the participants' response to the treatment and overall health status. Participants may be withdrawn from the study if they experience significant adverse effects, fail to comply with the study protocol, or choose to withdraw consent. The trial aims to provide valuable insights into the potential therapeutic benefits of cannabidiol for individuals seeking to achieve abstinence from alcohol.
Treatment
The clinical trial involves the administration of **Cannabidiol**, an experimental medication formulated as an **oral solution**. The active substance in this formulation is **cannabinol**, which is chemically derived. The maximum daily dose of Cannabidiol is 600 mg, with a total maximum dose of 33,600 mg over the course of the treatment period, which spans up to 8 weeks. The route of administration is oral, and the medication is intended to be taken daily. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the prescribed regimen.
In addition to the experimental medication, a **placebo** is utilized as a comparator treatment in this study. The placebo is designed to mimic the Cannabidiol oral solution in appearance and administration route but does not contain the active substance. The use of a placebo allows for the assessment of the therapeutic potential of Cannabidiol by providing a control group for comparison. Participants receiving the placebo will follow the same dosing schedule as those receiving the active medication, and their compliance will similarly be monitored to maintain the integrity of the trial results.
Efficacy
Efficacy in this clinical trial will be assessed by evaluating the therapeutic potential of **cannabidiol (CBD)** in the management of patients with alcohol dependence. The primary endpoints include the change in the Timeline Follow-back (TLFB) assessment of alcohol consumption and the change in percent Carbohydrate Deficient Transferrin (CDT) in serum. These parameters will be used to determine the efficacy of CBD in reducing alcohol consumption and its impact on the endocannabinoid system, as well as to evaluate psychological symptoms associated with alcohol use. The trial will also assess the tolerability and safety of CBD in individuals with alcohol dependence. The efficacy assessments will be conducted using validated scales and laboratory tests, with data collection scheduled at specific timepoints throughout the trial duration. The trial is designed as a Phase II, placebo-controlled study, focusing on individuals diagnosed with moderate or severe alcohol use disorder (AUD) according to DSM-5 criteria, 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 Jan 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 |
|---|---|---|---|---|---|---|
Placebo to cannabidiol | Placebo | N/A | — | — | — | N/A |
Cannabidiol | Test | ORAL SOLUTION | ORAL USE | 600 | 8 | PRD11344601 |