Phase II Randomized Placebo‑Controlled Trial of Oral Cannabidiol (600 mg) for Reducing Alcohol Consumption in Adults with Alcohol Dependence

Primary objective: to assess the efficacy of cannabidiol in promoting abstinence in patients with alcohol dependence by quantifying (i) the change from baseline in the Timeline Follow-back interview‑derived alcohol consumption and (ii) the change in serum percent Carbohydrate Deficient Transferrin, both established markers of drinking behavior. These endpoints directly evaluate reduction in alcohol intake and biochemical verification of sobriety, supporting therapeutic potential. Secondary objectives:

• Evaluate the effect of the study drug on self‑reported anxiety, depression, impulsivity, and alcohol craving.
• Confirm tolerability and safety of the administered dose and regimen.
• Determine alterations in peripheral blood mononuclear cell gene expression and plasma endocannabinoid levels to identify biomarkers linked to clinical response.

The trial enrolled adult patients, both male and female, aged 18–65 years who met DSM‑5 criteria for moderate or severe alcohol use disorder and expressed a desire to reduce or cease drinking. Eligibility required at least eight heavy drinking days in the 30 days before screening, willingness to use approved contraception if of childbearing potential, ability to provide informed consent and two locators, and classification as a patient rather than a healthy volunteer. The population was considered vulnerable, and participants were selected based on the stated inclusion criteria; no additional lifestyle restrictions beyond the heavy‑drinking pattern were imposed. The sponsor did not provide information on the total number of participants enrolled.

The Phase II, placebo‑controlled study evaluates the therapeutic potential of oral cannabidiol (600 mg) versus matching placebo in adults with alcohol dependence. Eligible participants (aged 18–65, DSM‑5 moderate or severe AUD, ≥8 heavy‑drinking days in the prior 30 days, and willingness to use contraception if of child‑bearing potential) are screened, consented, and allocated to receive either cannabidiol oral solution or placebo for the duration of the trial. The protocol includes an initial screening visit to confirm eligibility, a baseline visit to initiate treatment, scheduled follow‑up visits for safety assessments, compliance checks, and collection of the Timeline Follow‑Back (TLFB) alcohol‑consumption diary and serum Carbohydrate‑Deficient Transferrin (CDT) measurements, and a final end‑of‑study visit for overall evaluation. Participant involvement spans the entire treatment period from baseline through the end‑of‑study assessment, with the overall trial timeline extending from May 2026 to October 2028. Participants may discontinue the study at any point, which would result in early termination of their involvement.

The investigational product is Cannabidiol supplied as an oral solution for oral use. Each dose contains 600 mg of cannabinol per administration. The formulation is provided in a single‑dose vial and is intended to be taken orally; the exact frequency of dosing is defined by the study protocol and administered under controlled conditions.

The comparator is a placebo formulated to match the appearance and volume of the cannabidiol oral solution. The placebo contains no active pharmaceutical ingredient and is administered by the same oral route as the active product.

Both study treatments are dispensed in labeled containers and administered according to a predetermined schedule. Dosing occurs at the study site under direct observation to ensure adherence. Compliance is monitored through documented administration records, count of returned containers, and participant diaries documenting intake times. Any deviation from the dosing schedule is recorded and reported per protocol requirements.

Efficacy assessment will focus on two quantitative parameters: the change from baseline in alcohol consumption measured by the Timeline Follow-back (TLFB) interview, and the change in serum percent Carbohydrate Deficient Transferrin (CDT) levels. TLFB is a structured, validated instrument administered by trained personnel to capture daily alcohol intake over a defined retrospective period. Serum CDT will be quantified using a standard laboratory assay that reflects recent heavy alcohol use.

Both TLFB data and CDT concentrations will be collected at baseline and at scheduled study visits throughout the trial. The collected values will be compared to baseline to determine the magnitude of change associated with cannabidiol treatment.