SYFa09cab21f19948e3b99545e73bf27e74

Not Yet RecruitingPhase 2

Trial of Cannabidiol for the treatment of alcohol dependence

Hospital Universitario 12 De Octubre Source

Hospital Universitario 12 De Octubre

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Brief Summary

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 CBD in the management of patients with alcohol dependence who are seeking treatment to achieve abstinence.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 10, 2026
Actual (reported)

Conditions

alcohol dependence

Outcome Measures

Primary Outcomes (4)

To evaluate CBD efficacy on alcohol dependance
To evaluate psychological symptoms involved in alcohol consumptions
To evaluate endocannabinoid system
To evaluate CBD tolerability and safety in alcohol dependents

Interventions

Placebo to cannabidiolType not reported

CannabidiolType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Age GroupsAdult (18-64)

You may qualify if:

Males and females aged 18-65
DSM-5 diagnosis of moderate or severe AUD.
Able to provide voluntary informed consent.

Sponsors & Collaborators

Hospital Universitario 12 De Octubre
Type not reportedlead

Study Sites (1)

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

Gabriel Rubio Valladolid+34917790887 gabriel.rubio@salud.madrid.org

Central Study Contacts

Gabriel Rubio Valladolid

+34917790887 gabriel.rubio@salud.madrid.org

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

March 10, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-504439-42-03
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:38:15 UTC

Documents

D1_protocol 2023-504439-42_V7 08092025

NCT00835718

A Study of MK0594 in Patients With Alcohol Dependence (0594-020)

Phase 2Terminated

NCT00437177

Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence (ALC-DRD2-APO)

Phase 2Unknown

NCT00804570

A Study for the Treatment of Alcohol Dependence

Phase 2Completed

NCT02251912

Oxytocin Treatment of Alcohol Dependence

Phase 2Completed

NCT00183144

A Therapeutic Workplace for Alcohol Dependence

Phase 2Completed

NCT06845124

A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence

Phase 2Recruiting

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.

You may not qualify if:

Current alcohol withdrawal (CIWA-Ar score >7).
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.
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.

Contact the study team to confirm eligibility.

D1_protocol 2023-504439-42-01_V8 12052026 tracked changes

D1_protocol summary 2023-504439-42_V7 08092025

D1_protocol summary 2023-504439-42-01_V8 12052026 tracked changes

Cannabidiol USDMF-AP-040825_0325

K1_recruitment arrangements for publication

L1_SIS and ICF V1 21112024 pregnancy

L1 SIS and ICF V5 20250623

Locations

ES(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations