Trial of Cannabidiol for the treatment of alcohol dependence

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitario 12 De Octubre

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

Decision date (initial)

2024-12-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Foundation Hospital 12 de Octubre

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 3

1. Evaluate the effect of CBD on selfrepots of anxiety, depression, impulsivity, and alcohol craving.
2. Confirm tolerability and safety of CBD in these patients under the dose and pattern of administration.
3. 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.

Conditions and MedDRA coding

alcohol dependence

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Males and females aged 18-65
2. DSM-5 diagnosis of moderate or severe AUD.
3. Able to provide voluntary informed consent.
4. 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.
5. If of childbearing potential (male or female), are willing to use approved form of contraception from screening for duration of the trial.
6. Able to provide at least two locators.
7. Endorse desire to cut down or stop drinking.
8. Endorse desire to cut down or stop drinking.

Exclusion criteria 15

1. Current alcohol withdrawal (CIWA-Ar score >7).
2. Exclusionary medical conditions (e.g., current severe alcohol withdrawal requiring medical hospitalization, significantly impaired liver function).
3. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder.
4. 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).
5. 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.
6. History of severe Traumatic Brain Injury (LOC > 24 hours).
7. 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.
8. Significant laboratory abnormalities, including significantly impaired liver function, serious abnormalities of complete blood count or metabolic panel.
9. Active legal problems likely to result in incarceration within 12 weeks of treatment initiation.
10. Pregnancy or lactation.
11. 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.
12. Allergy to any ingredient of the study compound.
13. Current treatment for AUD, with exception of AA/12-step treatment/mutual-help groups-.
14. No inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays.
15. A positive urine drug screen for THC, cocaine and/or opioids at screen.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. To evaluate CBD efficacy on alcohol dependance
2. To evaluate psychological symptoms involved in alcohol consumptions
3. To evaluate endocannabinoid system
4. To evaluate CBD tolerability and safety in alcohol dependents

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario 12 De Octubre

Sponsor organisation

Hospital Universitario 12 De Octubre

Address

Bloque D, Avenida De Cordoba S/n Avenida De Cordoba S/n

City

Madrid

Postcode

28041

Country

Spain

Scientific contact point

Organisation

Hospital Universitario 12 De Octubre

Contact name

Gabriel Rubio Valladolid

Public contact point

Organisation

Hospital Universitario 12 De Octubre

Contact name

Gabriel Rubio Valladolid

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications