What side effects are associated with this type of intervention?

Common treatments for alcoholism that are similar to Cannabidiol (CBD) in terms of modulating the endocannabinoid system or reducing alcohol cravings and anxiety include naltrexone, acamprosate, and gabapentin. Naltrexone can cause side effects such as nausea, headache, dizziness, and fatigue. Acamprosate may lead to diarrhea, anxiety, and insomnia. Gabapentin, used off-label, can cause dizziness, fatigue, and peripheral edema. While CBD is being studied for its potential benefits, it is generally well-tolerated but can cause side effects like dry mouth, diarrhea, and changes in appetite or weight.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcoholism, including naltrexone, acamprosate, and disulfiram. Naltrexone works by blocking opioid receptors, reducing the rewarding effects of alcohol. Acamprosate helps to stabilize chemical balance in the brain disrupted by alcohol dependence. Disulfiram causes unpleasant reactions when alcohol is consumed. While these medications do not directly modulate the endocannabinoid system like Cannabidiol (CBD), they aim to reduce alcohol cravings and consumption. Research on cannabinoid receptor antagonists like rimonabant has shown potential in preclinical studies, but clinical trials have been inconclusive and were halted due to psychiatric side effects.

What other types of research exist?

Promising alternatives to Cannabidiol (CBD) for treating alcoholism in 2024 include gabapentin, which may help reduce cravings and withdrawal symptoms, and aerobic exercise training, which has shown efficacy in reducing cravings and use. Additionally, established treatments like naltrexone and acamprosate remain viable options.

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Cannabinoid

CBD for Youth Alcoholism

Phase 2

Waitlist Available

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 16 to 22

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes 3 hours after administration of 600mg cbd vs. placebo

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing CBD, a compound from cannabis that doesn't cause a high, to help young people aged 16-22 who have alcohol addiction. The study will see if taking 600 mg of CBD can reduce cravings and anxiety related to alcohol use. Participants will be given either CBD or a non-active substance before undergoing brain scans and behavioral tests. Cannabidiol (CBD) has shown promise in decreasing alcohol consumption.

Who is the study for?

This trial is for young people aged 16-22, whether they drink alcohol or not. It's designed to see if CBD can help with youth alcohol use disorder. Participants will be involved in the study for about a month.

What is being tested?

The study tests the effects of cannabidiol (CBD) on youth with alcohol use issues using a double-blind method where neither researchers nor participants know who gets CBD or placebo during parts of the trial.

What are the potential side effects?

While not explicitly listed here, common side effects of CBD may include tiredness, diarrhea, changes in appetite/weight. However, each individual might experience different reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 16 and 22 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes 3 hours after administration of 600mg cbd vs. placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes 3 hours after administration of 600mg cbd vs. placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes 3 hours after administration of 600mg cbd vs. placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol cue reactivity (lab-based paradigm)

Alcohol cue reactivity neural activation

GABA

+1 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617

29%

Tiredness

20%

Constipation

18%

Drowsiness

11%

Poor sleep

11%

Dizziness

Poor Appetite

Headache

Nausea

Itching

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

CBD Oil Group

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, Then CannabidiolExperimental Treatment1 Intervention

Group II: Cannabidiol, Then PlaceboExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

FDA approved

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for alcoholism often target the brain's reward and stress systems to reduce cravings and withdrawal symptoms. Cannabidiol (CBD) modulates the endocannabinoid system, which may help reduce alcohol cravings and anxiety, making it a promising candidate for treating alcoholism. Other treatments include naltrexone, which blocks opioid receptors to reduce the rewarding effects of alcohol, and acamprosate, which stabilizes chemical signaling in the brain to alleviate withdrawal symptoms. Understanding these mechanisms is crucial for tailoring treatments to individual patients, potentially improving outcomes by addressing specific neurobiological pathways involved in addiction.

Changes in endocannabinoid contents in reward-related brain regions of alcohol-exposed rats, and their possible relevance to alcohol relapse.Cerebellar CB(1) receptor mediation of Delta(9)-THC-induced motor incoordination and its potentiation by ethanol and modulation by the cerebellar adenosinergic A(1) receptor in the mouse.