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Cannabidiol in Youth Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cannabidiol

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

16 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Age 16 to 22. Does or does not drink alcohol.

Sites / Locations

Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cannabidiol, Then Placebo

Placebo, Then Cannabidiol

Arm Description

Outcomes

Primary Outcome Measures

Glutamate

Glutamate level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy

GABA

GABA level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy

Alcohol cue reactivity neural activation

Blood oxygen level dependent (BOLD) signal during alcohol cue reactivity in reward and salience brain regions

Alcohol cue reactivity (lab-based paradigm)

In vivo response to olfactory alcohol cues measured via heart rate

Alcohol cue reactivity (lab-based paradigm)

In vivo response to olfactory alcohol cues measured via salivation

Alcohol cue reactivity (lab-based paradigm)

In vivo response to olfactory alcohol cues measured via subjective ratings

Secondary Outcome Measures

Full Information

NCT ID

NCT05317546

First Posted

March 21, 2022

Last Updated

November 10, 2022

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT05317546

Brief Title

Cannabidiol in Youth Alcohol Use Disorder

Official Title

Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this study is to test cannabidiol (CBD) as a potentially effective candidate medication for youth alcohol use disorder (AUD). To accomplish this goal, this study will use a randomized, double-blind, within-subjects crossover design. In counterbalanced order, 35 youth (ages 16-22) will receive 600 mg of CBD or placebo three hours before a neuroimaging and behavioral assessment paradigm. The total amount of time the participant will be in the study is approximately one month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cannabidiol, Then Placebo

Arm Type

Experimental

Arm Title

Placebo, Then Cannabidiol

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cannabidiol

Other Intervention Name(s)

Placebo

Intervention Description

In counterbalanced order, 35 youth (ages 16-22) will receive 600mg of cannabidiol or placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by a 13-day washout period.

Primary Outcome Measure Information:

Title

Glutamate

Description

Glutamate level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy

Time Frame