Alcohol Use DisorderPhase 2NCT05317546

Cannabidiol in Youth Alcohol Use Disorder

A Phase 2 study testing Cannabidiol in people with Alcohol Use Disorder, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 22 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Use Disorder
What is being tested?: Cannabidiol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2022to 25 Jun 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 22 years
All sexes
Healthy volunteers accepted
Child, Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder

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, 50 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.

Conditions: Alcohol Use Disorder
Being tested: Cannabidiol
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CannabidiolDrug
Also called Placebo
In counterbalanced order, 50 youth (ages 16-22) will receive 600mg of cannabidiol or placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by an approximate 18-day washout period.

Study groups in NCT05317546
Study group	Role	What they receive
Cannabidiol, Then Placebo	Experimental	Not described Receives: Drug: Cannabidiol
Placebo, Then Cannabidiol	Experimental	Not described Receives: Drug: Cannabidiol

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentrations of Glx (i.e., Glutamate + Glutamine)
Using magnetic resonance spectroscopy and a within-subjects design, we measured Concentrations of Glx (i.e., glutamate + glutamine) levels in the anterior cingulate cortex in adolescents during cannabidiol (600mg) or placebo administration. Values provided are absolute values (mmol/kg) measured 3 hours after medication administration. Due to complexities of this method, "normal" levels of Glx are not known; thus, we cannot make conclusions about the meaning of "higher" or "lower" glutamate levels when comparing cannabidiol to placebo.
Measured: Changes 3 hours after administration of 600mg CBD vs. placebo
GABA+
Using magnetic resonance spectroscopy and a within-subjects design, we measured GABA+ (GABA plus macromolecules) levels in the anterior cingulate cortex in adolescents during cannabidiol (600mg) or placebo administration. Values provided are absolute values (mmol/kg) measured 3 hours after medication administration. Due to complexities of this method, "normal" levels of GABA are not known; thus, we cannot make conclusions about the meaning of "higher" or "lower" GABA levels when comparing cannabidiol to placebo.
Measured: Changes 3 hours after administration of 600mg CBD vs. placebo
Alcohol Cue Reactivity Neural Activation
Assessing the change in neural reactivity to alcohol cues after each round of medication: Cannabidiol vs. placebo. Cue reactivity is a type of learned response which is observed in individuals who use substances (e.g., alcohol) and involves significant physiological reactions to presentations of substance-related stimuli (i.e., alcohol images) in comparison to neutral images (e.g., non-alcoholic beverages ) measured by BOLD (Blood Oxygen Level-Dependent response). ROIs were (left and right hemisphere): amygdala, caudate, insula, nucleus accumbens, and putamen. The mean Z-statistic within each ROI mask is reported. A Z-score of 0 represents the population mean (e.g., no activation), where higher absolute Z-scores indicate greater evidence of activation (positive or negative) in the ROI compared to baseline. Z-scores do not have inherent clinical thresholds. Higher Z-scores generally reflect stronger task-related BOLD signal changes.
Measured: Changes 3 hours after administration of 600mg CBD vs. placebo
Heart Rate Variability
All participants underwent an in vivo, olfactory alcohol cue exposure procedure. Participants smelled water followed by the participant's preferred beverage containing alcohol and apple juice in a counterbalanced order for three minutes each, with a three-minute rest period in between each liquid. The contents were poured into a cup in the participant's presence. During the task, electrocardiogram data were collected and used to create the heart rate variability (HRV) outcome related to the Sympathetic: Vagal ratio, which is the ratio of low-frequency to high-frequency power, derived from spectral HRV analysis. Higher values suggest increased sympathetic activity or reduced vagal activity.
Measured: Changes 2 hours after administration of 600mg CBD vs. placebo
PhenX Toolkit Alcohol Urges Questionnaire
All participants underwent an in vivo, olfactory alcohol cue exposure procedure. Participants smelled water followed by the participant's preferred beverage containing alcohol and apple juice in a counterbalanced order for three minutes each, with a three-minute rest period in between each liquid. The contents were poured into a cup in the participant's presence. After each beverage exposure, self-reported alcohol craving was collected via the PhenX Toolkit Alcohol Urges Questionnaire (AUQ). The AUQ consists of eight statements about the participant's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The participant was asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree" with a scare range of 8 to 56 where higher scores represent higher alcohol craving.
Measured: Changes 2 hours after administration of 600mg CBD vs. placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202225 Jun 2024

First posted8 Apr 2022
Study start1 Oct 2022
Primary completion25 Jun 2024
Study completion25 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05317546
Sponsor's protocol ID: Pro00119770
Status last verified: Jul 2025
First submitted: 21 Mar 2022
Last updated: 14 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kirkland AE, Browning BD, Meredith LR, Robertson E, Herring C, Tomko RL, Gray KM, Squeglia LM. The neural and psychophysiological effects of cannabidiol in youth with alcohol use disorder: A randomized controlled clinical trial. Neuropsychopharmacology. 2025 Sep;50(10):1482-1492. doi: 10.1038/s41386-025-02141-z. Epub 2025 Jun 11.
PubMed 40500407

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder
ClinicalTrials.gov ID: NCT05317546
Acronym / sponsor ID: Pro00119770
Conditions: Alcohol Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 1 Oct 2022 (actual)
Primary completion: 25 Jun 2024 (actual)
Study completion: 25 Jun 2024 (actual)
First posted: 8 Apr 2022 (actual)
Results: Posted 14 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cannabidiol, Then Placebo	Experimental	Drug: Cannabidiol
Placebo, Then Cannabidiol	Experimental	Drug: Cannabidiol

Who may qualify

Ages: 16 to 22 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CannabidiolAlso: PlaceboIn counterbalanced order, 50 youth (ages 16-22) will receive 600mg of cannabidiol or placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by an approximate 18-day washout period.	Drug	Cannabidiol, Then Placebo, Placebo, Then Cannabidiol

Primary outcome

Concentrations of Glx (i.e., Glutamate + Glutamine)
Time frame: Changes 3 hours after administration of 600mg CBD vs. placebo
Using magnetic resonance spectroscopy and a within-subjects design, we measured Concentrations of Glx (i.e., glutamate + glutamine) levels in the anterior cingulate cortex in adolescents during cannabidiol (600mg) or placebo administration. Values provided are absolute values (mmol/kg) measured 3 hours after medication administration. Due to complexities of this method, "normal" levels of Glx are not known; thus, we cannot make conclusions about the meaning of "higher" or "lower" glutamate levels when comparing cannabidiol to placebo.
GABA+
Time frame: Changes 3 hours after administration of 600mg CBD vs. placebo
Using magnetic resonance spectroscopy and a within-subjects design, we measured GABA+ (GABA plus macromolecules) levels in the anterior cingulate cortex in adolescents during cannabidiol (600mg) or placebo administration. Values provided are absolute values (mmol/kg) measured 3 hours after medication administration. Due to complexities of this method, "normal" levels of GABA are not known; thus, we cannot make conclusions about the meaning of "higher" or "lower" GABA levels when comparing cannabidiol to placebo.
Alcohol Cue Reactivity Neural Activation
Time frame: Changes 3 hours after administration of 600mg CBD vs. placebo
Assessing the change in neural reactivity to alcohol cues after each round of medication: Cannabidiol vs. placebo. Cue reactivity is a type of learned response which is observed in individuals who use substances (e.g., alcohol) and involves significant physiological reactions to presentations of substance-related stimuli (i.e., alcohol images) in comparison to neutral images (e.g., non-alcoholic beverages ) measured by BOLD (Blood Oxygen Level-Dependent response). ROIs were (left and right hemisphere): amygdala, caudate, insula, nucleus accumbens, and putamen. The mean Z-statistic within each ROI mask is reported. A Z-score of 0 represents the population mean (e.g., no activation), where higher absolute Z-scores indicate greater evidence of activation (positive or negative) in the ROI compared to baseline. Z-scores do not have inherent clinical thresholds. Higher Z-scores generally reflect stronger task-related BOLD signal changes.
Heart Rate Variability
Time frame: Changes 2 hours after administration of 600mg CBD vs. placebo
All participants underwent an in vivo, olfactory alcohol cue exposure procedure. Participants smelled water followed by the participant's preferred beverage containing alcohol and apple juice in a counterbalanced order for three minutes each, with a three-minute rest period in between each liquid. The contents were poured into a cup in the participant's presence. During the task, electrocardiogram data were collected and used to create the heart rate variability (HRV) outcome related to the Sympathetic: Vagal ratio, which is the ratio of low-frequency to high-frequency power, derived from spectral HRV analysis. Higher values suggest increased sympathetic activity or reduced vagal activity.
PhenX Toolkit Alcohol Urges Questionnaire
Time frame: Changes 2 hours after administration of 600mg CBD vs. placebo
All participants underwent an in vivo, olfactory alcohol cue exposure procedure. Participants smelled water followed by the participant's preferred beverage containing alcohol and apple juice in a counterbalanced order for three minutes each, with a three-minute rest period in between each liquid. The contents were poured into a cup in the participant's presence. After each beverage exposure, self-reported alcohol craving was collected via the PhenX Toolkit Alcohol Urges Questionnaire (AUQ). The AUQ consists of eight statements about the participant's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The participant was asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree" with a scare range of 8 to 56 where higher scores represent higher alcohol craving.

Results and safety

Results posted to the registry on 14 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cannabidiol, Then Placebo	19	19
Placebo, Then Cannabidiol	17	17

Primary outcome: Concentrations of Glx (i.e., Glutamate + Glutamine)

Time frame: Changes 3 hours after administration of 600mg CBD vs. placebo. Mean (Standard Deviation). Unit: mmol/kg

Measure	Cannabidiol (600mg) n = 34	Placebo n = 35
Value	18.76 (0.98)	18.57 (1.15)

Cannabidiol (600mg) vs Placebo: p = 0.33, Mixed Models Analysis

Primary outcome: GABA+

Time frame: Changes 3 hours after administration of 600mg CBD vs. placebo. Mean (Standard Deviation). Unit: mmol/kg

Measure	Cannabidiol (600mg) n = 34	Placebo n = 35
Value	4.25 (0.26)	4.22 (0.34)

Cannabidiol (600mg) vs Placebo: p = 0.75, Mixed Models Analysis

Primary outcome: Alcohol Cue Reactivity Neural Activation

Time frame: Changes 3 hours after administration of 600mg CBD vs. placebo. Mean (Standard Deviation). Unit: Z-score

Measure	Cannabidiol (600mg) n = 33	Placebo n = 33
Anterior Cingulate Cortex	1.02 (1.58)	0.87 (1.37)
Nucleus Accumbens (L)	0.62 (0.85)	0.35 (1.28)
Nucleus Accumbens (R)	0.53 (0.91)	0.56 (1.26)
Amygdala (L)	0.66 (1.23)	0.55 (0.92)
Amygdala (R)	0.68 (1.10)	0.47 (1.09)
Caudate (L)	0.29 (1.00)	0.24 (0.84)
Caudate (R)	0.51 (1.00)	0.35 (1.11)
Insula (L)	0.10 (1.37)	0.33 (1.24)

Cannabidiol (600mg) vs Placebo: p >0.05, Mixed Models Analysis

Population analysed: 33 participants had complete, usable data (n=3 dropped out before visit 2; n=1 without MRI data at visit 2; n= 1 with head motion at visit 1).

Primary outcome: Heart Rate Variability

Time frame: Changes 2 hours after administration of 600mg CBD vs. placebo. Mean (Standard Deviation). Unit: frequency ratio

Measure	Cannabidiol (600mg) n = 32	Placebo n = 32
Value	0.84 (0.37)	0.81 (0.41)

Cannabidiol (600mg) vs Placebo: p = 0.82, Mixed Models Analysis

Population analysed: Some participants did not have usable data based on data quality markers.

Adverse events

Time frame: At least 36 days (18-days for the first wash-out period and 18-days for the second wash-out period before follow-up). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cannabidiol (600mg)	0 of 34 (0%)	2 of 34 (5.9%)	0 of 34
Placebo	0 of 35 (0%)	2 of 35 (5.7%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40500407Kirkland AE, Browning BD, Meredith LR, Robertson E, Herring C, Tomko RL, Gray KM, Squeglia LM. The neural and psychophysiological effects of cannabidiol in youth with alcohol use disorder: A randomized controlled clinical trial. Neuropsychopharmacology. 2025 Sep;50(10):1482-1492. doi: 10.1038/s41386-025-02141-z. Epub 2025 Jun 11.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabidiol in people with Alcohol Use Disorder, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentrations of Glx (i.e., Glutamate + Glutamine) (time frame: Changes 3 hours after administration of 600mg CBD vs. placebo). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05317546, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.