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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol, Then Placebo | Experimental |
| |
| Placebo, Then Cannabidiol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Age 16 to 22. Does or does not drink alcohol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40500407 | Derived | 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. |
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All participants that were eligible and enrolled in the study (N= 36) completed randomized to a group.
Participants were recruited from September 2022 to April 2024, and data collection was completed in June 2024. Participants were recruited using a mix of approaches, including social media campaigns and in-person events. All participants completed a centralized intake process for youth substance use studies at the Medical University of South Carolina to determine eligibility before consenting for this specific study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cannabidiol, Then Placebo | In counterbalanced order, 19 youth (ages 17-22) were randomized to receive 600mg of cannabidiol before placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by an approximate 18-day washout period. |
| FG001 | Placebo, Then Cannabidiol | In counterbalanced order, 17 youth (ages 17-22) were randomized to receive 600mg of placebo before cannabidiol three hours before a neuroimaging and behavioral assessment paradigm, separated by an approximate 18-day washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Allocation |
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| First Wash-Out Period |
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| Second Allocation |
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| Second Wash-out Period |
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| Follow-Up |
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All participants who were eligible and enrolled completed randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cannabidiol, Then Placebo | In counterbalanced order, 19 youth (ages 17-22) were randomized to receive 600mg of cannabidiol before placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by an approximate 18-day washout period. |
| BG001 | Placebo, Then Cannabidiol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmol/kg | Changes 3 hours after administration of 600mg CBD vs. placebo |
|
At least 36 days (18-days for the first wash-out period and 18-days for the second wash-out period before follow-up)
Participants were asked about adverse events at every visit. Medication allocation visits (visit 1 and visit 2) adverse events were assessed by a medical clinician. At the follow-up visit (visit 3), they were assessed by study staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cannabidiol (600mg) | Adverse events assessed after the acute Cannabidiol (600mg) administration and washout period (~18 days). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lindsay Squeglia | Medical University of South Carolina | 843-792-5454 | squegli@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2023 | Jun 19, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2023 | Jul 2, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| 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. | 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. | Changes 2 hours after administration of 600mg CBD vs. placebo |
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In counterbalanced order, 17 youth (ages 17-22) were randomized to receive 600mg of placebo before cannabidiol three hours before a neuroimaging and behavioral assessment paradigm, separated by an approximate 18-day washout period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Outcomes when participants were given matched placebo |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mmol/kg | Changes 3 hours after administration of 600mg CBD vs. placebo |
|
|
|
|
| Primary | 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. | 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). | Posted | Mean | Standard Deviation | Z-score | Changes 3 hours after administration of 600mg CBD vs. placebo |
|
|
|
|
| Primary | 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. | Some participants did not have usable data based on data quality markers. | Posted | Mean | Standard Deviation | frequency ratio | Changes 2 hours after administration of 600mg CBD vs. placebo |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Changes 2 hours after administration of 600mg CBD vs. placebo |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 2 |
| 34 |
| EG001 | Placebo | Adverse events assessed after the acute placebo administration and washout period (~18 days). | 0 | 35 | 0 | 35 | 2 | 35 |
| Gastroenteritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Mouth | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
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| Nucleus Accumbens (R) |
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| Amygdala (L) |
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| Amygdala (R) |
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| Caudate (L) |
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| Caudate (R) |
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| Insula (L) |
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| Insula (R) |
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| Putamen (L) |
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| Putamen (R) |
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| Water Cue |
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| Baseline |
|