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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-08-14
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Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
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.
PlaceboSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (600mg) | 34 | 18.76 | 0.98 |
| Placebo | 35 | 18.57 | 1.15 |
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.
Eligibility
primary outcomes
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.
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.
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.
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.
Publications
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (600mg) | 34 | 4.25 | 0.26 |
| Placebo | 35 | 4.22 | 0.34 |
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.
Population: 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).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (600mg) | 33 | 1.02 | 1.58 |
| Placebo | 33 | 0.87 | 1.37 |
| Cannabidiol (600mg) | 33 | 0.62 | 0.85 |
| Placebo | 33 | 0.35 | 1.28 |
| Cannabidiol (600mg) | 33 | 0.53 | 0.91 |
| Placebo | 33 | 0.56 | 1.26 |
| Cannabidiol (600mg) | 33 | 0.66 | 1.23 |
| Placebo | 33 | 0.55 | 0.92 |
| Cannabidiol (600mg) | 33 | 0.68 | 1.10 |
| Placebo | 33 | 0.47 | 1.09 |
| Cannabidiol (600mg) | 33 | 0.29 | 1.00 |
| Placebo | 33 | 0.24 | 0.84 |
| Cannabidiol (600mg) | 33 | 0.51 | 1.00 |
| Placebo | 33 | 0.35 | 1.11 |
| Cannabidiol (600mg) | 33 | 0.10 | 1.37 |
| Placebo | 33 | 0.33 | 1.24 |
| Cannabidiol (600mg) | 33 | 0.12 | 1.23 |
| Placebo | 33 | 0.30 | 1.24 |
| Cannabidiol (600mg) | 33 | 0.40 | 1.16 |
| Placebo | 33 | 0.42 | 1.12 |
| Cannabidiol (600mg) | 33 | 0.42 | 1.14 |
| Placebo | 33 | 0.37 | 1.16 |
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.
Population: Some participants did not have usable data based on data quality markers.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (600mg) | 32 | 0.84 | 0.37 |
| Placebo | 32 | 0.81 | 0.41 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (600mg) | 34 | 23.18 | 11.73 |
| Placebo | 35 | 21.40 | 11.22 |
| Cannabidiol (600mg) | 34 | 18.56 | 9.65 |
| Placebo | 35 | 17.63 | 10.26 |
| Cannabidiol (600mg) | 34 | 16.47 | 7.64 |
| Placebo | 35 | 15.50 | 7.14 |
| Cannabidiol (600mg) | 34 | 16.18 | 7.30 |
| Placebo | 35 | 14.94 | 6.80 |
All participants that were eligible and enrolled in the study (N= 36) completed randomized to a group.
| Milestone | Cannabidiol, Then Placebo | Placebo, Then Cannabidiol |
|---|---|---|
| STARTED | 19 | 17 |
| COMPLETED | 19 | 17 |
| NOT COMPLETED | 0 | 0 |
| Milestone | Cannabidiol, Then Placebo | Placebo, Then Cannabidiol |
|---|---|---|
| STARTED | 19 | 17 |
| COMPLETED | 18 | 15 |
| NOT COMPLETED | 1 | 2 |
| Milestone | Cannabidiol, Then Placebo | Placebo, Then Cannabidiol |
|---|---|---|
| STARTED | 18 | 15 |
| COMPLETED | 18 | 15 |
| NOT COMPLETED | 0 | 0 |
| Milestone | Cannabidiol, Then Placebo | Placebo, Then Cannabidiol |
|---|---|---|
| STARTED | 18 | 15 |
| COMPLETED | 18 | 14 |
| NOT COMPLETED | 0 | 1 |
| Milestone | Cannabidiol, Then Placebo | Placebo, Then Cannabidiol |
|---|---|---|
| STARTED | 18 | 14 |
| COMPLETED | 18 | 14 |
| NOT COMPLETED | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Conjunctivitis | Eye disorders | Cannabidiol (600mg): 1 / 34 · Placebo: 0 / 35 |
| Gastroenteritis | Gastrointestinal disorders | Cannabidiol (600mg): 0 / 34 · Placebo: 1 / 35 |
| Dry Mouth | General disorders | Cannabidiol (600mg): 1 / 34 · Placebo: 0 / 35 |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Cannabidiol (600mg): 0 / 34 · Placebo: 1 / 35 |
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.