Cannabidiol in Youth Alcohol Use Disorder

Study Overview
=================
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, 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.

Official Title
-----------------
Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Drug: Cannabidiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Age 16 to 22. Does or does not drink alcohol.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol, Then Placebo<br> | Drug: Cannabidiol<br>* 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.<br>* Other names: Placebo;|
| Experimental: Placebo, Then Cannabidiol<br> | Drug: Cannabidiol<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glutamate | Glutamate level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy | Changes 3 hours after administration of 600mg CBD vs. placebo | 
| GABA | GABA level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy | Changes 3 hours after administration of 600mg CBD vs. placebo | 
| Alcohol cue reactivity neural activation | Blood oxygen level dependent (BOLD) signal during alcohol cue reactivity in reward and salience brain regions | Changes 3 hours after administration of 600mg CBD vs. placebo | 
| Alcohol cue reactivity (lab-based paradigm) | In vivo response to olfactory alcohol cues measured via heart rate | Changes 3 hours after administration of 600mg CBD vs. placebo | 
| Alcohol cue reactivity (lab-based paradigm) | In vivo response to olfactory alcohol cues measured via salivation | Changes 3 hours after administration of 600mg CBD vs. placebo | 
| Alcohol cue reactivity (lab-based paradigm) | In vivo response to olfactory alcohol cues measured via subjective ratings | Changes 3 hours after administration of 600mg CBD vs. placebo |