The purpose of this study is to evaluate the abuse potential of CBD to determine whether it should remain as a Schedule I drug under the Controlled Substances Act, or be recommended for decontrol.
This is a single-dose, randomized, double-blind, placebo- and active-controlled crossover study that evaluates CBD in comparison with THC, alprazolam, and placebo in healthy recreational drug users.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
42
Debra Kelsh, MD
Overland Park, Kansas, United States
Visual Analog Scale
Subjects will complete 13 scales. Each Visual Analog Scale is a self-administered assessment evaluating the subjective effects of a study agent. Subjects will be instructed to respond to the questions with regards to how they feel at that moment of the assessment on a 100 mm Likert Scale with 0 being "Not at all" and 100 being "Very" or "Extremely". All scales are unipolar or bipolar.
Time frame: 18 days
Incidence of Increased Vital Signs
Number of participants with adverse events as assessed by vital signs
Time frame: 25 days
Incidence of Increased ECG Reading
Number of participants with adverse events as assessed by ECG
Time frame: 25 days
Incidence of Clinically Significant Laboratory Values
Number of participants with adverse events as assessed by laboratory changes
Time frame: 25 days
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CBD capsule