Source Paper
Inverted U-Shaped Dose-Response Curve of the Anxiolytic Effect of Cannabidiol during Public Speaking in Real Life
Antonio W. Zuardi, Natália P. Rodrigues, Angélica L. Silva, Sandra A. Bernardo, Jaime E. C. Hallak et al.
Frontiers in Pharmacology • 2017
Spielberger State-Trait Anxiety Inventory
Objective: Assessment of trait anxiety propensity in healthy human subjects using the STAI trait version
Gather these items before starting the experiment. Check off items as you prepare.
Materials1
Spielberger et al.
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Protocol Steps
Subject Recruitment
Recruit healthy men and women aged 18-35 years with no history of past or current psychiatric illness, alcohol or other drug dependence through advertisement in the campus of the University of São Paulo in Ribeirão Preto
Note: Exclude participants with major medical conditions or taking medications with potential to interfere with study results
View evidence from paper
“Sixty healthy men and women aged 18–35 years, with no history of past or current psychiatric illness, alcohol or other drug dependence were recruited through advertisement in the campus of the University of São Paulo”
Eligibility Assessment and STAI-Trait Administration
Interview volunteers to assess eligibility and measure their propensity to anxiety through the trait version of the Spielberger State-Trait Anxiety Inventory (STAI)
Note: This assessment determines baseline anxiety trait levels
View evidence from paper
“The volunteers were interviewed in order to assess eligibility and to measure their propensity to anxiety through the trait version of the Spielberger State-Trait Anxiety Inventory”
Informed Consent
Obtain written informed consent from eligible participants who agreed to participate after being fully informed of the research procedures
Note: Procedures conformed to the Declaration of Helsinki and were approved by the Ethics Committee of the Ribeirão Preto Medical School University Hospital (HCRP - No. 12407/09)
View evidence from paper
“All volunteers gave written informed consent to participate after being fully informed of the research procedures, which conformed to the current terms of the Declaration of Helsinki”
Pre-Test Abstinence Instructions
Instruct eligible participants to abstain from drugs in the week prior to the tests and from alcohol and caffeine in the 24 hours before the test
Note: Critical for ensuring clean baseline measurements
View evidence from paper
“Eligible participants who agreed to participate were instructed to abstain from drugs in the week prior to the tests and from alcohol and caffeine in the 24 h before the test”
Group Allocation and Matching
Randomly allocate participants to five groups with 12 subjects each. Match groups according to gender, age, body mass index (BMI), and STAI-trait score
Note: Groups receive different doses of CBD (100, 300, and 900 mg), clonazepam (1 mg) or placebo in a double-blind, randomized design
View evidence from paper
“The volunteers were randomly allocated to five groups with 12 subjects each to receive different doses of CBD (100, 300, and 900 mg), clonazepam (1 mg) or placebo in a double-blind, randomized design. The groups were matched according to gender, age, body mass index (BMI), and STAI-trait score”