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
CBD and Clonazepam Dose-Response Study
Objective: Evaluate the effects of different doses of CBD (100, 300, 900 mg), clonazepam (1 mg), or placebo on anxiety and related behavioral measures in healthy human subjects using a double-blind, randomized design
Gather these items before starting the experiment. Check off items as you prepare.
Materials3
Software1
not specified • not mentioned
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Protocol Steps
Subject Recruitment and Screening
Sixty healthy men and women aged 18-35 years were recruited through advertisement at the University of São Paulo campus in Ribeirão Preto. Participants were screened for eligibility based on absence of psychiatric illness, alcohol or drug dependence, and major medical conditions.
Note: Participants taking medications with potential to interfere with study results were excluded
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”
Anxiety Assessment Interview
Eligible volunteers were interviewed to assess eligibility and measure their propensity to anxiety using the trait version of the Spielberger State-Trait Anxiety Inventory (STAI).
Note: STAI-trait score was used for group matching
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
Eligible participants who agreed to participate gave written informed consent after being fully informed of research procedures. Study conformed to Declaration of Helsinki and was approved by Ethics Committee of Ribeirão Preto Medical School University Hospital.
Note: Ethics approval number: 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
Volunteers were instructed to abstain from drugs in the week prior to tests and from alcohol and caffeine in the 24 hours before the test.
Note: Compliance with abstinence instructions was critical for study validity
View evidence from paper
“The volunteers 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”
Random Group Allocation
Eligible participants 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.
Note: Groups were matched according to gender, age, body mass index (BMI), and STAI-trait score
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”
Experimental Session
Subjects attended the experimental session to receive their assigned treatment (CBD dose, clonazepam, or placebo) and undergo behavioral testing.
Note: One volunteer from CBD-300 group could not attend and was withdrawn from the study
View evidence from paper
“One volunteer from the CBD-300 group could not attend the experimental session due to personal issues and was withdrawn from the study”