Acute Effects of Cannabigerol

NCT05257044 | Completed Phase 1

• 1 other identifier: 19162
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of hemp-derived cannabigerol (CBG) on anxiety, stress, mood, and cognition. Further, the severity of various side effects of CBG (sleepiness, dry mouth, dry eyes, increased appetite) will be assessed. As such, the study is focused on better understanding some of the potentially beneficial and detrimental effects of CBG on humans.

Conditions

Focus: To Examine Acute Effects of CBG on Anxiety, Stress, and Cognition

Keywords

Anxiety, Stress, Memory, Mood, Cognition, Side Effects

Outcome Measures

Primary Outcomes (9)

• Change in Mood

  Participants will provide ratings of their mood using 0-10 scales

  Change from baseline to approx. 20 minutes after CBG/placebo use

• Change in Mood

  Participants will provide ratings of their mood using 0-10 scales

  Change from baseline to approx. 40 minutes after CBG/placebo use

• Change in Mood

  Participants will provide ratings of their mood using 0-10 scales

  Change from baseline to approx. 60 minutes after CBG/placebo use

• Change in Stress

  Participants will provide ratings of their stress using 0-10 scales

  Change from baseline to approx. 20 minutes after CBG/placebo use

• Change in Stress

  Participants will provide ratings of their stress using 0-10 scales

  Change from baseline to approx. 40 minutes after CBG/placebo use

• Change in Stress

  Participants will provide ratings of their stress using 0-10 scales

  Change from baseline to approx. 60 minutes after CBG/placebo use

• Change in Anxiety

  Participants will provide ratings of their anxiety using 0-10 scales and will complete the State Form of the State-Trait Anxiety Inventory

  Change from baseline to approx. 20 minutes after CBG/placebo use

• Change in Anxiety

  Participants will provide ratings of their anxiety using 0-10 scales and will complete the State Form of the State-Trait Anxiety Inventory

  Change from baseline to approx. 40 minutes after CBG/placebo use

• Change in Anxiety

  Participants will provide ratings of their anxiety using 0-10 scales and will complete the State Form of the State-Trait Anxiety Inventory

  Change from baseline to approx. 60 minutes after CBG/placebo use

Secondary Outcomes (5)

• Memory

  Approx. 40 minutes after ingesting CBG/Placebo

• Psychomotor

  Change from baseline to approx. 45 minutes after ingesting CBG/Placebo

• Change in Potential Side Effects (dry mouth, dry eyes, sleepiness, increased appetite, intoxication, heart palpitations/racing heart)

  Change from baseline to approx. 20 minutes after ingesting CBG/Placebo

• Change in Potential Side Effects (dry mouth, dry eyes, sleepiness, increased appetite, intoxication, heart palpitations/racing heart)

  Change from baseline to approx. 40 minutes after ingesting CBG/Placebo

• Change in Potential Side Effects (dry mouth, dry eyes, sleepiness, increased appetite, intoxication, heart palpitations/racing heart)

  Change from baseline to approx. 60 minutes after ingesting CBG/Placebo

Study Arms (2)

CBG

EXPERIMENTAL

Participants will ingest 20 mg of CBG tincture in this arm

Drug: Cannabigerol

Placebo

PLACEBO COMPARATOR

Participants will ingest 20 mg of placebo tincture in this arm

Other: Placebo

Interventions

Cannabigerol DRUG

Participants will ingest CBG and placebo in a double-blind randomized cross-over design

CBG

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Self-identified man or woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• reside in Washington state
• own a smartphone
• have access to a private environment where they can access a computer with a webcam connected to a high-quality and stable internet
• speak fluent English
• be literate
• have experience using cannabis-based products without serious adverse reactions

You may not qualify if:

• serious psychiatric disorders (e.g., psychotic disorder, bipolar disorder)
• neurological and other serious medical conditions including head injury
• pregnancy, or breastfeeding
• use of illicit substances in past 2 months

Sponsors & Collaborators

• Washington State University: lead

Study Sites (1)

Washington State University

Pullman, Washington, 99164, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

cannabigerol

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Carrie Cuttler, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The vials of CBG and placebo will be color-coded and only the PI will know what the color codes mean. Participants and the research assistant will be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to ingest either CBG or a placebo in the first session. Those who ingest CBG in session 1 will ingest placebo in session 2. Those who ingest placebo in session 1 will ingest CBG in session 2.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: February 25, 2022
• Study Start: March 24, 2022
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Deidentified data will be retained indefinitely
• Access Criteria: Researchers wanting to conduct secondary data analysis following my own publication

Locations

US (1)