Acute Effects of Cannabigerol

Study Overview
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Brief Summary
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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.

Detailed Description
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Recruitment: Prospective participants aged 21+ who have experience using cannabis-based products will be recruited from our previous survey of CBG users, from a CBG distributor in Washington (WA) state, and via social media. These prospective participants will complete a brief online survey to determine they meet eligibility requirements. Specifically, to be eligible they will need to be 21+ years of age, reside in WA 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, and be free of serious psychiatric disorders, neurological and other serious medical conditions, pregnancy, or breastfeeding, or use of illicit substances in past 2 months. Pre-Study Preparation: Eligible participants will be contacted via email and will be asked to schedule a brief 10-minute Zoom meeting to discuss the study requirements and provide informed consent. During this brief Zoom call participants will be provided with the contact information of a CBG distributor in WA state so that they can obtain a small vial of CBG tincture (20 mg) and a small vial of placebo tincture that will be color-coded by the distributor and provided to participants at no cost. The researchers will not directly provide or handle the products. Rather, participants will obtain the product on their own without compensation. Participants will also be asked to download an app called DRUID the day prior to their testing session. This app is designed to assess cognitive and motor impairment. Finally, participants will be asked to abstain from using CBG or any cannabis products for at least 24 hours prior to participation in each testing session. Questions will also be solicited and answered at this time, informed consent will be provided online and then the two testing sessions will be scheduled. Testing Session 1: Participants will be randomly assigned to ingest either the CBG tincture (20 mg) or placebo tincture orally in the first testing session. Next, they will provide a series of baseline ratings of their mood, anxiety, and stress using 0 to 10 rating scales and the State Form of the State-Trait Anxiety Inventory. They will also provide baseline ratings of levels of intoxication and potential side effects (dry mouth, dry eyes, sleepiness, increased appetite, intoxication, heart palpitations/ racing heart) using 0 to 10 rating scales. Once all of these baseline measures have been obtained, the research assistant (RA) will ask if she can observe the participant ingesting one of the products using a double-blind procedure (vials will be color-coded and only the PI will know which color is used to code the two products). Next, participants will complete an online survey to obtain information on demographic characteristics, cannabis and CBG use patterns, depression, anxiety, and stress. This will also provide time for the CBG to take effect. After participants complete the approximately 20-minute survey they will be asked to obtain ratings of their mood, anxiety, and stress using 0 to 10 rating scales and the State Form of the State-Trait Anxiety Inventory. The investigators will also assess potential side effects (dry mouth, dry eyes, sleepiness, increased appetite, intoxication, heart palpitations/racing heart) and drug effects using 0 to 10 rating scales. Next, participants will complete the Trier Social Stress Test and then will complete ratings of their mood, anxiety, and stress using 0 to 10 rating scales and the State Form of the State-Trait Anxiety Inventory. Next, they will complete the California Verbal Learning Test II, and the cognitive and motor tests on the DRUID app. Finally, they will complete ratings of their mood, anxiety, and stress using 0 to 10 rating scales and the State Form of the State-Trait Anxiety Inventory. The investigators will also assess potential side effects (dry mouth, dry eyes, sleepiness, increased appetite, intoxication, heart palpitations/racing heart) using 0 to 10 rating scales. This entire process (completing testing session 1) will take approximately 90-minutes total. Testing Session 2: Approximately one-week later participants will complete the second testing session which will be identical to the first testing session with the exception of the product they will ingest. Specifically, those that ingested the CBG tincture in session 1 will ingest the placebo in session 2 and those that ingested the placebo in session 1 will ingest the CBG tincture in session 2. Also, at the end of the second testing session participants will be debriefed. Completing testing session 2 will also take approximately 90-minutes total. As such completing both sessions will require a total of 3 hours.

Official Title
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Acute Effects of Cannabigerol (CBG) on Mood and Cognition

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

Intervention / Treatment
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* Drug: Cannabigerol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 21+ 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 Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBG<br>Participants will ingest 20 mg of CBG tincture in this arm | Drug: Cannabigerol<br>* Participants will ingest CBG and placebo in a double-blind randomized cross-over design<br>|
| Placebo Comparator: Placebo<br>Participants will ingest 20 mg of placebo tincture in this arm | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory | Participants will complete the California Verbal Learning Test II (alternate forms) | Approx. 40 minutes after ingesting CBG/Placebo | 
| Psychomotor | Participants will complete the DRUID app | 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) | Participants will provide ratings of each potential side effect using 0-10 scales | 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) | Participants will provide ratings of each potential side effect using 0-10 scales | 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) | Participants will provide ratings of each potential side effect using 0-10 scales | Change from baseline to approx. 60 minutes after ingesting CBG/Placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Stress, Memory, Mood, Cognition, Side Effects