- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05257044
Acute Effects of Cannabigerol
Acute Effects of Cannabigerol (CBG) on Mood and Cognition
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Washington
-
Pullman, Washington, United States, 99164
- Washington State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CBG
Participants will ingest 20 mg of CBG tincture in this arm
|
Participants will ingest CBG and placebo in a double-blind randomized cross-over design
|
|
Placebo Comparator: Placebo
Participants will ingest 20 mg of placebo tincture in this arm
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mood
Time Frame: Change from baseline to approx. 20 minutes after CBG/placebo use
|
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
Time Frame: Change from baseline to approx. 40 minutes after CBG/placebo use
|
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
Time Frame: Change from baseline to approx. 60 minutes after CBG/placebo use
|
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
Time Frame: Change from baseline to approx. 20 minutes after CBG/placebo use
|
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
Time Frame: Change from baseline to approx. 40 minutes after CBG/placebo use
|
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
Time Frame: Change from baseline to approx. 60 minutes after CBG/placebo use
|
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
Time Frame: Change from baseline to approx. 20 minutes after CBG/placebo use
|
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
Time Frame: Change from baseline to approx. 40 minutes after CBG/placebo use
|
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
Time Frame: Change from baseline to approx. 60 minutes after CBG/placebo use
|
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
Time Frame: Approx. 40 minutes after ingesting CBG/Placebo
|
Participants will complete the California Verbal Learning Test II (alternate forms)
|
Approx. 40 minutes after ingesting CBG/Placebo
|
|
Psychomotor
Time Frame: Change from baseline to approx. 45 minutes after ingesting CBG/Placebo
|
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)
Time Frame: Change from baseline to approx. 20 minutes after ingesting CBG/Placebo
|
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)
Time Frame: Change from baseline to approx. 40 minutes after ingesting CBG/Placebo
|
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)
Time Frame: Change from baseline to approx. 60 minutes after ingesting CBG/Placebo
|
Participants will provide ratings of each potential side effect using 0-10 scales
|
Change from baseline to approx. 60 minutes after ingesting CBG/Placebo
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carrie Cuttler, PhD, Washington State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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