Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638996
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
Acute Psychological and Physiological Effects of Cannabigerol
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Psychological and Physiological Effects of Cannabigerol CBG
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBG
Brief Summary:
The purpose of this study is to examine the acute effects of cannabigerol CBG on various psychological eg anxiety stress mood memory impairment intoxication side effects and physiological blood pressure cortisol heart rate variability electrodermal activity pain tolerance temperature outcomes Further potential side effects of CBG sleepinessfatigue dry moutheyes increased appetite and dizziness nausea 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:
Recruitment Healthy adult participants aged 21 will be recruited from the community Pullman Moscow Palouse Colfax Colton Spokane Lewiston Clarkson via advertisements posted on campus in businesses including cannabis dispensaries and on social media Prospective participants will complete a brief online Qualtrics survey to determine eligibility Specifically to be eligible participants will need to be 21 years of age speak fluent English be literate be free of serious psychiatric disorders psychotic disorders bipolar disorders neurological disorders head injuries brain tumors Parkinsons disease diabetes low blood pressure pregnancy or breastfeeding Participants must not report recent use past 2 months of illicit substances or dietary restrictions that would prevent them from eating the standardized breakfast muffin yogurt juicemilk
Eligible participants will be contacted via email and will be asked to schedule two testing sessions 1 week apart that will begin between 830 and 930 am They will be asked to abstain from CBG use for 1 week before the first testing session and to fast and abstain from cannabis use from midnight the night before each session 85 - 95 hours The PI will use a random number generator to randomly assign each participant to ingest either the CBG tincture 50 mg or placebo tincture orally in the first testing session and the opposite tincture in the second testing session
Consent and Eligibility Confirmation Participants will meet a graduate research assistant in The Health Cognition THC lab in the Department of Psychology at Washington State University After obtaining written informed consent participants will be asked when they last used CBG if applicable when they last used cannabis if applicable and when they last ate Participants who report using CBG within the past week or cannabis after midnight the night prior or eating that day will be rescheduled and will be reminded that they must abstain from CBG for one week as well as from any cannabis use and food consumption on the day of the testing session Participants who adhered to the abstinence requirements will be asked to complete a 12-panel urine drug test to ensure they test negative for illicit drugs Participants who test positive for illicit drugs other than THC are not eligible and will not be permitted to complete the study Participants who pass the drug test will have their blood pressure measured Those with blood pressure lower than 9060 mm Hg indicating hypotension will be excused
T0 Baseline Assessments Participants will be asked to wear a medical-grade wristband Embrace device that will continuously monitor their heart rate electrodermal activity and temperature They will also wear a CALERA body temperature logger as a secondary measure of temperature They will also be asked to provide a small saliva sample by rinsing their mouth for 1 minute chewing on a Salivette for 1 minute and then spitting the saturated Salivette in a sterile tube Next they will then complete a baseline assessment of motorcognitive impairment using the DRiving Under the Influence of Drugs DRUID app
Next they will provide baseline ratings of their anxiety stress and mood using 0 to 10 visual analog rating scales and the Positive and Negative Affective Schedule PANAS Participants will also provide baseline ratings of potential side effects dry mouth dry eyes sleepiness increased appetite nausea heart palpitationsracing heart dizziness using 0 not at all severe to 10 extremely severe visual analog scales They will also be asked if they are experiencing any other physiological or psychological symptoms in an open-ended manner and to rate each on 0 not at all to 10 severe rating scales
CBGPlacebo Administration Once the baseline measures have been obtained participants will be fed a high-fat 30g fat breakfast Costco muffin yogurt milkjuice to standardize food intake and increase the bioavailabilitypotency of the CBG The research assistant will then give the participant the product 50 mg CBG or placebo diluted in a small opaque cup of water to orally ingest in a double-blind manner the PI will put the product in the testing room before each session Next participants will complete an online Qualtrics survey to measure demographic characteristics depression anxiety and stress They will then watch a nature video until it has been a total of 40 min since orally ingesting the product to give it time to take effect
T1 Assessments Forty min after product administration participants will have their blood pressure measured provide another saliva sample and complete the DRUID impairment app They will re-rate their anxiety stress and mood using 0 to 10 visual analog rating scales and the PANAS They will also rate the drug effects intoxication drug effects drug liking and they will re-rate the potential side effects dry mouth dry eyes sleepiness increased appetite nausea heart palpitationsracing heart dizziness To capture other potential side effects they will be asked if they are experiencing any other physiological or psychological symptoms in an open-ended manner and to rate the severity of each on 0 not at all to 10 severe rating scales
T2 Assessments Next participants will engage in a modified version of the Maastricht Acute Stress Test MAST to determine whether CBG modifies responses to stress Specifically participants will complete three cold pressor trials in which they will be instructed to hold their hand in cold water 0 degrees for 3 minutes They will be informed they can remove their hand if it becomes too painful and the duration of time that they keep their hand in the cold pressor on each trial will be used as an objective measure of pain tolerance After each trial participants will subjectively rate the severity of pain they experienced using 0 to 10 visual analog rating scales Between the three cold pressor trials participants will be instructed to count backward from 2043 by 17s as quickly and as accurately as possible When they make an error they will receive negative feedback and will be instructed to start the mental arithmetic over again
After the MAST participants will provide a third blood pressure assessment and saliva sample and will complete another trial of the DRUID app They will re-rate their anxiety stress and mood using 0 to 10 visual analog rating scales and the PANAS They will also re-rate subjective drug effects and side effects using 0 to 10 visual analog rating scales and an open-ended question
T3 Assessments Next participants will complete a short battery of memory tests Specifically they will complete the California Verbal Learning Test the Deese-Roediger-McDermott paradigm the Digit Span Forwards Test and the Digit Span Backwards Test
After the memory tests participants will be asked to provide a fourth blood pressure assessment and saliva sample and will complete the DRUID app They will re-rate their mood anxiety and stress and will complete the PANAS They will re-rate subjective drug effects and potential side effects including answering an open-ended question about perceived side effects with follow-up severity ratings
Finally participants will complete a brief survey to assess their cannabis and CBG use patterns
Testing Session 2 After a one-week washout period participants will complete the second testing session which will be identical to the first session except for the product they will ingest Specifically those that ingested the 50 mg CBG tincture in Session 1 will ingest the 50 mg placebo tincture in Session 2 and those that ingested the placebo in Session 1 will ingest the CBG tincture in Session 2
Eligible participants will be contacted via email and will be asked to schedule two testing sessions 1 week apart that will begin between 830 and 930 am They will be asked to abstain from CBG use for 1 week before the first testing session and to fast and abstain from cannabis use from midnight the night before each session 85 - 95 hours The PI will use a random number generator to randomly assign each participant to ingest either the CBG tincture 50 mg or placebo tincture orally in the first testing session and the opposite tincture in the second testing session
Consent and Eligibility Confirmation Participants will meet a graduate research assistant in The Health Cognition THC lab in the Department of Psychology at Washington State University After obtaining written informed consent participants will be asked when they last used CBG if applicable when they last used cannabis if applicable and when they last ate Participants who report using CBG within the past week or cannabis after midnight the night prior or eating that day will be rescheduled and will be reminded that they must abstain from CBG for one week as well as from any cannabis use and food consumption on the day of the testing session Participants who adhered to the abstinence requirements will be asked to complete a 12-panel urine drug test to ensure they test negative for illicit drugs Participants who test positive for illicit drugs other than THC are not eligible and will not be permitted to complete the study Participants who pass the drug test will have their blood pressure measured Those with blood pressure lower than 9060 mm Hg indicating hypotension will be excused
T0 Baseline Assessments Participants will be asked to wear a medical-grade wristband Embrace device that will continuously monitor their heart rate electrodermal activity and temperature They will also wear a CALERA body temperature logger as a secondary measure of temperature They will also be asked to provide a small saliva sample by rinsing their mouth for 1 minute chewing on a Salivette for 1 minute and then spitting the saturated Salivette in a sterile tube Next they will then complete a baseline assessment of motorcognitive impairment using the DRiving Under the Influence of Drugs DRUID app
Next they will provide baseline ratings of their anxiety stress and mood using 0 to 10 visual analog rating scales and the Positive and Negative Affective Schedule PANAS Participants will also provide baseline ratings of potential side effects dry mouth dry eyes sleepiness increased appetite nausea heart palpitationsracing heart dizziness using 0 not at all severe to 10 extremely severe visual analog scales They will also be asked if they are experiencing any other physiological or psychological symptoms in an open-ended manner and to rate each on 0 not at all to 10 severe rating scales
CBGPlacebo Administration Once the baseline measures have been obtained participants will be fed a high-fat 30g fat breakfast Costco muffin yogurt milkjuice to standardize food intake and increase the bioavailabilitypotency of the CBG The research assistant will then give the participant the product 50 mg CBG or placebo diluted in a small opaque cup of water to orally ingest in a double-blind manner the PI will put the product in the testing room before each session Next participants will complete an online Qualtrics survey to measure demographic characteristics depression anxiety and stress They will then watch a nature video until it has been a total of 40 min since orally ingesting the product to give it time to take effect
T1 Assessments Forty min after product administration participants will have their blood pressure measured provide another saliva sample and complete the DRUID impairment app They will re-rate their anxiety stress and mood using 0 to 10 visual analog rating scales and the PANAS They will also rate the drug effects intoxication drug effects drug liking and they will re-rate the potential side effects dry mouth dry eyes sleepiness increased appetite nausea heart palpitationsracing heart dizziness To capture other potential side effects they will be asked if they are experiencing any other physiological or psychological symptoms in an open-ended manner and to rate the severity of each on 0 not at all to 10 severe rating scales
T2 Assessments Next participants will engage in a modified version of the Maastricht Acute Stress Test MAST to determine whether CBG modifies responses to stress Specifically participants will complete three cold pressor trials in which they will be instructed to hold their hand in cold water 0 degrees for 3 minutes They will be informed they can remove their hand if it becomes too painful and the duration of time that they keep their hand in the cold pressor on each trial will be used as an objective measure of pain tolerance After each trial participants will subjectively rate the severity of pain they experienced using 0 to 10 visual analog rating scales Between the three cold pressor trials participants will be instructed to count backward from 2043 by 17s as quickly and as accurately as possible When they make an error they will receive negative feedback and will be instructed to start the mental arithmetic over again
After the MAST participants will provide a third blood pressure assessment and saliva sample and will complete another trial of the DRUID app They will re-rate their anxiety stress and mood using 0 to 10 visual analog rating scales and the PANAS They will also re-rate subjective drug effects and side effects using 0 to 10 visual analog rating scales and an open-ended question
T3 Assessments Next participants will complete a short battery of memory tests Specifically they will complete the California Verbal Learning Test the Deese-Roediger-McDermott paradigm the Digit Span Forwards Test and the Digit Span Backwards Test
After the memory tests participants will be asked to provide a fourth blood pressure assessment and saliva sample and will complete the DRUID app They will re-rate their mood anxiety and stress and will complete the PANAS They will re-rate subjective drug effects and potential side effects including answering an open-ended question about perceived side effects with follow-up severity ratings
Finally participants will complete a brief survey to assess their cannabis and CBG use patterns
Testing Session 2 After a one-week washout period participants will complete the second testing session which will be identical to the first session except for the product they will ingest Specifically those that ingested the 50 mg CBG tincture in Session 1 will ingest the 50 mg placebo tincture in Session 2 and those that ingested the placebo in Session 1 will ingest the CBG tincture in Session 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None