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Funding has ended; seeking additional funding to continue
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| Name | Class |
|---|---|
| Advocates for Human Potential | INDUSTRY |
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The goal of this interventional study is to determine the impact of high potency THC product use on cognitive function of young adults aged 21-25.
The main question it aims to answer is: will cannabis users who switch to less potent THC products demonstrate improved cognitive function compared to baseline?
Other questions this study aims to answer include:
Participants will submit blood and urine samples and be incentivized to use less potent THC products.
The goal of this interventional study is to determine the impact of high potency THC product use on cognitive function of young adults aged 21-25.
The aims aims of this study are:
Participants will:
Researchers will compare if participants in each group are able to use less potent THC products and whether the use of less potent THC products results in improved cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15% THC Potency Reduction Group | Experimental | Participants will be incentivized to use THC products that are at least 15% less potent than baseline |
|
| 35% THC Potency Reduction Group | Experimental | Participants will be incentivized to use THC products that are at least 35% less potent than baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15% THC Potency Reduction | Behavioral | Participants will be incentivized to use THC products that are at least 15% less potent than baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rapid Visual Information Processing Score | Cognitive performance will be assessed using the CANTAB, a computer-based cognitive assessment system. Participants in this study will complete a battery of seven neuropsychological tests. CANTAB is administered to subjects using a touch screen computer and is language- and culture- independent. Participants scores at 5 weeks will be compared to their baseline scores. The Rapid Visual Information Processing test takes 9 minutes to complete and is scored on a scale of 0-54, with a higher score indicative of better cognitive performance. | Baseline and 5 weeks |
| Change in Paired Associates Learning score | Cognitive performance will be assessed using the CANTAB, a computer-based cognitive assessment system. Participants in this study will complete a battery of seven neuropsychological tests. CANTAB is administered to subjects using a touch screen computer and is language- and culture- independent. Participants scores at 5 weeks will be compared to their baseline scores. The Paired Associates Learning test takes 8 minutes to complete and is scored on a scale of 0-100%, with a higher percentage indicative of better cognitive performance. | Baseline and 5 weeks |
| Change in Delayed Matching-to-Sample Score | Cognitive performance will be assessed using the CANTAB, a computer-based cognitive assessment system. Participants in this study will complete a battery of seven neuropsychological tests. CANTAB is administered to subjects using a touch screen computer and is language- and culture- independent. Participants scores at 5 weeks will be compared to their baseline scores. The Delayed Matching-to-Sample test takes 7 minutes to complete and is scored on a scale of 0-100%, with a higher percentage indicative of better cognitive performance. | Baseline and 5 weeks |
| Change in Verbal Recognition Memory score | Cognitive performance will be assessed using the CANTAB, a computer-based cognitive assessment system. Participants in this study will complete a battery of seven neuropsychological tests. CANTAB is administered to subjects using a touch screen computer and is language- and culture- independent. Participants scores at 5 weeks will be compared to their baseline scores. The Verbal Recognition Memory test takes 6 minutes to complete and is scored on a scale of 0-36, with a higher score indicative of better cognitive performance |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Urinary THC Excretion | Urinary THC excretion will be measured using liquid chromatography mass spectroscopy (LC/MS/MS). THC levels will be corrected/standardized for level of hydration by dividing total THC by total urine creatinine. Results range from <5 ng/mL to 5,000 ng/mL, with higher values indicative of more THC in the urine. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary THC Excretion in CYP2C9*3 carriers | Predisposition to poorly metabolize THC will be measured at baseline using a blood test to identify carriers of the CYP2C9*3 genetic variant. We will then determine whether there are statistically significant differences in baseline and weekly urinary THC levels among CYP2C9*3 carriers compared to non-carriers while controlling for participant reported cannabis use patterns. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronika Mesheriakova, MD | University of California, San Francisco | Principal Investigator |
| Michael Sofis, PhD | Cannabis Public Policy Consulting | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19005461 | Background | Sachse-Seeboth C, Pfeil J, Sehrt D, Meineke I, Tzvetkov M, Bruns E, Poser W, Vormfelde SV, Brockmoller J. Interindividual variation in the pharmacokinetics of Delta9-tetrahydrocannabinol as related to genetic polymorphisms in CYP2C9. Clin Pharmacol Ther. 2009 Mar;85(3):273-6. doi: 10.1038/clpt.2008.213. Epub 2008 Nov 12. | |
| 27717258 |
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| ID | Term |
|---|---|
| D000074609 | Marijuana Use |
| D060825 | Cognitive Dysfunction |
| D000072137 | Vaping |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| 35% THC Potency Reduction | Behavioral | Participants will be incentivized to use THC products that are at least 35% less potent than baseline |
|
| Baseline and 5 weeks |
| Change in Spatial Working Memory score | Cognitive performance will be assessed using the CANTAB, a computer-based cognitive assessment system. Participants in this study will complete a battery of seven neuropsychological tests. CANTAB is administered to subjects using a touch screen computer and is language- and culture- independent. Participants scores at 5 weeks will be compared to their baseline scores. The Spatial Working Memory test takes 4 minutes to complete and is scored on a scale of 0-306, with a lower score indicative of fewer errors and better cognitive performance. | Baseline and 5 weeks |
| Change in One-Touch Stockings of Cambridge score | Cognitive performance will be assessed using the CANTAB, a computer-based cognitive assessment system. Participants in this study will complete a battery of seven neuropsychological tests. CANTAB is administered to subjects using a touch screen computer and is language- and culture- independent. Participants scores at 5 weeks will be compared to their baseline scores. The One-Touch Stockings of Cambridge test takes 10 minutes to complete and scores are based on the time it takes for a participant to solve 20 problems. Shorter time to solve a problem is indicative of better cognitive performance. | Baseline and 5 weeks |
| Change in Stop Signal Task score | Cognitive performance will be assessed using the CANTAB, a computer-based cognitive assessment system. Participants in this study will complete a battery of seven neuropsychological tests. CANTAB is administered to subjects using a touch screen computer and is language- and culture- independent. Participants scores at 5 weeks will be compared to their baseline scores. The Stop Signal Task test takes 14 minutes to complete and is scored on a scale of 1-1000 milliseconds, with a shorter time indicative of better cognitive performance. | Baseline and 5 weeks |
| Week 1 Urinary THC Excretion | Urinary THC excretion will be measured using liquid chromatography mass spectroscopy (LC/MS/MS). THC levels will be corrected/standardized for level of hydration by dividing total THC by total urine creatinine. Results range from <5 ng/mL to 5,000 ng/mL, with higher values indicative of more THC in the urine. Week 1 THC levels will be compared to baseline urine THC levels. | 7-10 days after study enrollment. |
| Week 2 Urinary THC Excretion | Urinary THC excretion will be measured using liquid chromatography mass spectroscopy (LC/MS/MS). THC levels will be corrected/standardized for level of hydration by dividing total THC by total urine creatinine. Results range from <5 ng/mL to 5,000 ng/mL, with higher values indicative of more THC in the urine. Week 2 THC levels will be compared to baseline THC levels. | 14-17 days after study enrollment. |
| Week 3 Urinary THC Excretion | Urinary THC excretion will be measured using liquid chromatography mass spectroscopy (LC/MS/MS). THC levels will be corrected/standardized for level of hydration by dividing total THC by total urine creatinine. Results range from <5 ng/mL to 5,000 ng/mL, with higher values indicative of more THC in the urine. Week 3 THC levels will be compared to baseline THC levels. | 21-24 days after study enrollment. |
| Week 4 Urinary THC Excretion | Urinary THC excretion will be measured using liquid chromatography mass spectroscopy (LC/MS/MS). THC levels will be corrected/standardized for level of hydration by dividing total THC by total urine creatinine. Results range from <5 ng/mL to 5,000 ng/mL, with higher values indicative of more THC in the urine. Week 4 THC levels will be compared to baseline THC levels. | 28-30 days after study enrollment. |
| Week 5 Urinary THC Excretion | Urinary THC excretion will be measured using liquid chromatography mass spectroscopy (LC/MS/MS). THC levels will be corrected/standardized for level of hydration by dividing total THC by total urine creatinine. Results range from <5 ng/mL to 5,000 ng/mL, with higher values indicative of more THC in the urine. Week 5 THC levels will be compared to baseline THC levels. | 35-38 days after study enrollment. |
| Baseline |
| Cognitive Performance in CYP2C9*3 carriers | Predisposition to poorly metabolize THC will be measured at baseline using a blood test to identify carriers of the CYP2C9*3 genetic variant. We will then determine whether there are statistically significant differences in baseline and 5-week cognitive performance between CYP2C9*3 carriers compared to non-carriers while controlling for participant reported cannabis use patterns. Cognitive performance will be assessed using the CANTAB, a computer-based cognitive assessment system. Participants in this study will complete a battery of seven neuropsychological tests. CANTAB is administered to subjects using a touch screen computer and is language- and culture- independent. Participants scores at 5 weeks will be compared to their baseline scores, with lower scores indicating more severe cognitive impairment. | Baseline |
| Change in Cannabis Use Disorder Identification Identification Test (CUDIT) score | Symptoms of a cannabis use disorder will be assessed at baseline using the Cannabis Use Disorder Identification Test (CUDIT). CUDIT scores range from 0 to 32, with a score of 12 or higher indicative of possible cannabis use disorder. | Baseline and 5 weeks |
| Change in participant reported depression symptoms | Symptoms of depression will be assessed at baseline and at 5 weeks using the Beck Depression Inventory (BDI). The BDI consists of 21 questions, with scores ranging from 0 to 63; a higher score is indicative of more symptoms of depression. Participant scores at 5 weeks will be compared to their baseline scores. | Baseline and 5 weeks |
| Baseline Participant Reported Cannabis Use | Participants will complete a baseline survey to determine their pattern of cannabis use one week prior to study enrollment. They will be asked to report the brand, name, and THC concentration of the cannabis product(s) they have been using. They will be able to upload photos of product packaging if available. They will be asked to report frequency of cannabis use by reporting whether they used their cannabis product in the morning, afternoon, and evening of each of the preceding 7 days. | Baseline |
| Week 1 Participant Reported Cannabis Use | Participants will complete a baseline survey to determine their pattern of cannabis use 7 days after study enrollment. They will be asked to report the brand, name, and THC concentration of the cannabis product(s) they have been using over the 7 preceding days. They will be asked to upload photos of product packaging. They will be asked to report frequency of cannabis use by reporting whether they used their cannabis product in the morning, afternoon, and evening of each of the preceding 7 days. THC concentration and frequency of use will be compared to baseline cannabis use. | 7 days after study enrollment |
| Week 2 Participant Reported Cannabis Use | Participants will complete a baseline survey to determine their pattern of cannabis use 14 days after study enrollment. They will be asked to report the brand, name, and THC concentration of the cannabis product(s) they have been using over the 7 preceding days. They will be asked to upload photos of product packaging. They will be asked to report frequency of cannabis use by reporting whether they used their cannabis product in the morning, afternoon, and evening of each of the preceding 7 days. THC concentration and frequency of use will be compared to baseline cannabis use. | 14 days after study enrollment |
| Week 3 Participant Reported Cannabis Use | Participants will complete a baseline survey to determine their pattern of cannabis use 21 days after study enrollment. They will be asked to report the brand, name, and THC concentration of the cannabis product(s) they have been using over the 7 preceding days. They will be asked to upload photos of product packaging. They will be asked to report frequency of cannabis use by reporting whether they used their cannabis product in the morning, afternoon, and evening of each of the preceding 7 days. THC concentration and frequency of use will be compared to baseline cannabis use. | 21 days after study enrollment |
| Week 4 Participant Reported Cannabis Use | Participants will complete a baseline survey to determine their pattern of cannabis use 28 days after study enrollment. They will be asked to report the brand, name, and THC concentration of the cannabis product(s) they have been using over the 7 preceding days. They will be asked to upload photos of product packaging. They will be asked to report frequency of cannabis use by reporting whether they used their cannabis product in the morning, afternoon, and evening of each of the preceding 7 days. THC concentration and frequency of use will be compared to baseline cannabis use. | 28 days after study enrollment |
| Week 5 Participant Reported Cannabis Use | Participants will complete a baseline survey to determine their pattern of cannabis use 35 days after study enrollment. They will be asked to report the brand, name, and THC concentration of the cannabis product(s) they have been using over the 7 preceding days. They will be asked to upload photos of product packaging. They will be asked to report frequency of cannabis use by reporting whether they used their cannabis product in the morning, afternoon, and evening of each of the preceding 7 days. THC concentration and frequency of use will be compared to baseline cannabis use. | 35 days after study enrollment |
| Baseline Adapted Cannabis Purchase Task | The relative value of cannabis products used by participants during this trial will be assessed using the adaptive cannabis purchase task. Specifically, participants will be asked to report the largest amount of their preferred cannabis product they would "purchase" at a series of price points using visual analog scales. Participants will respond by placing a mark on the line to indicate their purchase amount, and responses will be anchored by 'none' and 'all of it' and will be coded as values 0-100. Higher values are indicative of higher value attributed to the cannabis product being used. | Baseline |
| Week 1 Adaptive Cannabis Purchase Task | The relative value of cannabis products used by participants during this trial will be assessed using the adaptive cannabis purchase task. Specifically, participants will be asked to report the largest amount of their preferred cannabis product they would "purchase" at a series of price points using visual analog scales. Participants will respond by placing a mark on the line to indicate their purchase amount, and responses will be anchored by 'none' and 'all of it' and will be coded as values 0-100. Higher values are indicative of higher value attributed to the cannabis product being used. | 7 days after study enrollment |
| Week 2 Adaptive Cannabis Purchase Task | The relative value of cannabis products used by participants during this trial will be assessed using the adaptive cannabis purchase task. Specifically, participants will be asked to report the largest amount of their preferred cannabis product they would "purchase" at a series of price points using visual analog scales. Participants will respond by placing a mark on the line to indicate their purchase amount, and responses will be anchored by 'none' and 'all of it' and will be coded as values 0-100. Higher values are indicative of higher value attributed to the cannabis product being used. | 14 days after study enrollment |
| Week 3 Adaptive Cannabis Purchase Task | The relative value of cannabis products used by participants during this trial will be assessed using the adaptive cannabis purchase task. Specifically, participants will be asked to report the largest amount of their preferred cannabis product they would "purchase" at a series of price points using visual analog scales. Participants will respond by placing a mark on the line to indicate their purchase amount, and responses will be anchored by 'none' and 'all of it' and will be coded as values 0-100. Higher values are indicative of higher value attributed to the cannabis product being used. | 21 days after study enrollment |
| Week 4 Adaptive Cannabis Purchase Task | The relative value of cannabis products used by participants during this trial will be assessed using the adaptive cannabis purchase task. Specifically, participants will be asked to report the largest amount of their preferred cannabis product they would "purchase" at a series of price points using visual analog scales. Participants will respond by placing a mark on the line to indicate their purchase amount, and responses will be anchored by 'none' and 'all of it' and will be coded as values 0-100. Higher values are indicative of higher value attributed to the cannabis product being used. | 28 days after study enrollment |
| Week 5 Adaptive Cannabis Purchase Task | The relative value of cannabis products used by participants during this trial will be assessed using the adaptive cannabis purchase task. Specifically, participants will be asked to report the largest amount of their preferred cannabis product they would "purchase" at a series of price points using visual analog scales. Participants will respond by placing a mark on the line to indicate their purchase amount, and responses will be anchored by 'none' and 'all of it' and will be coded as values 0-100. Higher values are indicative of higher value attributed to the cannabis product being used. | 35 days after study enrollment |
| Baseline Participant Reported Cannabis Withdrawal Symptoms | Symptoms of cannabis withdrawal will be assessed using the Cannabis Withdrawal Scale (CWS). The CWS consists of 19 questions and assesses withdrawal symptoms as well as the impact of the symptoms on daily activities. The personal experience score ranges from 0-190, with a higher score indicative of more withdrawal symptoms. The negative experience score ranges from 0-190, with a higher number indicative of more negative impact on daily activities. | Baseline |
| Week 5 Participant Reported Cannabis Withdrawal Symptoms | Symptoms of cannabis withdrawal will be assessed using the Cannabis Withdrawal Scale (CWS). The CWS consists of 19 questions and assesses withdrawal symptoms as well as the impact of the symptoms on daily activities. The personal experience score ranges from 0-190, with a higher score indicative of more withdrawal symptoms. The negative experience score ranges from 0-190, with a higher number indicative of more negative impact on daily activities. | 35 days after study enrollment |
| Baseline Participant Reported Affect | Positive and negative emotions will be assessed using the Positive and Negative Affect Scale (PANAS), which consists of 20 questions, 10 questions assessing positive emotions, and 10 questions assessing negative emotions. Each set of questions is scored on a scale of 10-50, with a higher score indicative of more positive or negative emotions, respectively. | Baseline |
| Week 1 Participant Reported Affect | Positive and negative emotions will be assessed using the Positive and Negative Affect Scale (PANAS), which consists of 20 questions, 10 questions assessing positive emotions, and 10 questions assessing negative emotions. Each set of questions is scored on a scale of 10-50, with a higher score indicative of more positive or negative emotions, respectively. | 7 days after study enrollment |
| Week 2 Participant Reported Affect | Positive and negative emotions will be assessed using the Positive and Negative Affect Scale (PANAS), which consists of 20 questions, 10 questions assessing positive emotions, and 10 questions assessing negative emotions. Each set of questions is scored on a scale of 10-50, with a higher score indicative of more positive or negative emotions, respectively. | 14 days after study enrollment |
| Week 3 Participant Reported Affect | Positive and negative emotions will be assessed using the Positive and Negative Affect Scale (PANAS), which consists of 20 questions, 10 questions assessing positive emotions, and 10 questions assessing negative emotions. Each set of questions is scored on a scale of 10-50, with a higher score indicative of more positive or negative emotions, respectively. | 21 days after study enrollment |
| Week 4 Participant Reported Affect | Positive and negative emotions will be assessed using the Positive and Negative Affect Scale (PANAS), which consists of 20 questions, 10 questions assessing positive emotions, and 10 questions assessing negative emotions. Each set of questions is scored on a scale of 10-50, with a higher score indicative of more positive or negative emotions, respectively. | 28 days after study enrollment |
| Week 5 Participant Reported Affect | Positive and negative emotions will be assessed using the Positive and Negative Affect Scale (PANAS), which consists of 20 questions, 10 questions assessing positive emotions, and 10 questions assessing negative emotions. Each set of questions is scored on a scale of 10-50, with a higher score indicative of more positive or negative emotions, respectively. | 35 days after study enrollment |
| Murray RM, Quigley H, Quattrone D, Englund A, Di Forti M. Traditional marijuana, high-potency cannabis and synthetic cannabinoids: increasing risk for psychosis. World Psychiatry. 2016 Oct;15(3):195-204. doi: 10.1002/wps.20341. |
| 16572123 | Background | Ramaekers JG, Kauert G, van Ruitenbeek P, Theunissen EL, Schneider E, Moeller MR. High-potency marijuana impairs executive function and inhibitory motor control. Neuropsychopharmacology. 2006 Oct;31(10):2296-303. doi: 10.1038/sj.npp.1301068. Epub 2006 Mar 29. |
| 31615592 | Background | D'Souza DC, Ganesh S, Cortes-Briones J, Campbell MH, Emmanuel MK. Characterizing psychosis-relevant phenomena and cognitive function in a unique population with isolated, chronic and very heavy cannabis exposure. Psychol Med. 2020 Oct;50(14):2452-2459. doi: 10.1017/S0033291719002721. Epub 2019 Oct 16. |
| 33783029 | Background | Bidwell LC, Martin-Willett R, Karoly HC. Advancing the science on cannabis concentrates and behavioural health. Drug Alcohol Rev. 2021 Sep;40(6):900-913. doi: 10.1111/dar.13281. Epub 2021 Mar 30. |
| 34177633 | Background | Bourque J, Potvin S. Cannabis and Cognitive Functioning: From Acute to Residual Effects, From Randomized Controlled Trials to Prospective Designs. Front Psychiatry. 2021 Jun 10;12:596601. doi: 10.3389/fpsyt.2021.596601. eCollection 2021. |
| D019965 |
| Neurocognitive Disorders |
| D012907 | Smoking |
| D064419 | Chemically-Induced Disorders |