Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-27 @ 6:23 PM
Study NCT ID:
NCT06077292
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2023-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabis THC Potency, Metabolism, and Cognitive Impairment in Young Adults
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Impacts of THC Potency of Cannabis Concentrates and THC Metabolism on Cognitive Impairment in Young Adults
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THC-YA
Brief Summary:
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:
* Can researchers accurately assess THC consumption among frequent cannabis users?
* Can researchers effectively incentivize cannabis users to use less potent THC products?
* Do genetic variations in THC metabolism impact urinary THC excretion?
* Do genetic variations in THC metabolism impact cognitive performance in cannabis users?
* Are quantitative urinary THC values predictive of cognitive impairment?
* How can researchers use research findings to inform harm reduction practices for people who use cannabis?
Participants will submit blood and urine samples and be incentivized to use less potent THC products.
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:
* Can researchers accurately assess THC consumption among frequent cannabis users?
* Can researchers effectively incentivize cannabis users to use less potent THC products?
* Do genetic variations in THC metabolism impact urinary THC excretion?
* Do genetic variations in THC metabolism impact cognitive performance in cannabis users?
* Are quantitative urinary THC values predictive of cognitive impairment?
* How can researchers use research findings to inform harm reduction practices for people who use cannabis?
Participants will submit blood and urine samples and be incentivized to use less potent THC products.
Detailed Description:
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:
1. Evaluate feasibility of assessing THC consumption, genetic variation in THC metabolism, urinary THC excretion, and cognitive performance in users of high potency cannabis products.
2. Test the effectiveness of an incentivization protocol aimed at encouraging cannabis users to use less potent THC products as a means of harm reduction.
3. Compare group differences between the high and low THC-reduction groups on THC metabolism (urine) and cognitive performance while controlling for any changes in frequency and amount of cannabis used.
4. Identify whether participant predisposition to poorly metabolize THC (i.e., CYP2C9\*3 carriers vs. others) impacts urinary THC excretion in the experimental condition relative to baseline in both groups.
5. Identify whether participant predisposition to poorly metabolize THC (i.e., CYP2C9\*3 carriers vs. others) impacts cognitive performance in the experimental condition relative to baseline in both groups.
6. Determine whether quantitative urinary THC values correlate with measures of cognitive performance.
7. Communicate basic findings regarding relationships between variables and outcomes in the form of a scorecard to help provide harm reduction strategies for youth who use cannabis.
Participants will:
* Undergo a baseline assessment of cognitive performance and will submit blood and urine samples to assess genetic variation in THC metabolism, and baseline urinary THC excretion.
* Be randomized to two groups: 1) lower THC reduction group (incentivized to use THC products that are at least 15% less potent than baseline) and 2) higher THC reduction group (incentivized to use THC products that are at least 35% less potent than baseline) .
* Submit urine samples at baseline and weekly for 5 weeks to measure urinary THC excretion.
* Complete weekly follow up surveys assessing cannabis use patterns, reinforcing value of the cannabis product(s) used, symptoms of cannabis withdrawal, and presence of positive and negative emotions.
* Undergo re-assessment of cognitive performance after 5 weeks of intervention.
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.
The aims aims of this study are:
1. Evaluate feasibility of assessing THC consumption, genetic variation in THC metabolism, urinary THC excretion, and cognitive performance in users of high potency cannabis products.
2. Test the effectiveness of an incentivization protocol aimed at encouraging cannabis users to use less potent THC products as a means of harm reduction.
3. Compare group differences between the high and low THC-reduction groups on THC metabolism (urine) and cognitive performance while controlling for any changes in frequency and amount of cannabis used.
4. Identify whether participant predisposition to poorly metabolize THC (i.e., CYP2C9\*3 carriers vs. others) impacts urinary THC excretion in the experimental condition relative to baseline in both groups.
5. Identify whether participant predisposition to poorly metabolize THC (i.e., CYP2C9\*3 carriers vs. others) impacts cognitive performance in the experimental condition relative to baseline in both groups.
6. Determine whether quantitative urinary THC values correlate with measures of cognitive performance.
7. Communicate basic findings regarding relationships between variables and outcomes in the form of a scorecard to help provide harm reduction strategies for youth who use cannabis.
Participants will:
* Undergo a baseline assessment of cognitive performance and will submit blood and urine samples to assess genetic variation in THC metabolism, and baseline urinary THC excretion.
* Be randomized to two groups: 1) lower THC reduction group (incentivized to use THC products that are at least 15% less potent than baseline) and 2) higher THC reduction group (incentivized to use THC products that are at least 35% less potent than baseline) .
* Submit urine samples at baseline and weekly for 5 weeks to measure urinary THC excretion.
* Complete weekly follow up surveys assessing cannabis use patterns, reinforcing value of the cannabis product(s) used, symptoms of cannabis withdrawal, and presence of positive and negative emotions.
* Undergo re-assessment of cognitive performance after 5 weeks of intervention.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: