Reduced-THC Cannabis for Cognitive Impairment from Cannabis Use

(THC-YA Trial)

Overseen By Alison Giovanelli, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnant, Regular drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether young adults who regularly use cannabis can improve their thinking skills by switching to less potent THC products. Researchers compare two groups: one using cannabis that is 15% less potent and another using products that are 35% less potent. The goal is to determine if reducing THC levels can alleviate cognitive issues linked to high-potency cannabis use. Participants should be 21-25 years old, live in San Francisco, and use cannabis concentrates almost daily. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance cognitive health for cannabis users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on cannabis use, so it's best to discuss your specific situation with the trial organizers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that cannabis with lower THC levels can have less impact on thinking and memory, suggesting it might be safer for the brain than high-THC products. Research indicates that heavy cannabis users often experience memory problems, but using cannabis with less THC could help reduce these issues.

One study found that people who used cannabis with lower THC performed better on memory tests than those using stronger cannabis. This finding suggests that reducing THC levels might lessen negative effects on the brain.

Overall, cannabis with less THC is generally considered safer for brain health, with fewer negative effects on memory and attention compared to high-THC products. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the reduced-THC cannabis treatments because they offer a new approach to managing cognitive impairment from cannabis use. Unlike most treatments that may focus on counseling or abstinence, these treatments involve a gradual reduction in THC potency, which could help users decrease their intake without the abrupt challenges of quitting altogether. By incentivizing the use of cannabis with 15% and 35% lower THC levels, these methods aim to maintain user engagement while potentially minimizing cognitive harm. This strategy could provide a more manageable pathway for individuals looking to reduce their THC consumption and its associated cognitive effects.

What evidence suggests that this trial's treatments could be effective for cognitive impairment from cannabis use?

Research has shown that strong cannabis use is linked to worse memory. One study found that people who use cannabis, whether in flower or concentrate form, performed worse on memory tests compared to non-users. Another large study found that 63% of heavy cannabis users showed less brain activity during memory tasks. In this trial, participants will join either the 15% THC Potency Reduction Group or the 35% THC Potency Reduction Group. Reducing THC levels by 15% or 35% might improve thinking and memory, as heavy use is associated with memory problems. Lowering THC could enhance attention and memory by mitigating these negative effects. ^{1 2 3 4 6}

Who Is on the Research Team?

Veronika Mesheriakova, MD

Principal Investigator

University of California, San Francisco

Michael Sofis, PhD

Principal Investigator

Cannabis Public Policy Consulting

Are You a Good Fit for This Trial?

This trial is for young adults aged 21-25 in San Francisco who use cannabis concentrates daily or almost daily, buying only from regulated stores. It's not for pregnant individuals or those regularly using drugs other than nicotine.

Inclusion Criteria

You have self-reported consuming cannabis daily or near-daily during the past 4 weeks.

I am between 21 and 25 years old.

You declare only acquiring cannabis from authorized retail outlets in California.

Exclusion Criteria

Pregnant

You take medications on a regular basis, except for nicotine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo baseline assessment of cognitive performance and submit blood and urine samples to assess genetic variation in THC metabolism and baseline urinary THC excretion.

1 week

1 visit (in-person)

Treatment

Participants are randomized into two groups and incentivized to use less potent THC products. Weekly urine samples and follow-up surveys are conducted to assess cannabis use patterns and cognitive performance.

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive performance and THC metabolism after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 15% THC Potency Reduction
• 35% THC Potency Reduction

Trial Overview The study tests if switching to cannabis with lower THC potency (15% and 35% reductions) improves cognitive function in frequent users. It includes blood and urine tests to assess THC consumption and its effects on cognition.

How Is the Trial Designed?

Group I: 35% THC Potency Reduction Group Experimental Treatment 1 Intervention

Participants will be incentivized to use THC products that are at least 35% less potent than baseline

Group II: 15% THC Potency Reduction Group Experimental Treatment 1 Intervention

Participants will be incentivized to use THC products that are at least 15% less potent than baseline

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Cannabis Public Policy Consulting

Collaborator

Trials

1

Recruited

110+

Advocates for Human Potential

Industry Sponsor

Published Research Related to This Trial

Reducing the number of days individuals use cannabis is linked to improvements in their overall functioning, suggesting that this could be a valuable outcome measure in treatment trials for cannabis use disorder (CUD).

While reductions in the amount of cannabis used showed inconsistent links to functional improvements, biologically-confirmed reductions in usage frequency may serve as a reliable endpoint for future clinical trials, highlighting the need for further research on quantifying cannabis reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Within-Individual Cannabis Reduction in Clinical Trials: A Review of the Methodological Challenges. Tomko, RL., Gray, KM., Huestis, MA., et al.[2022]

In a study involving 198 healthy adults, both cannabis flower users and concentrate users showed worse performance on memory tests compared to non-users, indicating some cognitive impairment associated with regular cannabis use.

Interestingly, there were no significant cognitive differences between flower and concentrate users, suggesting that concentrate users may self-regulate their intake, leading to similar cognitive outcomes as flower users when sober.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive test performance in chronic cannabis flower users, concentrate users, and non-users. Cuttler, C., Petrucci, AS., LaFrance, EM.[2023]

Clinical studies on cannabis administration are essential for understanding its effects and developing treatments for cannabis dependence, with different methods of administration (smoking, oral, intravenous) each having unique safety and efficacy profiles.

Acute adverse effects from cannabis can include tachycardia, cognitive impairment, and anxiety, necessitating careful screening and monitoring of participants to ensure safety during research studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for clinical research involving cannabis administration. Gorelick, DA., Heishman, SJ.[2019]

A standardized dose of CannEpil, a medicinal cannabis oil, did not significantly impair overall driving performance but did lead to increased variability in speed and weaving during a simulated drive, particularly noticeable between 20 and 30 minutes after administration.

Changes in eye behavior, such as increased fixation duration and altered blink patterns, suggest that eye tracking could be a useful tool for assessing cannabis-related driver impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of CannEpil® on simulated driving performance and co-monitoring of ocular activity: A randomised controlled trial. Manning, B., Hayley, AC., Catchlove, S., et al.[2023]

The safety of cannabis and cannabinoid medications is a significant concern, and while some safety information can be drawn from recreational use studies, medical and recreational users may experience different effects.

There is a pressing need for long-term safety monitoring of cannabinoid use in patients, as clinical experience is still developing, which will help inform both therapeutic decisions and public policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. Ware, MA., Tawfik, VL.[2019]

This paper introduces a framework for assessing the safety of additives in cannabis concentrates, aimed at helping regulators and manufacturers without extensive toxicological expertise.

Based on data from over 54,000 users of smart vaporization devices, the study suggests a standard consumption assumption of 100 mg per day for cannabis concentrates to facilitate risk assessments of these additives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A First-Tier Framework for Assessing Toxicological Risk from Vaporized Cannabis Concentrates. Vreeke, S., Faulkner, DM., Strongin, RM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06077292

Cannabis THC Potency, Metabolism, and Cognitive ... 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.

2. withpower.com withpower.com/trial/phase-marijuana-abuse-2024-09a85

Reduced-THC Cannabis for Cognitive Impairment from ... In a study involving 198 healthy adults, both cannabis flower users and concentrate users showed worse performance on memory tests compared to non-users, ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06077292

Cannabis THC Potency, Metabolism, and Cognitive ... 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7259587/

A Systematic Review of the Neurocognitive Effects ... Together, these results suggest that heavy cannabis use is associated with modest deficits in verbal memory, but that this does not lead to accelerated ...

5. ccsa.ca ccsa.ca/sites/default/files/2019-04/CCSA-Cannabis-Use-Cognitive-Effects-Report-2019-en.pdf

Regular Use and Cognitive Functioning The acute effects of cannabis include euphoria and relaxation, changes in perception, time distortion, deficits in attention span and memory, body tremors, ...

6. bmj.com bmj.com/content/382/bmj-2022-072348

Balancing risks and benefits of cannabis use: umbrella ... An additional 12 harmful effects were supported by moderate certainty, including negative symptom severity (n=1), and cognitive outcomes (n=11) ...