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

Trial Summary

What is the purpose of this trial?

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.

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.

What evidence supports the effectiveness of the treatment 15% THC Potency Reduction, 35% THC Potency Reduction for cognitive impairment from cannabis use?

The research suggests that reducing cannabis use can lead to functional improvements, and lower THC doses are associated with less cognitive impairment. This implies that reducing THC potency might help improve cognitive function in cannabis users. ^{1 2 3 4 5}

Is reduced-THC cannabis generally safe for humans?

Cannabis use can cause side effects like increased heart rate, low blood pressure when standing, lung irritation if smoked, coordination problems, memory issues, anxiety, and paranoia. People with heart, lung, or mental health issues should be cautious. Monitoring during use is important to ensure safety. ^{2 6 7 8 9}

How does reduced-THC cannabis differ from other treatments for cognitive impairment due to cannabis use?

Reduced-THC cannabis is unique because it contains lower levels of THC, the main psychoactive component of cannabis, which is known to impair cognitive functions like memory and attention. This approach aims to minimize these cognitive effects while still providing potential therapeutic benefits, unlike traditional cannabis products that often have higher THC concentrations. ^{2 4 10 11 12}

Research Team

Veronika Mesheriakova, MD

Principal Investigator

University of California, San Francisco

Michael Sofis, PhD

Principal Investigator

Cannabis Public Policy Consulting

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Measuring Within-Individual Cannabis Reduction in Clinical Trials: A Review of the Methodological Challenges. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive test performance in chronic cannabis flower users, concentrate users, and non-users. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Duration of Neurocognitive Impairment With Medical Cannabis Use: A Scoping Review. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Cannabis-induced cognitive and psychiatric disorders]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Effects of acute smoked marijuana on complex cognitive performance. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Methods for clinical research involving cannabis administration. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A First-Tier Framework for Assessing Toxicological Risk from Vaporized Cannabis Concentrates. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of CannEpil® on simulated driving performance and co-monitoring of ocular activity: A randomised controlled trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility and effects of galantamine on cognition in humans with cannabis use disorder. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Disposable screen printed sensor for the electrochemical detection of delta-9-tetrahydrocannabinol in undiluted saliva. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

The effects of acute Cannabis smoke or Δ9-THC injections on the trial-unique, nonmatching-to-location and five-choice serial reaction time tasks in male Long-Evans rats. [2022]