Cannabis Use and Perception

(PISCES Trial)

Overseen By Carillon Skrzynski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Boulder

Must not be taking: Substance use, Psychotic disorders

Disqualifiers: Pregnancy, Other drug use, others

Compensation: Varies

Number of Visits: 2

Duration: 1 week

166 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate. We expect that participants will be in this research study for approximately one week. The total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications for substance use or psychotic disorders.

Is cannabis generally safe for human use?

Cannabis use can have side effects like dizziness, fatigue, anxiety, and cognitive impairment. Long-term use may increase the risk of health issues like cardiovascular problems and neuropsychiatric disorders. It's important to consider these risks and consult with a healthcare provider before use. ^{1 2 3 4 5}

How does cannabis use differ from other drug treatments for perception changes?

Cannabis, specifically its active component THC, is unique because it primarily affects perception and mood, causing feelings of being high, relaxed, or sometimes anxious, which are not typical effects of other drugs used for perception changes. Unlike many treatments that target specific brain functions, THC's effects are more about altering subjective experiences and are linked to the body's endocannabinoid system. ^{6 7 8 9 10}

Eligibility Criteria

This study is for individuals who use cannabis, with or without a history of cannabis abuse, and are interested in how it affects their mood, thinking, perception of temperature and pain, as well as heart rate. Participants will be involved for about one week.

Inclusion Criteria

I use CBD+THC or CBD products at least once a month.

Endorsement of at least moderate use of cannabis for coping purposes (≥2.5 on CMMQ)

I am between 21 and 65 years old.

Exclusion Criteria

Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs

I am not pregnant, trying to conceive, or breastfeeding.

Diagnosis or use of medications for substance use or psychotic disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants engage in cannabis use and complete various tasks to assess mood, cognition, perception, and physiological responses

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Water Temperature Variation

Trial Overview The trial is exploring the impact of smoking cannabis on mental and physical responses by varying water temperatures (CW and WW) during tests. It involves two visits over a week totaling around 2.5 hours to complete the tasks.

Participant Groups

Group I: Cold Water Experimental Treatment 1 Intervention

Group II: Warm Water Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Long-term recreational cannabis use may lead to an increased risk of undesirable side effects, challenging the public perception of cannabis as a safe substance.

Despite its medical potential, there is a need for caution and further research into the adverse health effects associated with regular nonprescribed cannabis use, as these risks are often underreported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shifting the Paradigm on Cannabis Safety. Bannigan, P., Evans, JC., Allen, C.[2022]

Cannabinoid-based medicines, particularly THC and CBD, have been associated with common side effects like dizziness and fatigue, and THC may impair cognitive functions and psychomotor skills, which is important for activities like driving.

The safety profiles of cannabinoid-based treatments are complex and require careful consideration of potential drug interactions and individual patient assessments, emphasizing the need for evidence-based prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Considerations in Cannabinoid-Based Medicine. Gottschling, S., Ayonrinde, O., Bhaskar, A., et al.[2020]

Between 2012 and 2017, adverse events (AEs) related to recreational cannabis use in France increased significantly, with reports tripling from 179 to 562 cases, highlighting a growing concern about its safety, particularly among young men aged 18-34.

The study identified a range of AEs, with dependence being the most common (10.1% to 20.3% over the years), and noted the emergence of cannabinoid hyperemesis syndrome, indicating serious health risks associated with chronic cannabis use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of recreational cannabis use reported to the French addictovigilance network (2012-2017). Bouquet, E., Pain, S., Eiden, C., et al.[2021]

Cannabis use is increasing due to decriminalization and legalization, but its adverse effects, including cardiovascular and pulmonary issues, as well as links to malignancy and neuropsychiatric disorders, are becoming more evident despite limited research.

The rise in cannabis use among minors has led to more cases of overdose and toxicity, highlighting concerns about its safety, particularly regarding impaired driving and motor vehicle accidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Impact of Cannabis on Human Health. Chandy, M., Nishiga, M., Wei, TT., et al.[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]

Inhalation of THC using an e-cigarette technology produced significant hypothermic effects in Sprague-Dawley (SD) rats compared to Wistar (WI) rats, indicating strain differences in response to THC despite similar plasma levels of the substance.

The antinociceptive (pain-relieving) effects of inhaled THC were consistent across both rat strains, suggesting that while the hypothermic response varies, the pain-relieving properties of THC remain effective regardless of the strain used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Δ⁹-tetrahydrocannabinol (THC) vapor inhalation in Sprague-Dawley and Wistar rats. Taffe, MA., Creehan, KM., Vandewater, SA., et al.[2022]

In a study involving 217 subjects across 10 different studies, THC was found to evoke distinct subjective effects categorized into three clusters: perception (feeling high), relaxation (drowsiness and mental slowness), and dysphoria (suspicious thoughts).

The feeling of being high was identified as the strongest predictor of THC's effects, suggesting that understanding these subjective experiences can help differentiate the roles of endocannabinoid systems in health and disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profiling the subjective effects of Δ⁹-tetrahydrocannabinol using visual analogue scales. Kleinloog, D., Roozen, F., De Winter, W., et al.[2021]

High doses of THC (8.0 mg/kg) in male rats led to significant decreases in locomotion and body temperature, indicating a strong hypothermic and hypoactive response, likely due to metabolic inhibition in the brain.

Lower doses of THC (0.5 and 2.0 mg/kg) produced milder effects on behavior and temperature, resembling the effects of diazepam, suggesting that THC's impact may vary based on dosage and the state of the animal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral and temperature effects of delta 9-tetrahydrocannabinol in human-relevant doses in rats. Smirnov, MS., Kiyatkin, EA.[2021]

In a study of 168 non-treatment-seeking heavy drinkers, cannabis users experienced a greater reduction in negative feelings when consuming alcohol compared to non-cannabis users, suggesting a unique subjective response to alcohol.

This finding indicates that cannabis use may influence risk factors for developing alcohol use disorder (AUD) by altering how individuals respond emotionally to alcohol, particularly in terms of negative affect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis use and subjective response to alcohol in the human laboratory. Nieto, SJ., Venegas, A., Hudson, J., et al.[2023]

In a study involving 20 participants (10 frequent and 10 occasional marijuana users), different doses of THC (0.2, 0.4, and 0.6 mg/kg) showed minimal impact on objective performance in sensory and perceptual motor tests, indicating that THC does not significantly impair cognitive function.

However, THC produced significant subjective effects, such as changes in mood and perception, especially in occasional users, suggesting that its primary impact may be on the autonomic nervous system rather than higher cognitive processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory, perceptual, motor and cognitive functioning and subjective reports following oral administration of delta9-tetrahydrocannabinol. Peters, BA., Lewis, EG., Dustman, RE., et al.[2020]

References

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

Shifting the Paradigm on Cannabis Safety. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Safety Considerations in Cannabinoid-Based Medicine. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Adverse events of recreational cannabis use reported to the French addictovigilance network (2012-2017). [2021]

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

Adverse Impact of Cannabis on Human Health. [2023]

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

Methods for clinical research involving cannabis administration. [2019]

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

Effects of Δ⁹-tetrahydrocannabinol (THC) vapor inhalation in Sprague-Dawley and Wistar rats. [2022]

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

Profiling the subjective effects of Δ⁹-tetrahydrocannabinol using visual analogue scales. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral and temperature effects of delta 9-tetrahydrocannabinol in human-relevant doses in rats. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

Cannabis use and subjective response to alcohol in the human laboratory. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Sensory, perceptual, motor and cognitive functioning and subjective reports following oral administration of delta9-tetrahydrocannabinol. [2020]