Cannabis Use and Perception
(PISCES Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Boulder
Must not be taking: Substance use, Psychotic disorders
Disqualifiers: Pregnancy, Other drug use, others
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.
12345How 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.
678910Eligibility 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.
+2 more
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
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cold WaterExperimental Treatment1 Intervention
Group II: Warm WaterPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Colorado at BoulderBoulder, CO
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Who Is Running the Clinical Trial?
University of Colorado, BoulderLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Shifting the Paradigm on Cannabis Safety. [2022]The global movement toward legalization of cannabis is resulting in an ever-increasing public perception that cannabis is safe. Cannabis is not the first drug to be available for nonmedical use, nor is it the first to have such an unfounded safety profile. The safety of long-term exposure to phytocannabinoids is misunderstood by, and under reported to, the general public. There is evidence to suggest that long-term use of recreational cannabis may be associated with an increased risk of undesirable side effects. This evidence warrants both appropriate caution from the general public and investment in further research by government and industry sectors that are profiting from the sale of these potent psychoactive agents. There is no doubt that these compounds have medical potential. However, in addition to the medical potential, we must also remain aware of the adverse health effects that are becoming synonymous with recreational cannabis use. This perspective highlights the privileged role that cannabis has as a perceived "safe drug" in society and summarizes some concerning side effects that are becoming associated with regular nonprescribed cannabis use.
Safety Considerations in Cannabinoid-Based Medicine. [2020]Cannabinoids are a diverse class of chemical compounds that are increasingly recognized as potential therapeutic options for a range of conditions. While many studies and reviews of cannabinoids focus on efficacy, safety is much less well reported. Overall assessment of the safety of cannabinoid-based medicines is confounded by confusion with recreational cannabis use as well as different study designs, indications, dosing, and administration methods. However, clinical studies in registered products are increasingly available, and this article aims to discuss and clarify what is known regarding the safety profiles of cannabinoid-based medicines, focusing on the medical and clinical safety evidence and identifying areas for future research. The two most well-studied cannabinoids are Δ9-tetrahydrocannabinol (THC), or its synthetic variants (dronabinol, nabilone), and cannabidiol (CBD). Across diverse indications, dizziness and fatigue are generally the most common adverse events experienced by patients receiving THC or combined THC and CBD. Patients receiving THC may experience adverse cognitive effects and impairment in psychomotor skills, with implications for driving and some occupations, while CBD may help to lower the psychotropic effects of THC when used in combination. Studies on dependency and addiction in a medical context are limited, but have shown inconsistent findings regarding misuse potential. Generally, the recommended route of administration is oral ingestion, as smoking medicinal cannabinoid products potentially releases mutagenic and carcinogenic by-products. There are several potential drug-drug interactions and contraindications for cannabinoid-based medicines, which physicians should account for when making prescribing decisions. The available evidence shows that, as with any other class of pharmaceuticals, cannabinoid-based medicines are associated with safety risks which should be assessed in the context of potential therapeutic benefits. Each patient should be assessed on an individual basis and physicians must rely on informed, evidence-based decision-making when determining whether a cannabinoid-based medicine could be an appropriate treatment option.
Adverse events of recreational cannabis use reported to the French addictovigilance network (2012-2017). [2021]To describe the adverse events (AEs) of recreational cannabis use in France between 2012 and 2017.
Adverse Impact of Cannabis on Human Health. [2023]Cannabis, the most commonly used recreational drug, is illicit in many areas of the world. With increasing decriminalization and legalization, cannabis use is increasing in the United States and other countries. The adverse effects of cannabis are unclear because its status as a Schedule 1 drug in the United States restricts research. Despite a paucity of data, cannabis is commonly perceived as a benign or even beneficial drug. However, recent studies show that cannabis has adverse cardiovascular and pulmonary effects and is linked with malignancy. Moreover, case reports have shown an association between cannabis use and neuropsychiatric disorders. With growing availability, cannabis misuse by minors has led to increasing incidences of overdose and toxicity. Though difficult to detect, cannabis intoxication may be linked to impaired driving and motor vehicle accidents. Overall, cannabis use is on the rise, and adverse effects are becoming apparent in clinical data sets. Expected final online publication date for the Annual Review of Medicine, Volume 75 is January 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
Methods for clinical research involving cannabis administration. [2019]Better scientific understanding of cannabis effects and the development of treatments for cannabis dependence require clinical studies involving cannabis administration. Cannabis can be administered by smoking a plant-derived cigarette or by oral or intravenous administration of delta9-tetrahydrocannabinol (THC), the primary psychoactive chemical in cannabis. The smoked route is most commonly used outside the laboratory, but is subject to wide variation in absorbed dose. Oral synthetic THC is a legally marketed medication (dronabinol), also subject to wide pharmacokinetic variation, but offering a greater safety margin because of slower onset of action and lower potency. Intravenous THC offers precise investigator control of dose and timing. Acute adverse effects of cannabis administration include tachycardia, orthostatic hypotension, pulmonary irritation (if smoked), motor incoordination, cognitive impairment, anxiety, paranoia, and psychosis. Screening of research subjects should identify and exclude those with risk factors for such events, e.g., a history of significant cardiovascular, pulmonary, or psychiatric disorders. Monitoring of subjects during cannabis administration should include heart rate, blood pressure, and mental status. Subjects should not be discharged from research participation until reevaluation has shown that they have returned to baseline status.
Effects of Δ⁹-tetrahydrocannabinol (THC) vapor inhalation in Sprague-Dawley and Wistar rats. [2022]An inhalation system based on e-cigarette technology produces hypothermic and antinociceptive effects of Δ⁹-tetrahydrocannabinol (THC) in rats. Indirect comparison of some prior investigations suggested differential impact of inhaled THC between Wistar (WI) and Sprague-Dawley (SD) rats; thus, this study was conducted to directly compare the strains across inhaled and injected routes of administration. Groups (N = 8 per strain) of age-matched male SD and WI rats were prepared with radiotelemetry devices to measure temperature and then exposed to vapor from the propylene glycol (PG) vehicle or THC (25-200 mg/mL of PG) for 30 or 40 min. Additional studies evaluated effects of THC inhalation on plasma THC (50-200 mg/mL) and nociception (100-200 mg/mL) as well as the thermoregulatory effect of intraperitoneal injection of THC (5-30 mg/kg). Hypothermic effects of THC were more pronounced in SD rats, where plasma levels of THC were identical across strains, under either fixed inhalation conditions or injection of a mg/kg equivalent dose. Strain differences in hypothermia were largest after i.p. injection of THC, with SD rats exhibiting dose-dependent temperature reduction after 5 or 10 mg/kg, i.p. and the WI rats only exhibiting significant hypothermia after 20 mg/kg, i.p. The antinociceptive effects of inhaled THC (100, 200 mg/mL) did not differ significantly across the strains. These studies confirm an insensitivity of WI rats, compared with SD rats, to hypothermia induced by THC following inhalation conditions that produced identical plasma THC and antinociception. Thus, quantitative, albeit not qualitative, strain differences may be obtained when studying thermoregulatory effects of THC. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
Profiling the subjective effects of Δ⁹-tetrahydrocannabinol using visual analogue scales. [2021]The subjective effects of cannabis and its main psychoactive component Δ(9) -tetrahydrocannabinol (THC) have played an important part in determining the therapeutic potential of cannabinoid agonists and antagonists. The effects mainly consist of feeling high, changes in perception, feelings of relaxation and occasionally dysphoric reactions. These effects are captured by two of the most frequently used visual analogue scales (VASs) in clinical (pharmacologic) research to measure subjective effects: VAS Bond and Lader (alertness, calmness and mood) and VAS Bowdle (psychedelic effects). In this analysis, the effects of THC on these VASs were compared within a total of 217 subjects who participated in 10 different studies. Not surprisingly, the item feeling high was found to be the best predictor for the effect of THC. Three separate clusters that describe the spectrum of subjective effects of THC were identified using different statistical methods, consisting of VAS "time", "thoughts" and "high" ("perception"), VAS "drowsy", "muzzy", "mentally slow" and "dreamy" ("relaxation") and VAS "voices", "meaning" and "suspicious" ("dysphoria"). These results provide experimental evidence that THC can evoke different classes of effects. These distinct subjective clusters could represent effects on various systems in the brain, which can be used to further differentiate the involvement of endocannabinoid systems in health and disease.
Behavioral and temperature effects of delta 9-tetrahydrocannabinol in human-relevant doses in rats. [2021]Marijuana smoking dramatically alters responses to various environmental stimuli. To study this phenomenon, we assessed how delta-9-tetrahydrocannabinol (THC), a primary psychoactive ingredient of marijuana, affects locomotor and brain (nucleus accumbens or NAcc), muscle and skin temperature responses to natural arousing stimuli (one-minute tail-pinch and one-minute social interaction with another male rat) and iv cocaine (1 mg/kg) in male rats. THC was administered at three widely varying doses (0.5, 2.0 and 8.0 mg/kg, ip), and the drug-induced changes in basal values and responses to stimuli were compared to those occurring following ip vehicle injections (control). Each stimulus in control conditions caused acute locomotor activation, a prolonged increase in brain and muscle temperature (0.6-1.0 degrees C for 20-50 min) and transient decrease in skin temperature (-0.6 degrees C for 1-3 min). While THC at any dose had a tendency to decrease spontaneous locomotion as well as brain and muscle temperatures, true hypothermia and hypoactivity as well as clearly diminished locomotor and temperature responses to all stimuli were only seen following the largest dose. In this case, temperature decreases in the NAcc were stronger than in the muscle, suggesting metabolic brain inhibition as the primary cause of hypoactivity, hypothermia and hyporesponsiveness. While weaker in strength and without associated vasodilatation, this response pattern is mimicked by general anesthetics, questioning to what extent the hypothermic action of THC is specific (i.e., mediated via endogenous cannabinoid receptors) or non-specific, reflecting drug interaction with membrane lipids or other receptors. In contrast, weaker behavioral and temperature effects of THC at lower doses resemble those of diazepam, whose locomotion- and temperature-decreasing effects are evident only in activated conditions, when rats are moving and basal temperatures are elevated.
Cannabis use and subjective response to alcohol in the human laboratory. [2023]Cannabis is often used in combination with alcohol; yet, whether cannabis use impacts risk factors for alcohol use disorder (AUD) remains unknown. Subjective response (SR) to alcohol represents a biobehavioral risk factor for subsequent heavy drinking and for developing AUD. Given the high prevalence of alcohol and cannabis co-use, it is plausible to hypothesize that cannabis users differ in SR to alcohol compared to non-cannabis users. The purpose of this study is to examine the influence of past-month cannabis use on subjective response to alcohol in the human laboratory.
Sensory, perceptual, motor and cognitive functioning and subjective reports following oral administration of delta9-tetrahydrocannabinol. [2020]Three dose levels, 0.2, 0.4, and 0.6 mg/kg, of delta9-tetrahydrocannabinol (THC) and a placebo were orally administered to 10 frequent and 10 occasional marijuana users. Following ingestion of each dose and the placebo, objective tests selected from a battery of sensory and perceptual motor tests routinely used to evaluate cerebral dysfunction in hospitalized patients were administered. The influence of delta9-THC on proficiency and variability of performance was minimal. However, when individual test scores and variabilities were combined and converted to standard scores, allowing for analysis of overall performance, THC had a small but consistent detrimental effect on both proficiency and variability of performance. In contrast, THC exerted profound effects on the subjective experiences of the volunteers as assessed by the Subjective Drug Effects Questionnaire. Subjective changes in mood, feeling, perception and somatic sensations were reported by all subjects but were more pronounced in the occasional user group. It was proposed that the small impairment noted in objective test performance after ingestion of delta9-THC as contrasted to the large effects on subjective responses suggests that the principal effects of marijuana are on the autonomic nervous system rather than on higher cortical functions.