Smoked Cannabis Effects Study
(S-TACOFS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of California, Los Angeles
Must not be taking: Illicit drugs, others
Disqualifiers: Substance use disorder, Axis I, others
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of delta-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.
Will I have to stop taking my current medications?
The trial requires that you do not use any medications that may affect the study outcomes. If you are currently taking such medications, you may need to stop them to participate.
What data supports the effectiveness of the drug in the Smoked Cannabis Effects Study?
Research shows that cannabidiol (CBD) has anxiolytic (anxiety-reducing) and antipsychotic effects when taken in high doses, and it may also interact with THC to influence pain relief and movement. Additionally, CBD has been used effectively in treating epilepsy, as seen with the FDA-approved drug Epidiolex.
12345Is smoked cannabis generally safe for humans?
Research shows that cannabidiol (CBD), a component of cannabis, is generally safe with most side effects being mild to moderate, such as sedation and sleep disturbances. However, there are potential serious adverse effects, especially when interacting with other medications, so caution and monitoring are advised.
46789How is the Smoked Cannabis Effects Study drug different from other treatments?
This study explores the effects of smoked cannabis with different combinations of CBD and THC, which is unique because it uses vaporization to achieve faster effects compared to traditional oral administration. The combination of CBD and THC aims to balance the psychoactive effects of THC with the calming effects of CBD, offering a potentially novel approach to treatment.
210111213Eligibility Criteria
This trial is for men and women aged 21-55 who are not pregnant or breastfeeding, with a BMI of 18.5-34kg/m2, use cannabis weekly to monthly without seeking treatment, and agree to use contraception. Excluded are those with significant illness, other substance abuse disorders besides nicotine/caffeine, current heavy medication users, or those with respiratory issues.Inclusion Criteria
If you have a Body Mass Index (BMI) between 18.5 and 34 kg/m2, you are considered to be within the healthy weight range.
I have used cannabis once a week or less in the past month.
I am a man or a woman not pregnant or breastfeeding, aged 21-55.
+6 more
Exclusion Criteria
Currently enrolled in another research protocol
My doctor has checked my health history and found no issues with using cannabis.
Have you used cannabis / marijuana in the last month?
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive inhaled cannabis with varying amounts of THC and CBD, and placebo, to assess pharmacokinetics and pharmacodynamics
6 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1-2 weeks
Participant Groups
The study tests the effects of inhaled cannabis by comparing placebo (no THC/CBD), just THC (20 mg), just CBD (20 mg), and a combination of THC and CBD (20 mg each). It aims to understand how these substances affect the body and how they can be detected in oral fluid after smoking.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 20 mg THCExperimental Treatment1 Intervention
Smoked cannabis with THC
Group II: 20 mg CBD + 20 mg THCExperimental Treatment1 Intervention
Smoked cannabis with CBD and THC
Group III: 20 mg CBDExperimental Treatment1 Intervention
Smoked cannabis with CBD
Group IV: PlaceboPlacebo Group1 Intervention
Smoked placebo cannabis
CBD Cannabis is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Epidiolex for:
- Severe myoclonic epilepsy in infancy (Dravet syndrome)
- Lennox-Gastaut syndrome
🇺🇸 Approved in United States as Epidiolex for:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
🇨🇦 Approved in Canada as Sativex for:
- Central neuropathic pain in multiple sclerosis
- Cancer-related pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
References
Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. [2020]This review aims to present completed clinical trial data surrounding the medicinal benefits and potential side effects of the increasingly popular cannabidiol (CBD)-based drug products, specifically Epidiolex. The article is divided into two sections based on if the ailment being treated by this cannabinoid is classified as either physiological or neurological conditions. In addition to describing the current status, we also examined the different primary and secondary outcomes recorded for each study, which varies greatly depending on the funding source of the clinical trial. With the recent FDA-approval of Epidiolex, this review mainly focused on trials involving this specific formulation since it is the only CBD-based drug currently available to clinicians, although all other clinically trialed CBD(A) drugs were also examined. We hope this review will help guide future research and clinical trials by providing the various outcomes measured in a single review.
A protocol for the delivery of cannabidiol (CBD) and combined CBD and ∆9-tetrahydrocannabinol (THC) by vaporisation. [2022]Significant interest has emerged in the therapeutic and interactive effects of different cannabinoids. Cannabidiol (CBD) has been shown to have anxiolytic and antipsychotic effects with high doses administered orally. We report a series of studies conducted to determine the vaporisation efficiency of high doses of CBD, alone and in combination with ∆9-tetrahydrocannabinol (THC), to achieve faster onset effects in experimental and clinical trials and emulate smoked cannabis.
White matter integrity after cannabidiol administration for treatment resistant epilepsy. [2022]The effects of individual cannabinoids on white matter integrity are unclear. Human studies have shown white matter maturation alterations in regular recreational cannabis users with the magnitude of these effects dependent on the age of exposure. However, studies have yet to determine which phytocannabinoids are most responsible for these changes. In the current study, we analyzed the effects of pharmaceutical grade cannabidiol oral solution (CBD; Epidiolex® in the U.S.; Epidyolex® in the EU; 100 mg/mL oral solution) on white matter integrity using diffusion MRI in patients with treatment resistant epilepsy (TRE).
A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. [2021]The pharmacokinetics (PK) and safety of single oral 750-mg doses of a plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex in the USA and Epidyolex in Europe; 100-mg/mL oral solution) were assessed in healthy adults following a high-fat/calorie meal (n = 15), a low-fat/calorie meal (n = 14), whole milk (n = 15), or alcohol (n = 14), relative to the fasted state (n = 29).
Cannabidiol-Δ9-tetrahydrocannabinol interactions on acute pain and locomotor activity. [2018]Label="BACKGROUND">Previous studies suggest that cannabidiol (CBD) may potentiate or antagonize Δ9-tetrahydrocannabinol's (THC) effects. The current study examined sex differences in CBD modulation of THC-induced antinociception, hypolocomotion, and metabolism.
Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]Cannabidiol (CBD) is a multitarget agent possessing anti-inflammatory and antioxidant properties. Unlicensed CBD gained public favor for the care of general health and well-being as well as to get comfort from inflammatory complaints, pain, anxiety, mood, and sleep disorders. Safety profile of unlicensed CBD has been not sufficiently described. For this reason, suspected adverse reactions (SARs) to CBD unlicensed products were analyzed. Serious SARs to unlicensed CBD products in EudraVigilance, a system purchased by the European Medicines Agency, were analyzed for age, sex of the patient, adverse reactions, indication for use, and concomitant drugs. Serious SARs were 18.9% of all adverse events to unlicensed CBD; they were more frequent in men and adult people and, to a less extent, in children (3-11 years). About sex, in EudraVigilance serious Individual Cases Safety Reports of SARs to CBD in men are in the largest number (58.8%) with respect to women. Unlicensed CBD was used in the 38.8% of cases for treatment of epilepsy; more frequent adverse effects were: mental disorders, hepatic disorders, and aggravation of pre-existing epilepsy. Drugs or substances more frequently associated with SARs were the antiepileptics clobazam and valproic acid, followed by cannabis. Results suggest that precautions and appropriate surveillance of adverse effects should be taken when unlicensed CBD is used.
Serious adverse effects of cannabidiol (CBD): a review of randomized controlled trials. [2022]Recent trials using cannabidiol (CBD) have shown that most acute and prolonged adverse effects of CBD are mild to moderate, with rare serious adverse effects (SAEs). This review focused on analyzing SAEs of CBD and their possible relation to drug-drug interactions.
Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]Cannabidiol (CBD) is ubiquitous in state-based medical cannabis programs and consumer products for complementary health or recreational use. CBD has intrinsic pharmacologic effects and associated adverse drug events (ADEs) along with the potential for pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs). Given CBD use among patients with complex conditions and treatment regimens, as well as its expanded consumer use, awareness of potential safety issues with CBD is needed. Prescribing information for federally approved products containing CBD were reviewed. Data on ADEs and DDIs were extracted and summarized. Nearly one-half of CBD users experienced ADEs, which displayed a general dose-response relationship. Common ADEs include transaminase elevations, sedation, sleep disturbances, infection, and anemia. Given CBD effects on common biological targets implicated in drug metabolism (e.g., CYP3A4/2C19) and excretion (e.g., P-glycoprotein), the potential for DDIs with commonly used medication is high. General clinical recommendations of reducing substrate doses, monitoring for ADEs, and finding alternative therapy should be considered, especially in medically complex patients. CBD is implicated as both a victim and perpetrator of DDIs and has its own ADE profile. These effects should be considered in the risk-benefit assessment of CBD therapy and patients and consumers made aware of potential safety issues with CBD use.
Long-term efficacy and safety of cannabidiol (CBD) in children with treatment-resistant epilepsy: Results from a state-based expanded access program. [2021]An intermediate-sized, multicenter, expanded-access study was opened in 2015 through the support of the State of Georgia. This study provided children with treatment-resistant epilepsy (TRE) access to plant-derived highly purified cannabidiol (CBD; Epidiolex® in the US; Epidyolex® in the EU; 100 mg/mL oral solution). These children had failed to achieve seizure freedom with available treatment options and were ineligible to participate in randomized controlled trials that only included patients with Lennox-Gastaut and Dravet syndromes.
Cannabis: Drug of Abuse and Therapeutic Agent, Two Sides of the Same Coin. [2023]The consumption of Cannabis sativa plant, known as marijuana in the Western world, for different purposes (therapeutic, intoxicating, and spiritual) due to its psychoactive effects, can be traced back to ancient times. Cannabis is the most used illicit drug worldwide; however, its legal status is changing rapidly. Cannabis regulation will allow a better understanding of its effects as a misused drug, including new challenges, such as the availability of highly potent Cannabis extracts. Furthermore, scientific research is making significant efforts to take advantage of the potential therapeutic uses of Cannabis active compounds. The science of Cannabis derivatives started with the identification of the phytocannabinoids Δ9-tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD), allowing the formal study of the complex set of effects triggered by Cannabis consumption and the deciphering of its pharmacology. Δ9-THC is recognized as the compound responsible for the psychoactive and intoxicating effects of Cannabis. Its study led to the discovery of the endocannabinoid system, a neuromodulatory system widespread in the human body. CBD does not induce intoxication and for that reason, it is the focus of the search for cannabinoid potential clinical applications. This review examines the current state of knowledge about contrasting perspectives on the effects of Cannabis, Δ9-THC, and CBD: their abuse liability and potential therapeutic use; two sides of the same coin.
Pharmacodynamic effects of vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis in infrequent cannabis users. [2022]The use and availability of oral and inhalable products containing cannabidiol (CBD) as the principal constituent has increased with expanded cannabis/hemp legalization. However, few controlled clinical laboratory studies have evaluated the pharmacodynamic effects of oral or vaporized CBD or CBD-dominant cannabis.
Changes in delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) concentrations in cannabis over time: systematic review and meta-analysis. [2022]Cannabis products with high delta-9-tetrahydrocannabinol (THC) concentrations carry an increased risk of addiction and mental health disorders, while it has been suggested that cannabidiol (CBD) may moderate the effects of THC. This study aimed to systematically review and meta-analyse changes in THC and CBD concentrations in cannabis over time (PROSPERO registration: CRD42019130055).
Cannabidiol in humans-the quest for therapeutic targets. [2022]Cannabidiol (CBD), a major phytocannabinoid constituent of cannabis, is attracting growing attention in medicine for its anxiolytic, antipsychotic, antiemetic and anti-inflammatory properties. However, up to this point, a comprehensive literature review of the effects of CBD in humans is lacking. The aim of the present systematic review is to examine the randomized and crossover studies that administered CBD to healthy controls and to clinical patients. A systematic search was performed in the electronic databases PubMed and EMBASE using the key word "cannabidiol". Both monotherapy and combination studies (e.g., CBD + ∆9-THC) were included. A total of 34 studies were identified: 16 of these were experimental studies, conducted in healthy subjects, and 18 were conducted in clinical populations, including multiple sclerosis (six studies), schizophrenia and bipolar mania (four studies), social anxiety disorder (two studies), neuropathic and cancer pain (two studies), cancer anorexia (one study), Huntington's disease (one study), insomnia (one study), and epilepsy (one study). Experimental studies indicate that a high-dose of inhaled/intravenous CBD is required to inhibit the effects of a lower dose of ∆9-THC. Moreover, some experimental and clinical studies suggest that oral/oromucosal CBD may prolong and/or intensify ∆9-THC-induced effects, whereas others suggest that it may inhibit ∆9-THC-induced effects. Finally, preliminary clinical trials suggest that high-dose oral CBD (150-600 mg/d) may exert a therapeutic effect for social anxiety disorder, insomnia and epilepsy, but also that it may cause mental sedation. Potential pharmacokinetic and pharmacodynamic explanations for these results are discussed.