Systematically Testing the Evidence on Marijuana

The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.

First Posted: March 16, 2021

Condition(s): Impairment, Cannabis Intoxication

Intervention(s): EyeBOX

Status: Completed

Enrollment (expected or actual): 225

Allocation:

Sponsor: Oculogica, Inc.

Principal Investigator:

Completion Date (primary or actual): September 7, 2021

CT.gov Identifier: NCT04799093

Glatt Pharmaceutical Services GmbH & Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the new product is expected to show increased bioavailability, reduced variability especially in the fasted state and better robustness towards food interaction compared to oil-based cannabidiol solutions. The aim of the present clinical trial is the characterisation of maximum systemic exposure of CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated target effective dose for treatment of COVID-19 as well as the comparison of its systemic bioavailability to CBD administered as oily solution. Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions with twice daily intake after a light meal over 7 consecutive days.

First Posted: March 10, 2021

Condition(s): Comparative Bioavailability

Intervention(s): GLA-015, DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"

Status: Completed

Enrollment (expected or actual): 18

Allocation: Randomized

Sponsor: SocraTec R&D GmbH

Principal Investigator:

Completion Date (primary or actual): April 16, 2021

CT.gov Identifier: NCT04790136

Suicide is a major crisis worldwide with rates projected to continue to increase. There is currently a dearth of novel pharmacologic treatment options for suicide available on the market. The endocannabinoid system has been recently shown to be associated with mood disorders including suicidality. The aim of the study is to determine whether treatment with Nabilone is capable of reducing suicidal ideation in adults after 3 days.

First Posted: March 19, 2021

Condition(s): Suicidal Ideation

Intervention(s): Nabilone, Placebo

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: The University of Texas Health Science Center, Houston

Principal Investigator: Rodrigo Machado-Vieira, MD, PhD, MSc, Professor of Psychiatry

Completion Date (primary or actual): April 2022

CT.gov Identifier: NCT04807829

Self-medication of pain by consuming alcohol and marijuana is common. However, the research regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain induction paradigms with limited clinical relevance. The study will assess demand for alcohol and marijuana before and after delayed onset muscle soreness (DOMS) induction in co-users. This will provide a clinically relevant, but time-limited, model for the effects of musculoskeletal pain on demand.

First Posted: March 10, 2021

Condition(s): Chronic Pain

Intervention(s): Eccentric Biceps Flexion, Concentric Biceps Flexion

Status: Completed

Enrollment (expected or actual): 51

Allocation: Randomized

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): May 10, 2022

CT.gov Identifier: NCT04791917

This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers.

First Posted: March 2, 2021

Condition(s): CBD, Neural Responses

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Yale University

Principal Investigator:

Completion Date (primary or actual): February 28, 2024

CT.gov Identifier: NCT04777643

Chronic pain affects at least 10% of the global population but is often poorly managed, given the variable efficacy of available pharmacological treatments and the limited accessibility of multidisciplinary interventions. The legalization of cannabis in at least 14 countries and the increasing regulatory approval of cannabis preparations and synthetic cannabinoids and analogues have led to a growing interest in the use of medical cannabis products to manage chronic pain. This use is supported by research demonstrating important interactions between cannabinoids and the human endocannabinoid system and pain modulation pathways. While medical cannabis products are increasingly available to practitioners who treat pain, there is little evidence-based guidance for prescribing or titrating these treatments to manage chronic non-cancer pain. This prospective registry aims to assemble real-world data regarding the use of Spectrum Therapeutics (ST) medical cannabis products in subjects with chronic non-cancer pain in Canada. The registry will also assess treatment outcomes, including pain and related symptoms, global impressions of improvement, and change in concomitant pain medications (opioid use in particular), to better inform the utility of ST products for chronic non-cancer pain management. Primary Objective: • To describe patterns of physician selection of Spectrum Therapeutics (ST) medical cannabis treatment regimen, expressed as average daily dose of THC and CBD (in mg), and mode of administration (ingested or inhaled), in the management of chronic non-cancer pain in countries where these products are commercially available. Secondary Objectives: To describe subject product and dose adjustment (under medical follow-up) over time. To assess outcomes of treatment, including pain relief and effects on sleep, daily functioning, and quality of life. To assess global impressions of treatment effectiveness as reported by subjects and physicians. To assess changes in daily dose of opioids, other medications over time. Safety Objective: • To assess the safety and tolerability of ST products in subjects with chronic pain.

First Posted: February 21, 2021

Condition(s): Chronic Pain

Intervention(s): Spectrum Therapeutics cannabis products

Status: Active, not recruiting

Enrollment (expected or actual): 500

Allocation:

Sponsor: Canopy Growth Corporation

Principal Investigator:

Completion Date (primary or actual): July 30, 2023

CT.gov Identifier: NCT04763252

Study of Cannabidol to examine the safety and efficacy of 15 weeks of CBD in postmenopausal women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Investigators are looking to see if patients with joint pain see improvement with the use of CBD.

First Posted: February 15, 2021

Condition(s): Arthralgia, Breast Cancer

Intervention(s): Cannabidiol (CBD)

Status: Completed

Enrollment (expected or actual): 40

Allocation: N/A

Sponsor: University of Michigan Rogel Cancer Center

Principal Investigator:

Completion Date (primary or actual): October 10, 2023

CT.gov Identifier: NCT04754399

This double-blind, placebo-controlled, exploratory trial is designed to compare effects of oral CBD 600mg to placebo (PCB) in 20 outpatients with chronic spinal radiculopathies (without co-occurring Opioid Use Disorder), maintained on stable opioid analgesics for a minimum of 1 month. The trial duration will be approximately 2 weeks (from the point of randomization) of daily CBD 600mg vs placebo. Safety and tolerability of CBD will be assessed throughout the trial. The secondary efficacy outcome is change in pain outcomes from baseline to end of the treatment period at 2-weeks post-randomization/initiation of treatment with a Mixed Model for Repeated Measures (MMRM) statistical analysis performed to assess between group treatment effects of CBD relative to placebo.

First Posted: February 18, 2021

Condition(s): Radiculopathy

Intervention(s): Cannabidiol, Placebo

Status: Completed

Enrollment (expected or actual): 14

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): June 7, 2023

CT.gov Identifier: NCT04760613

A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.

First Posted: August 13, 2021

Condition(s): Pain, Sleep Disturbance, Anxiety

Intervention(s): Commercially available, orally ingestible CBD product

Status: Completed

Enrollment (expected or actual): 3000

Allocation:

Sponsor: Radicle Science

Principal Investigator:

Completion Date (primary or actual): October 30, 2021

CT.gov Identifier: NCT05003882

The purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. The study will help us learn about ways to deliver wellness information in a way that is appealing and helpful to young people that use social media. Eligible participants will be enrolled after baseline survey is completed. Participants will be involved with the secret social media group they are assigned to for 8 weeks. In addition, surveys will be completed at various times during and after the 8 week social media group.

First Posted: May 26, 2021

Condition(s): Cannabis Use

Intervention(s): Physical Activity (PA) Social Media Group, Verdi plus PA Social Media Group

Status: Completed

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: University of Michigan

Principal Investigator: Erin Bonar, Associate Professor of Psychiatry, Medical School and Adjunct Associate Professor of Psychology

Completion Date (primary or actual): December 25, 2021

CT.gov Identifier: NCT04901910

In light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future RCTs examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient population. Epidiolex®, an oral cannabidiol (CBD) solution, is the first ever cannabis-derived medication to be approved by the Food & Drug Administration. Our aim is to conduct a pilot study using a placebo oral solution, 400mg and 800mg Epidiolex® to gather data on its effects on patients undergoing bilateral total knee arthroplasty (BTKA). We will be estimating whether Epidiolex® is associated with minimal opioid use and adequate analgesia. We will also assess its tolerability, pharmacokinetics, and effects on inflammatory markers in the perioperative setting.

First Posted: February 11, 2021

Condition(s): Pain, Postoperative, Opioid Use, Knee Osteoarthritis

Intervention(s): cannabidiol, Ora-sweet SF

Status: Recruiting

Enrollment (expected or actual): 36

Allocation: Randomized

Sponsor: Hospital for Special Surgery, New York

Principal Investigator:

Completion Date (primary or actual): January 2024

CT.gov Identifier: NCT04749628

Smoking cigarettes remains the number one preventable cause of death and disease in the US. Smokers who call tobacco quitlines and use marijuana struggle to quit tobacco due to the interactive effects of nicotine and marijuana. A recent study found that 25% of callers to state quitlines said they were using marijuana and 44% of those were interested in quitting or cutting back their marijuana use (in addition to wanting to quit smoking). The investigators propose to develop an integrated intervention for co-users of marijuana and tobacco to be delivered via state-funded quitlines. The investigators will incorporate key elements of an evidence-based brief behavioral intervention called 'The Marijuana Check-Up' into the tobacco quitline treatment. The investigators will evaluate the feasibility, acceptability and preliminary effects of the new intervention in a small randomized pilot study with 100 co-users recruited from four participating state quitlines. Outcomes measured at 3 months post randomization will include tobacco abstinence (biochemically verified) and days used marijuana. The investigators hypothesize that the intervention will: (1) be feasible to deliver (measured by coach treatment fidelity scores); (2) be acceptable to co-users (measured by enrollments into the study and call completion numbers); (3) increase tobacco cessation rates compared with standard quitline treatment; (4) increase co-users motivation to change MJ use; and (5) produce greater reduction in days using MJ compared with standard quitline treatment. The proposed brief behavioral intervention addressing co-use may increase quitline callers' chances of achieving and maintaining tobacco abstinence and increase participants' motivation to reduce marijuana use. As non-medicinal marijuana use becomes common and legal in more states, a low touch phone and web-based intervention for co-users of marijuana and tobacco could improve health outcomes for many. Findings will inform development of scalable public health intervention strategies for co-users easily implemented across quitlines.

First Posted: February 4, 2021

Condition(s): Smoking Cessation, Marijuana Use

Intervention(s): Behavioral: Quitline treatment as usual, QL Marijuana Check-Up intervention (QL-MJCU)

Status: Recruiting

Enrollment (expected or actual): 136

Allocation: Randomized

Sponsor: Consumer Wellness Solutions

Principal Investigator:

Completion Date (primary or actual): December 1, 2022

CT.gov Identifier: NCT04737772

This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).

First Posted: February 9, 2021

Condition(s): Autism Spectrum Disorder

Intervention(s): GWP42003-P, Placebo

Status: Active, not recruiting

Enrollment (expected or actual): 160

Allocation: Randomized

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): December 22, 2023

CT.gov Identifier: NCT04745026

The goal of this double-blinded randomized controlled trial is to compare whether the addition of Dronabinol compared to a placebo will affect opioid intake in patients undergoing a total knee arthroplasty. The main question it aims to answer are: Does perioperative dronabinol use (starting in the immediate preoperative period (enrollment before 1 PM), with BID dosing concluding the evening of POD2) affect postoperative opioid consumption 24-48 hours following total knee arthroplasty? Is there an effect of perioperative dronabinol use in the total knee arthroplasty patient on POD2 pain scores with ambulation? Will hospital length of stay following total knee arthroplasty be affected in patients who use perioperative dronabinol as compared to control? Does the use of perioperative dronabinol affect time to reach physical therapy discharge goals in postoperative total knee arthroplasty patients? Is there a change in number of postoperative oxygen desaturation events in patients following total knee arthroplasty based on perioperative dronabinol use? Participants will: Be randomized to take the dronabinol or placebo medication in 5 dosage Answer survey questions in regard to pain, postop nausea/vomiting, cognitive/adverse event, and outcome quality and support of decision making. Be connected to a Masimo to record oxygen saturation and an Actigraph to record sleep quality. Researchers will compare two groups: 1) intervention group and 2) control group to see if dronabinol affect postoperative opioid consumption 24-48 hours following their total knee arthroplasty surgery.

First Posted: February 2, 2021

Condition(s): Total Knee Arthroplasty, Opioid Use

Intervention(s): Dronabinol 5mg Cap, Placebo oral tablet

Status: Active, not recruiting

Enrollment (expected or actual): 114

Allocation: Randomized

Sponsor: Hospital for Special Surgery, New York

Principal Investigator:

Completion Date (primary or actual): October 6, 2023

CT.gov Identifier: NCT04734080

The purpose of this study is to evaluate the effects of administering CBD to control post-operative pain in patients undergoing ankle fracture open reduction and internal fixation, tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation or intramedullary nail fixation), or tibial plateau open reduction and internal fixation. Secondly, the purpose is to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.

First Posted: February 24, 2021

Condition(s): Ankle Fractures, Tibia Fracture

Intervention(s): CBD, Placebo

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): October 1, 2023

CT.gov Identifier: NCT04768478

This study compares patients' attitudes regarding marijuana products for medical use and other treatments for cancer-related pain. This study may help researchers gain better understanding of patient's perception on their use of marijuana products in treating cancer-related pain and other common cancer-related symptoms.

First Posted: May 6, 2021

Condition(s): Cancer-Associated Pain, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention(s): Electronic Health Record Review, Questionnaire Administration

Status: Recruiting

Enrollment (expected or actual): 250

Allocation:

Sponsor: M.D. Anderson Cancer Center

Principal Investigator:

Completion Date (primary or actual): February 2, 2027

CT.gov Identifier: NCT04875286

With this study, the investigators will address the following scientific aims: Demonstrate the antidepressant effects of CBD in human adults with treatment refractory MDD as measured by standard rating scales. Confirm CBD's safety profile in human adult patients with MDD.

First Posted: February 1, 2021

Condition(s): Treatment Resistant Depression

Intervention(s): Active study drug ( oral CBD), matching placebo

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: University of Alabama at Birmingham

Principal Investigator: Matthew Macaluso, Bee McWane Reid Professor, Department of Psychiatry & Behavioral Neurobiology

Completion Date (primary or actual): July 9, 2021

CT.gov Identifier: NCT04732169

Current management of COVID-19 (coronavirus) is mainly supportive, and respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with severe acute respiratory syndrome (SARS). Cannabidiol (CBD), a nonpsychotropic ingredient of Cannabis sativa, possesses potent anti-inflammatory and immunosuppressive properties. These effects are mediated by T cell attrition and by inhibition of pro-inflammatory cytokine release (tumor necrosis factor-a, Interferon gamma, IL-1b, IL-6, and IL-17) and stimulation of anti-inflammatory cytokine production (IL-4, IL-5, IL-10, and IL-13). In a number of phase 2 trials involving more than 100 patients, our group was able to show the safety and efficacy of CBD in the prevention and treatment of graft-versus-host disease. Based on these data, we will test the cytokine profile, safety and efficacy of CBD treatment in patients with severe and critical COVID-19 infection.

First Posted: January 29, 2021

Condition(s): COVID-19

Intervention(s): Cannabidiol

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: N/A

Sponsor: Rabin Medical Center

Principal Investigator: moshe yeshurun, Head BMT Unit

Completion Date (primary or actual): December 31, 2021

CT.gov Identifier: NCT04731116

Cannabidiol (CBD) is one of 700 chemicals derived from the Cannabis sativa plant and is both legal and widespread for distribution in the state of Vermont. The central hypothesis of this proposal is that in apparently healthy adults, acute CBD favorably affects the autonomic nervous system and that this will be evident by an increase in heart rate variability. The overall goal is to understand how CBD affects the autonomic and cardiovascular systems at rest, and when perturbed. The investigators will study a narrow age range of adults, administer varying acute doses of CBD, characterize baseline cardiovascular variables, and record responses to autonomic challenge maneuvers. This will provide the framework to assess potential therapies and/or risk factors of CBD, particularly as it relates to healthy individuals. More information that is so widely taken, especially one that targets receptors known to be involved in cardiovascular signaling pathways is imperative.

First Posted: February 1, 2021

Condition(s): Healthy

Intervention(s): cannabidiol, Placebo

Status: Completed

Enrollment (expected or actual): 18

Allocation: Randomized

Sponsor: Castleton University

Principal Investigator: Andrea Corcoran, Assistant Professor of Exercise Science

Completion Date (primary or actual): November 29, 2021

CT.gov Identifier: NCT04731779

Fibromyalgia is serious chronic pain condition which is often accompanied by sleep disturbances, fatigue and disability and reduced quality of life. There is no cure and treatments are based on reliving symptoms and maintaining function. The currently available medical treatments are not helping many patients, and many get side-effects. Medical cannabis is sought after among patients and many use this medication un-licenced, although it is not properly documented if it works or is safe. Therefore, it is necessary to investigate the effects and safety of medical cannabis in a properly designed randomized trial. The aim of the study is to investigate if cannabidiol (CBD) can improve pain, sleep, function and quality of life in patients with fibromyalgia. The study will include 200 patients, who will receive either cannabidiol or placebo over a period of 24 weeks. Participants will be closely looked after for improvements in their condition and for potential side-effects to ensure safety.

First Posted: January 28, 2021

Condition(s): Fibromyalgia

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: Randomized

Sponsor: Marius Henriksen

Principal Investigator: Marius Henriksen, Professor

Completion Date (primary or actual): December 1, 2023

CT.gov Identifier: NCT04729179

Cannabis use disorder (CUD) is a significant and expanding health problem, and no FDA approved treatments are currently available. Persons with posttraumatic stress disorder (PTSD) may use cannabis to help control symptoms. Relief from PTSD insomnia, nightmares, anxiety, and preoccupying thoughts have been reported as troublesome symptoms targeted by cannabis users. Risks from cannabis use by individuals with PTSD have been reported. Chronic use of cannabis can lead to tolerance, requiring increased use for symptom relief, and withdrawal symptoms upon stopping. CUD is more frequent and severe in those with PTSD than those without. Many symptoms of cannabis withdrawal overlap with troubling symptoms of PTSD and thus may be interpreted as a relapse of PTSD symptoms. Those attempting to reduce or stop cannabis use may experience cannabis withdrawal symptoms including insomnia and distressing dreams, anxiety, irritability, and/or excessive sweating that they may misattribute to re-emerging or untreated PTSD symptoms. Excessive brain adrenaline activity is arguably the best-described neurobiological contribution to the pathophysiology of PTSD. Prazosin, a drug that blocks the negative effects of brain adrenaline, has demonstrated effectiveness in robustly reducing PTSD-related nightmares and sleep disturbance in active duty Servicemembers and recently discharged combat Veterans in most, but not all, clinical trials, as well as in civilians with non-combat trauma. Clinically, the investigators have observed that several patients with PTSD using cannabis to treat insomnia and/or trauma-related nightmares and wanting to reduce their cannabis use were able to achieve reduction or cessation of cannabis use once they were treated with an effective dose of prazosin. Therefore, we have wondered if prazosin may provide sufficient treatment of PTSD symptoms otherwise targeted by cannabis, supporting those individuals' efforts to reduce cannabis use. This open-label pilot study aims to study the feasibility of prazosin as a treatment for CUD in individuals with or without comorbid PTSD, and to evaluate if additional research on a larger scale is warranted.

First Posted: January 22, 2021

Condition(s): Cannabis Dependence, Posttraumatic Stress Disorder, Cannabis Use Disorder

Intervention(s): Prazosin Hydrochloride

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: N/A

Sponsor: University of Washington

Principal Investigator: Garth Terry, Assistant Professor, School of Medicine

Completion Date (primary or actual): December 31, 2024

CT.gov Identifier: NCT04721353

The purpose of this research study is to test how a medication called nabilone (Cesamet) affects neurocognitive processes involved in obsessive-compulsive disorder (OCD), including threat response, processing of fear signals, and habitual behavior. OCD is a disabling illness that affects around 2% of the population and involves recurrent intrusive thoughts (obsessions) and repetitive behaviors (compulsions) that lead to distress and/or impaired functioning. Nabilone is a synthetic form of delta-9-tetrahydrocannabinol (THC, the primary psychoactive component of the cannabis plant). It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD symptoms. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD. In this study, 60 adults with OCD will receive a single dose of either nabilone or placebo. Participants will then complete a series of assessments including neuroimaging, psychophysiology (e.g., skin conductance recording), computerized behavioral tasks, and self-report measures. The information gained from this study could contribute to the development of new treatments for people with OCD and related disorders.

First Posted: May 10, 2021

Condition(s): Obsessive-Compulsive Disorder

Intervention(s): Nabilone, Placebo

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: New York State Psychiatric Institute

Principal Investigator: Reilly R. Kayser, Medical Director, Center for OCD and Related Disorders

Completion Date (primary or actual): July 1, 2026

CT.gov Identifier: NCT04880278

This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1. Several drugs including: steroids, intravenous Gama globulin, Clobazam, other benzodiazepines, Valproic acid, and other anti-epileptic drugs have been tried with mixed benefits2,3. Cannabidiol (CBD) would provide a novel mechanism of action to assess for its efficacy in this population. This will be a double-blind placebo-controlled crossover clinical trial.

First Posted: January 25, 2021

Condition(s): Electrical Status Epilepticus of Slow-Wave Sleep

Intervention(s): Epidiolex 100 mg/mL Oral Solution, Placebo

Status: Recruiting

Enrollment (expected or actual): 34

Allocation: Randomized

Sponsor: Northwell Health

Principal Investigator: Sanjeev Vithal Kothare, Director, Service Line Chief of Child Neurology

Completion Date (primary or actual): January 2024

CT.gov Identifier: NCT04721691

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

First Posted: January 11, 2021

Condition(s): Cannabis

Intervention(s): Inhaled THC, Placebo

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: Yale University

Principal Investigator: Mohini Ranganathan, Associate Professor of Psychiatry

Completion Date (primary or actual): June 1, 2024

CT.gov Identifier: NCT04704271

Nigella sativa is the world's oldest immunomodulator. The main active component in Nigella sativa is thymoquinone. Research shows thymoquinone has antioxidant, anti-inflammatory, and antimicrobial effects. Based on these observations on the pharmacological activities of Nigella sativa, the potential therapeutic efficacy of N. Sativa was proposed in CAP.

First Posted: July 19, 2023

Condition(s): Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia

Intervention(s): Nigella Sativa Oil capsule

Status: Not yet recruiting

Enrollment (expected or actual): 104

Allocation: Randomized

Sponsor: Rehab Zaki Elmeazawy

Principal Investigator: Rehab Zaki Elmeazawy, Doctor

Completion Date (primary or actual): May 2024

CT.gov Identifier: NCT05952102