Systematically Testing the Evidence on Marijuana

This two-phase project seeks to examine the cardiovascular response to consumption of cannabis variants of different cannabinoid composition through different methods (smoking vs. vaporizing), at rest and during aerobic exercise. Multiple measures that have been shown to predict risk factors for chronic-disease and negative health outcomes will be assessed following cannabis consumption at rest or in combination with exercise. These techniques will examine arterial stiffness, vascular function, and cardiac function. In phase I and II, subjects will visit the lab on 6 different occasions; with 1 visit acting as an introductory visit, 1 as an exercise control visit, 2 as resting cannabis visits, and 2 as cannabis + exercise visits. Cannabis used in phase I of this study will consist of approximately 10% THC. On all visits, pulse wave velocity, flow mediated dilation, and echocardiography measures will be performed following cannabis consumption by smoking or vaporizing, and cannabis consumption by smoking or vaporizing followed by 20 minutes of exercise on a cycle ergometer. Phase II of the study will implore a similar design. In favor of altering method of consumption, in all visits cannabis will be consumed by vaporization and will be either a high cannabidiol (CBD: (~10%)) and low delta-9-tetrahydrocannabinol (THC: (<1%)), or a high THC (~10%) and low CBD (<1%) variant.

First Posted: January 5, 2021

Condition(s): Cannabis, Cardiovascular Risk Factor

Intervention(s): Cannabis, Cannabis, Cannabis, Cannabis

Status: Active, not recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Jamie Burr

Principal Investigator: Jamie Burr, Associate Professor

Completion Date (primary or actual): December 2023

CT.gov Identifier: NCT04693884

Heavy cannabis use is associated with substantive learning and memory impairments and elevated risk of psychopathology. It has been repeatedly demonstrated that the hippocampus, centrally implicated in these processes, is particularly vulnerable to the deleterious effects of prolonged exposure to cannabis. This deterioration of hippocampal structure, function, and biochemistry can be reversed, but this requires two or more years of abstinence from cannabis. However, most heavy cannabis users find it extremely difficult to maintain abstinence over extended periods and current treatments for cannabis use disorders are inadequate. There is a pressing clinical need for an intervention that rapidly accelerates hippocampal recovery, ameliorates the associated cognitive impairments and mental health symptoms, and leads to improved treatment outcomes. One promising candidate is physical exercise. In addition to the well-known physical health benefits, regular exercise also has a potent positive effect on brain health. The current study will investitive the capacity of two different neuroscientifically-informed 12-week exercise programs can restore brain health for heavy long term cannabis users.

First Posted: May 26, 2021

Condition(s): Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Intervention(s): High Intensity Interval Training, Strength and Resistance Training

Status: Completed

Enrollment (expected or actual): 65

Allocation: Randomized

Sponsor: Monash University

Principal Investigator: Rebecca Segrave, Senior Research Fellow

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

CT.gov Identifier: NCT04902092

Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients

First Posted: March 1, 2021

Condition(s): Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal Appliance, CBD

Intervention(s): CBD occlusal appliance, Acrylic resin occlusal appliance

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: Medical University of Silesia

Principal Investigator: Aleksandra Nitecka-Buchta, dr n. med.

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

CT.gov Identifier: NCT04775030

Social media based intervention to support teens in their efforts to quit vaping.

First Posted: January 13, 2021

Condition(s): Vaping

Intervention(s): Social Media Intervention

Status: Active, not recruiting

Enrollment (expected or actual): 500

Allocation: Randomized

Sponsor: University of California, San Francisco

Principal Investigator:

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

CT.gov Identifier: NCT04707911

Obesity is a serious health problem which increases the likelihood of developing other life-changing medical conditions. Despite increasing knowledge about the neural and metabolic basis of obesity, the development of effective anti-obesity treatment strategies has been a challenge. Evidence shows an association between cannabis consumption and body weight. However, to date, no human trials have assessed the potential of cannabis-like compounds to reduce body weight in individuals who are obese. This pilot trial aims to determine the safety and feasibility of administering nabilone (a cannabinoid drug similar to the active component of cannabis) to patients who are obese. Our secondary aims are to determine if nabilone is effective in reducing weight in this population, and to probe potential mechanisms of the weight-loss-promoting effects of nabilone, such as neural reactivity to food stimuli, changes in gut bacteria, and changes in metabolic biomarkers.

First Posted: March 17, 2021

Condition(s): Obesity

Intervention(s): Placebo, Nabilone

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): May 2023

CT.gov Identifier: NCT04801641

This is a case series of adult, male and female subjects with androgenetic alopecia (male pattern baldness). A topical hemp oil that is rich in varins (THCV and CBDV) and cannabidiol (CBD) is being used daily for six months to stimulate hair regrowth using Endocannabinoid System (ECS) receptors that are found on hair follicles.

First Posted: April 13, 2021

Condition(s): Androgenetic Alopecia

Intervention(s): Hemp Oil

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: Gregory L Smith, MD, MPH

Principal Investigator: Gregory L Smith, MD, MPH, Primary Investigator

Completion Date (primary or actual): October 4, 2021

CT.gov Identifier: NCT04842383

Fabry Disease (FD) is a rare lysosomal storage disorder due to the absence or deficiency of hydrolase α-galactosidase A (α-Gal A) activity in lysosomes. This dysfunction results in progressive accumulation of glycosphingolipids in a wide variety of cells, resulting in major organ system damage. Patients with Fabry disease can suffer from neuropathic pain, since lysosomal accumulation affects small unmyelinated nerve fibers. Neuropathic pain is one of the prominent and debilitating symptoms significantly interfering with life quality in FD patients. Current treatment of Fabry patients with neuropathic pain is deficient, as they respond poorly to a conventional pain therapy, often require a high-dose opioids treatment and presentation to the Emergency Department. Sativex® has been shown to be a successful treatment option in neuropathic pain of different origin with minimal neuropsychological influence: in multiple sclerosis (MS), chemotherapy-induced neuropathic pain and other. It contains Δ-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) and has recently been licensed in Switzerland for treatment of neuropathic chronic pain in MS. Sativex® is an oral spray.

First Posted: March 29, 2021

Condition(s): Pain, Neuropathic

Intervention(s): Cannabis sativa L., folium cum flore, Placebo

Status: Recruiting

Enrollment (expected or actual): 22

Allocation: Randomized

Sponsor: Albina Nowak, MD

Principal Investigator: Albina Nowak, MD, Sponsorl Investigator

Completion Date (primary or actual): December 29, 2023

CT.gov Identifier: NCT04820361

Cannabidiol (CBD) is another cannabis plant derivative for which, like THC, there has been extensive research. Unlike THC however, CBD is non-intoxicating and non-psychedelic. CBD has antipsychotic effects. Logically, if CBD opposes THC effects, it may be a potential antipsychotic treatment. The purpose of this pilot research is to show target engagement of the hippocampus with the study drug (CBD versus placebo) in patients who have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder with psychosis compared to healthy controls.

First Posted: March 3, 2021

Condition(s): CBD

Intervention(s): CBD, Placebo

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Hartford Hospital

Principal Investigator: Godfrey Pearlson, Founding Director Olin Neuropsychiatry Research Center; Professor Yale University

Completion Date (primary or actual): December 2022

CT.gov Identifier: NCT04778644

This study is designed to evaluate the effects of administering CBD to control post-operative pain in patients undergoing shoulder arthroscopy. Secondly, the purpose will be to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.

First Posted: December 17, 2020

Condition(s): Pain, Postoperative

Intervention(s): CBD Oral Disintegrating Tablet (ODT), Placebo ODT

Status: Completed

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

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

CT.gov Identifier: NCT04672252

The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet than a placebo.

First Posted: December 22, 2020

Condition(s): Diabetic Peripheral Neuropathic Pain

Intervention(s): CBD, Placebo

Status: Recruiting

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Pure Green

Principal Investigator:

Completion Date (primary or actual): March 1, 2021

CT.gov Identifier: NCT04679545

The purpose of this study is to evaulate CBD as a therapeutic approach for dental pain. Eligible subjects presented with emergency dental pain will be give a single dose of Epidiolex (FDA-approved CBD) or placebo and will be monitored for 3 hours for pain symptoms and psychologic effects.

First Posted: November 24, 2020

Condition(s): Odontalgia, Toothache

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

Status: Completed

Enrollment (expected or actual): 64

Allocation: Randomized

Sponsor: The University of Texas Health Science Center at San Antonio

Principal Investigator: Vanessa Chrepa, Assistant Professor of Endodontics

Completion Date (primary or actual): March 2, 2023

CT.gov Identifier: NCT04642404

The purpose of this pilot study is to better understand the effects of chronic cannabis (THC) use on the neural responses to subconcussive head impacts, as a form of repetitive soccer headings. The study is designed to identify the physiological changes of cannabis using cohort (THC) and compare it to a nonusing cohort in order to see if the responses to 20 controlled bouts of soccer headings are exacerbated by the chronic cannabis use, diminished to less of a response, or unchanged, through an array of neurologic measures, including cognitive function, ocolar-motor function, autonomic function, and blood biomarkers. The hypothesis is that repetitive subconcussive head impacts will impair cognitive function in worse memory, attention span, and visual and verbal problem solving; this impairment will be greater in the chronic cannabis use groups than non-using group. The blood and salivary biomarkers neurofilament light (NFL) and glial fibrillary acidic protein (GFAP) will be measured in plasma, with the hypothesis that repetitive subconcussive head impacts will significantly increase plasma NFL and GFAP level at 24 hours-post heading and decrease by 72 hours-post heading, while remaining undetectable at 2 hours-post heading; the chronic cannabis use groups will see more severe effects on ocular-motor function than the non-using group. The study aims to determine the differences in acute effects of subconcussive head impacts on eye movement, attention, and language function between chronic cannabis use subjects and non-using subjects by evaluating ocular-motor function with near point of convergence and King-Devick tests. The hypothesis is that repetitive subconcussive head impacts will significantly increase impairments of eye movements, attention, and language function, as well as near point of convergence; the chronic cannabis use groups will see more severe effects on hampered ocular-motor function than the non-using group. Lastly, there is a cold pressor test to assess autonomic nerve function, with the hypothesis that repetitive subconcussive head impacts will decrease autonomic nerve function in chronic cannabis use patients to a greater degree than non-using subjects.

First Posted: November 24, 2020

Condition(s): Concussion, Mild

Intervention(s): Soccer heading

Status: Completed

Enrollment (expected or actual): 70

Allocation: Non-Randomized

Sponsor: Indiana University

Principal Investigator: Keisuke Kawata, Assistant Professor

Completion Date (primary or actual): October 1, 2021

CT.gov Identifier: NCT04641832

The CANPAIN study has been devised to evaluate the efficacy and safety of a defined cannabis based medicinal product (CBMP) delivered by inhalation to patients with non cancer chronic pain attending a private clinic. CANPAIN is a pragmatic non-randomised, non-blinded real-world trial of the safety, tolerability and effectiveness of a cannabis based medicinal product (CBMP) for the treatment of chronic non-cancer pain compared against matched controls receiving standard of care pain management. CANPAIN will run for 3 years with a minimal planned sample size of 5000 participants per group who have completed at least 12 months of treatment. CANPAIN will be an MHRA and REC approved study. (See Appendix 1 of the Feasibility Study for the full draft protocol of the CANPAIN Study) Prior to commencing the CANPAIN study, the sponsor proposes to conduct a feasibility study. This study will aid in establishing likely rates of patient recruitment, duration of participant enrolment in the study, the demographic and geographic spread of patients, patient acceptability of data collection and identify any issues with technological and drug delivery logistics.

First Posted: March 18, 2022

Condition(s): Chronic Pain

Intervention(s): Cannabis

Status: Enrolling by invitation

Enrollment (expected or actual): 100

Allocation: N/A

Sponsor: Harley Street (CPC) Limited

Principal Investigator:

Completion Date (primary or actual): June 15, 2022

CT.gov Identifier: NCT05288010

Objective of the Protocol: The primary aim of the current protocol is to examine whether or not habitual use of medical marijuana affects psychomotor functioning operationalized as driving performance. Secondary endpoints will examine whether type of medical marijuana used, frequency, dosage or route of administration is associated with adverse effects. The proposed study is a prospective repeated measures experimental study designed to test medical marijuana use as the exposure variable in adults age 50 and older and driving errors in response time, attention, and executive functions as the primary outcome. Secondary outcomes include: adverse effects. Participants will complete 3 assessments over a 3 month time period. The 3 assessment time points are: baseline (T1), prior to starting medical marijuana, 1 month post-medical marijuana initiation (T2), and 3 months post-medical marijuana initiation (T3). Electronic Medical Review (EMR) will be conducted at baseline, 1, and 3 months. In addition, potentially confounding disease, treatment, and sociodemographic characteristics will be examined. Data will be collected in a manner that is consistent with transparent reporting as mandated by CONSORT guidelines. Finite mixture modeling and generalized linear modeling accounting for individual and group level outcomes will be used to test the study hypotheses. The investigators propose to enroll 60 adults (n=30 medical marijuana users and n=30 age, race, sex matched controls) ages 50 and older with chronic/severe non-malignant pain, which is the most common diagnosis for medical marijuana users. Primary Endpoint: Thus, the proposed study will test medical marijuana use as the exposure variable in adults age 50 and older and simulated driving performance (e.g. errors in response time, attention, and executive functioning tasks that predict on-road performance) as the primary outcome. Secondary Endpoint: Further, the investigators will explore the association between medical marijuana use and adverse effects.

First Posted: November 16, 2020

Condition(s): Chronic Pain

Intervention(s): Medical Cannabis

Status: Completed

Enrollment (expected or actual): 44

Allocation:

Sponsor: Florida State University

Principal Investigator: Nicole Ennis, Associate Professor

Completion Date (primary or actual): August 17, 2023

CT.gov Identifier: NCT04629716

The proposed study is a double-blind, placebo-controlled, cross over study on 60 children aged 5 to 25 years with severe spasticity related to cerebral palsy (CP), level IV and V with full-spectrum medical cannabis product of CBD/THC ratio 10:1.

First Posted: November 18, 2020

Condition(s): Children, Adult, Spastic Cerebral Palsy, Quality of Life, Cannabis, Physical Disability

Intervention(s): Lab tests, ECG, Cannabinoid Levels, Full-spectrum Medical Canabis Product (HemPhar), Placebo, Spasticity level according to modified Ashworth scale (Bohannon), Gross Motor Function Measure, Borg rating of perceived exertion scale, Edmonton symptom assessment system

Status: Completed

Enrollment (expected or actual): 55

Allocation: Randomized

Sponsor: University Medical Centre Ljubljana

Principal Investigator: Damjan Osredkar, Associate Professor of Pediatrics

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

CT.gov Identifier: NCT04634136

Tobacco and cannabis co-use is a common and growing public health problem, especially in states that have legalized cannabis. There are no pharmacologic treatments for co-occurring tobacco and cannabis use. Co-use may make quitting either substance more difficult, given the synergistic effects of cannabis and nicotine on neurobiological systems that mediate reward and shared cues reinforcing co-use. N-acetylcysteine (NAC), an FDA-approved medication and over-the-counter supplement, has shown promise in animal studies and randomized controlled trials (RCTs) in reducing tobacco and cannabis craving and use.

First Posted: November 13, 2020

Condition(s): Cannabis Use, Tobacco Use Disorder, Drug Use Disorder

Intervention(s): N-Acetyl cysteine, Placebo comparator, Cognitive behavioral therapy (CBT)

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Ellen Herbst

Principal Investigator: Ellen Herbst, Principal Investigator

Completion Date (primary or actual): August 25, 2024

CT.gov Identifier: NCT04627922

This study will evaluate the pharmacokinetic and pharmacodynamic effects of hemp-based Cannabidiol (CBD) topical products (e.g., lotions, creams, patches) that contain low levels of delta-9-tetrahydrocannabinol (THC).

First Posted: February 5, 2021

Condition(s): Cannabis, Drug Effect

Intervention(s): CBD, THC, Placebo

Status: Completed

Enrollment (expected or actual): 47

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): September 16, 2022

CT.gov Identifier: NCT04741477

Epidermolysis bullosa (EB) is rare, devastating, and currently incurable genetic blistering disorders characterized by fragility of skin and mucosal membranes. Therapeutic options for EB are limited. Acute and chronic wounds cause pain, itching and infection, altering quality of life and impair wound healing. In absence of a cure, wound care is paramount to alleviate suffering. Anecdotal experience suggest that CBD application alleviates the pain and itching and improves wound healing by controlling the inflammatory process. We propose to undertake a phase II/III study exploring the safety, tolerability and efficacy of topical application of 3% Cannabidiol cream (CBD) on acute and chronic wounds affecting patients with EB. We are doing this trial to determine safety and tolerability of topical CBD cream in a cohort of RDEB patients with chronic wounds (phase II trial), and to evaluate the efficacy and safety of CBD cream in EB with acute and chronic wounds in promoting wound healing, decrease blister formation, pain, itching and improve overall quality of life (phase III trial)

First Posted: November 3, 2020

Condition(s): Epidermolysis Bullosa, Pain, Itch

Intervention(s): AVCN583601 (3% Cannabidiol cream)

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: Elena Pope

Principal Investigator: Elena Pope, Dermatology section head

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

CT.gov Identifier: NCT04613102

The clinical trial "A Prospective Single-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet syndrome and Lennox-Gastaut Syndrome" is a single-group phase III study done in single tertiary referral center in Seoul, Korea. Chief investigator is Dr. Hoon-Chul Kang of Severance Hospital, Yonsei University College of Medicine. Associate investigators are Dr. Heung Dong Kim, Joon Soo Lee, Se Hee Kim, Han Som Choi, Ji Hoon Na, Dong Hwa Yang, and Hee Jung Kang, of Severance Hospital, Yonsei University College of Medicine. The aim of the study is to evaluate the effect of cannabidiol (CBD-OS®) on cognitive functions in patients aged from 2 to 18 years old diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. The duration of study is planned as one year, after patient recruitment of 6 months. The intervention period in each patient is 24 weeks, with 2 weeks of medication titration, stabilization period of 10 weeks, and maintenance period of 12 weeks. The recruitment goal of patient number is 104, considering the study power of 90 percent. Primary outcomes are improvement of cognitive and development and improvement of seizure outcome. Secondary outcomes are improvement in behavior and quality of life. Safety monitoring criteria are adverse event profiles and physician's and caregiver's global assessment. Statistical analysis of outcomes is subject only to the patients who completed the 24-week medication and 2 times of tests before and after treatment of cannabidiol. Evaluation of seizure outcomes would include all patients who completed the 24-week medication and those who dropped out of the study, either by follow-up loss or discontinuation of medication due to incomplete seizure control or adverse effect of the medication. To evaluate safety, the investigators would measure adverse events and dropout rates by percentage. The investigators would analyze overall evaluation of the caregivers and investigator. Serious adverse events would be noted after causality evaluation.

First Posted: November 2, 2020

Condition(s): Dravet Syndrome, Lennox Gastaut Syndrome

Intervention(s): Cannabidiol

Status: Recruiting

Enrollment (expected or actual): 107

Allocation: N/A

Sponsor: Yonsei University

Principal Investigator:

Completion Date (primary or actual): March 2021

CT.gov Identifier: NCT04611438

This study will recruit schizophrenia patients who use cannabis recreationally. Each participant will attend the laboratory on three occasions: an initial visit to check that they are safe to join the study and two days of testing. Participants will be administered, in a randomized order, a pre-treatment with either CBD (1000mg) orally or a matching placebo. On both experiments, participants will then inhale cannabis containing THC. The THC administration will follow a standardised inhalation procedure using a medical-grade vaporizer device. Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences. The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.

First Posted: October 28, 2020

Condition(s): Schizophrenia, Cannabis Use

Intervention(s): Cannabidiol, Placebo, Delta-9-THC

Status: Completed

Enrollment (expected or actual): 36

Allocation: Randomized

Sponsor: King's College London

Principal Investigator: Dr Edward Chesney, Psychiatrist/Clinical Research Fellow/Study Co-ordinator

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

CT.gov Identifier: NCT04605393

Painful symptomatic osteoarthritis (OA) of the knee is a very common disease, especially in older people (lifetime prevalence 9.5%). Current systemic pharmacological treatment options are limited. Many patients presenting with knee osteoarthritis are of an advanced age and suffer from various co-morbidities. The benefit of the available systemic pharmacological treatment options in these patients can be summarized as uncertain. Therefore, the investigation of new symptomatic systemic pharmacological treatment options for knee OA is relevant. Even in patients without known contraindications, the treatment period with non-steroidal anti-inflammatory drugs should be kept short. It follows that the investigation of new potentially anti-inflammatory substances is of interest in symptomatic OA of the knee. Cannabidiol has anti-inflammatory and analgesic properties in animal models. We therefore propose a randomised, double-blind, placebo-controlled clinical trial to investigate the potential efficacy of cannabidiol in painful symptomatic OA of the knee.

First Posted: October 29, 2020

Condition(s): Osteo Arthritis Knee, Pain, Joint

Intervention(s): Cannabidiol Oral Product, Placebo

Status: Completed

Enrollment (expected or actual): 86

Allocation: Randomized

Sponsor: Medical University of Vienna

Principal Investigator: Sibylle Pramhas, MD, Principal Investigator

Completion Date (primary or actual): February 17, 2022

CT.gov Identifier: NCT04607603

The proposed study will assess the drug interaction potential between oral cannabidiol (Epidiolex®) and the carboxylesterase 1 (CES1) substrate methylphenidate (Ritalin®) in 12 healthy research subjects

First Posted: October 26, 2020

Condition(s): Drug Interaction

Intervention(s): di-Methylphenidate plus Cannabidiol, di-Methylphenidate plus Cannabidiol Placebo solution

Status: Completed

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: University of Florida

Principal Investigator:

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

CT.gov Identifier: NCT04603391

The objective of this study is to investigate the bioavailability of Cannabidiol (CBD) and Tetrahydrocannabinol (THC) in an emulsion product against a comparator product. Thirty-two participants will be randomized into a single-center, double-blind, parallel trial. Participants will be dosed in clinic and blood and urine samples will be taken over a 12-hour period. Blood and urine samples will also be collected for 48 hours post-dose at check-in visits. Questionnaires regarding drug effects and cognitive function will also be completed following each blood sampling. Participants who consumed the comparator product will be asked to return to the clinic following a wash-out period of at least 45 days to consume the emulsion product in-clinic and complete questionnaires at the same specified time points over a 12-hour period.

First Posted: October 23, 2020

Condition(s): Healthy, Cannabis

Intervention(s): Cannabis Preparation, Cannabis Preparation

Status: Completed

Enrollment (expected or actual): 32

Allocation: Randomized

Sponsor: New Age Ventures LLC

Principal Investigator:

Completion Date (primary or actual): November 30, 2020

CT.gov Identifier: NCT04601207

Glaucoma is among the leading causes for irreversible blindness worldwide. While lowering intraocular pressure (IOP) remains the mainstay of therapy, there are still some patients who progress despite well-controlled IOP. There is evidence from several studies that ocular blood flow and its regulation is impaired in patients with glaucoma. Tetrahydrocannabinol (THC) has been used in the treatment for glaucoma in some countries for several years due to its IOP lowering effect. In addition, there is also evidence that THC features neuroprotective effects and improves ocular hemodynamics. Dronabinol is a synthetic THC that is legally available in several European countries. It has the advantage that exact dosing of THC is possible in contrast to previously applied administration forms such as smoking. Due to its legal status in the past, data about the effect of THC on ocular blood flow and its regulation are sparse. In a recent study conducted in the investigators laboratory they found that single administration of dronabinol leads to a significant increase in optic nerve head (ONH) blood flow without impairing its autoregulatory capacity.The aim of the present study therefore is to investigate whether single administration of dronabinol alters optic nerve head (ONH) blood flow in patients with open angle glaucoma. In addition, other parameters for ocular blood flow will be measured, in particular retinal blood flow, retinal oxygen saturation and retinal neurovascular coupling. The study will be conducted in a parallel-group, randomized, double-masked, placebo-controlled, cross-over design. Patients will be randomized to either receive 5mg or 10mg dronabinol on one study day. Other studies investigating retinal hemodynamics or IOP after administration of THC also have used similar or slightly higher doses.

First Posted: October 22, 2020

Condition(s): Retinal Blood Flow

Intervention(s): Dronabinol 5 MG, Dronabinol 10 MG, Placebo

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: Medical University of Vienna

Principal Investigator: Doreen Schmidl, Assoc. Prof. PD Doreen Schmidl, MD, PhD,

Completion Date (primary or actual): October 20, 2023

CT.gov Identifier: NCT04596826

Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication, and they report experiencing minimal psychoactive effects. However, there are few well-controlled human laboratory studies assessing cannabis' efficacy for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability. Carefully controlled research is needed. The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory study (N = 20 healthy cannabis users; 10 men, 10 women) will address three important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) Does tolerance develop to repeated, daily smoked cannabis administration on measures of experimental pain and abuse liability; 2) If so, is tolerance reversed during the 7 days of abstinence from active-THC cannabis; 3) Does abrupt abstinence from active cannabis increase experimental pain sensitivity, i.e. hyperalgesia, relative to baseline, and do these effects parallel measures of cannabis withdrawal such as disrupted mood and sleep? Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS). Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.

First Posted: October 22, 2020

Condition(s): Cannabis, Pain, Tolerance, Hyperalgesia

Intervention(s): Cannabis

Status: Suspended

Enrollment (expected or actual): 16

Allocation: N/A

Sponsor: New York State Psychiatric Institute

Principal Investigator: Caroline A. Arout, Ph.D., Assistant Professor of Clinical Neurobiology (in Psychiatry)

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

CT.gov Identifier: NCT04596644