Search Results (1674)
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Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations
Alcohol and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. states, and perception of harmfulness falls, CNB use is predicted to rise and it will become increasingly common to publicly encounter persons who recently used the drug. An area of potentially high concern is if ever-greater numbers of CNB users and its legalization will increase the risk of driving while intoxicated from recent CNB use, thereby increasing the risks to public safety. This study aims to examine the combined effects of smoking marijuana and drinking alcohol on simulated driving.
First Posted: April 23, 2021
Condition(s): Marijuana Impairment, Alcohol Impairment
Intervention(s): Low Marijuana, Hash, THC, or Grass, High Marijuana, Hash, THC, or Grass, Placebo, 0.05 BAC Alcohol, 0.08 BAC Alcohol
Status: Recruiting
Enrollment (expected or actual): 12
Allocation: Randomized
Sponsor: Yale University
Principal Investigator: Godfrey Pearlson, Principal Investigator
Completion Date (primary or actual): April 2023
THC + CBD and Memory Study
Memory deficits are one of the most consistently observed cognitive effects of marijuana use. There is evidence that some decrements attributable to the primary psychoactive ingredient, delta-9-tetrahydrocannabinol (THC), may be attenuated by cannabidiol (CBD). This study will help us learn more about the relationship between THC and CBD consumption with memory processes. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure the neurocognitive and behavioral impacts of THC and CBD use.
First Posted: April 22, 2021
Condition(s): Marijuana Use, Cannabis Use, Cannabis Intoxication
Intervention(s): High THC/No CBD Marihuana, High THC/High CBD Marihuana, No THC/No CBD Marihuana
Status: Not yet recruiting
Enrollment (expected or actual): 9
Allocation: Randomized
Sponsor: Hartford Hospital
Principal Investigator: Godfrey Pearlson, Founding Director Olin Neuropsychiatry Research Center; Professor Yale University
Completion Date (primary or actual): June 30, 2022
AnalgeSiC and appEtite-stimulating Effects of caNnabigerol and THC (ASCENT)
This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.
First Posted: April 26, 2021
Condition(s): Pain, Appetite Loss, Abuse, Drug
Intervention(s): Placebo, Low CBG, High CBG, Low THC, High THC
Status: Not yet recruiting
Enrollment (expected or actual): 20
Allocation: Randomized
Sponsor: University of California, Los Angeles
Principal Investigator: Ziva D. Cooper, PhD, Associate Professor
Completion Date (primary or actual): April 1, 2024
Pain, Inflammation, and Cannabis in HIV
This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study the effect of medical cannabis with different THC.CBD content on neuropathic pain, inflammation and adverse events.
First Posted: April 26, 2021
Condition(s): HIV Infections, Neuropathic Pain, Cannabis
Intervention(s):
Status: Not yet recruiting
Enrollment (expected or actual): 100
Allocation:
Sponsor: Montefiore Medical Center
Principal Investigator: Deepika Slawek, Assistant Professor of Medicine
Completion Date (primary or actual): December 12, 2022
Do Adolescents and Adults Differ in Their Acute Response to Cannabis?
The acute effects of cannabis may differ between adolescents and adults. Furthermore, these effects may be tempered by the presence of cannabidiol. This double-blind, placebo-controlled, crossover experiment investigates the acute effects of cannabis (with and without cannabidiol) on subjective effects, behavioural responses and neural functioning in 16-17 year-olds and 26-29 year-olds who regularly use cannabis (0.5-3 days per week).
First Posted: April 20, 2021
Condition(s): Cannabis, Cannabis Intoxication, Cannabis Use, Cannabis Dependence, Marijuana, THC, CBD, Adolescent Development
Intervention(s): Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), Cannabis with THC without CBD, Placebo cannabis
Status: Completed
Enrollment (expected or actual): 48
Allocation: Randomized
Sponsor: University College, London
Principal Investigator:
Completion Date (primary or actual): June 16, 2021
Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation
The purposes of the study are 1) to know the concentrations of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and other cannabinoids in blood, urine, oral fluid and sweat after the experimental administration of a standardized cannabis preparation orally (decoction and oil) and vaporized 2) to evaluate the pharmacological acute effects and tolerability
First Posted: April 12, 2021
Condition(s): Cannabis Use, Healthy Subjects
Intervention(s): Cannabis decoction, Cannabis oil, Vaporized cannabis
Status: Completed
Enrollment (expected or actual): 43
Allocation: Non-Randomized
Sponsor: Germans Trias i Pujol Hospital
Principal Investigator:
Completion Date (primary or actual): December 18, 2019
Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
The Cannabinoide Hyperemesis Syndrom (CHS) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. The diagnosis is linked to clinical criteria only. The physiopathology of CHS is unknown and we observe an increase of cases with this syndrom since 2016 (Schreck et al., 2018).
The aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS.
First Posted: April 8, 2021
Condition(s): Chronic Consumption of Cannabis
Intervention(s): 1 blood sample
Status: Recruiting
Enrollment (expected or actual): 200
Allocation: N/A
Sponsor: Poitiers University Hospital
Principal Investigator:
Completion Date (primary or actual): June 30, 2023
Effects of Cannabidiol (CBD) on the Brain
Cannabidiol (CBD) is a phytocannabinoid that is one of 113 identified cannabinoids in the cannabis plant. It is derived from the hemp plant, and may treat conditions like pain, insomnia, and anxiety. CBD is a critical component of medical marijuana and does not cause the "high" typically associated with cannabis. According to the World Health Organization, CBD has shown no evidence of abuse or dependence potential. However, to the investigator's knowledge, there have not been many acute clinical studies to characterize the effects of CBD in the brain. Despite the rapid influx in CBD readily available to the public, very little is known about such effects. Some studies have shown alterations in resting state connectivity, while others have described changes in specific regions of the brain, or in networks associated with various cognitive functions. For example, CBD has been shown to increase fronto-striatal connectivity and reduce mediotemporal-prefrontal connectivity, suggesting that CBD may affect brain regions involved in salience processing. Unfortunately, few studies have examined CBD in isolation. Additionally, several studies have suggested that CBD may have a neuroprotective effect when it comes to individuals at high risk for psychiatric conditions. In this study, the investigators propose an acute administration, double-blind, placebo-controlled study in which 100% THC-free CBD will be compared to placebo (https://foliumbiosciences.com/). To the investigator's knowledge, the acute effects of this specific product have not been tested. Specifically, the investigators will examine: 1) the neurometabolic and neurophysiological effects of CBD compared to placebo and 2) the behavioral effects of CBD on measures of working memory and response inhibition. Participants will be recruited to take encapsulated, THC-free CBD provided by Folium Biosciences, in which they will have a pre- and post-ingestion scan. Each participant will have a 72-hour washout period after which they will be asked to come back for a placebo scan (however, the order will be counterbalanced so that equal numbers of participants will receive placebo/supplement and supplement/placebo). Individuals will be randomized into the supplementation group, as well as the order.
First Posted: April 5, 2021
Condition(s): CBD, Fear, Inhibition
Intervention(s): Cannabidiol, Placebo
Status: Recruiting
Enrollment (expected or actual): 15
Allocation: Randomized
Sponsor: Auburn University
Principal Investigator: Jennifer L. Robinson, Ph.D., Professor
Completion Date (primary or actual): April 15, 2022
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain (CNCP) is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).
First Posted: April 1, 2021
Condition(s): Opioid Use, Pain, Marijuana Use
Intervention(s): Medical Marijuana, Prescription Opioid Taper Support (POTS)
Status: Recruiting
Enrollment (expected or actual): 250
Allocation: Randomized
Sponsor: Massachusetts General Hospital
Principal Investigator: Jodi Gilman, Assistant Professor
Completion Date (primary or actual): June 30, 2025
Evaluation of the Effectiveness of Cannabidiol in Treating Severe Behavioural Problems in Children and Adolescents With Intellectual Disability
This is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (CBD) with placebo in reducing Severe Behavioral Problems (SBP) at 8 week in children aged 6 - 18 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo.
First Posted: March 30, 2021
Condition(s): Intellectual Disability, Child Behavior Problem
Intervention(s): Cannabidiol Oil, Placebo
Status: Recruiting
Enrollment (expected or actual): 140
Allocation: Randomized
Sponsor: Murdoch Childrens Research Institute
Principal Investigator:
Completion Date (primary or actual): June 2023
Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement
Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention.
Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain
First Posted: March 25, 2021
Condition(s): Acute Radicular Back Pain, Cannabis
Intervention(s): Single-dose of cannabis oil, Control
Status: Recruiting
Enrollment (expected or actual): 200
Allocation: Randomized
Sponsor: Hadassah Medical Organization
Principal Investigator: Elyad Davidson, Director Pain Relief Unit
Completion Date (primary or actual): December 31, 2022
Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment
Aims: To identify the predictors associated with smoking cessation in smokers under treatment for alcohol and/or cannabis treated in drug treatment centers (DTC). Methodology: Mixed methods project with qualitative and quantitative designs (three studies). Study I discussion groups: of clinical professionals of DTC to explore the barriers/facilitators of these smokers in quitting and the interventions carried out. Study II Prospective cohort of smokers in alcohol and/or cannabis treatment that will be followed-up for 12 months. Sample size: difference in incidence (exposed to cessation interventions versus non-exposed = 12 per 100 years), α = 0.05, β = 0.10, losses = 20% (n = 726). Dependent variables: self-reported and verified tobacco consumption abstinence, quit attempts, motivation, and self-efficacy. Independent variables: age, sex, the substance under treatment. Analysis: incidence, relative risk and simple and multiple logistic regression models (odds ratio and confidence interval, CI, 95%) of quitting. Study III discussion groups: with smokers under alcohol and/or cannabis treatment selected according to their typology. Analysis: of thematic content and triangulation qualitative and quantitative results. Expected results: Characterization of variables that influence tobacco cessation, to improve the design of interventions.
First Posted: April 12, 2021
Condition(s): Mental Health Disorder, Substance Abuse Drug, Alcohol Abuse, Cannabis Use, Tobacco Use, Smoking Cessation
Intervention(s):
Status: Recruiting
Enrollment (expected or actual): 1625
Allocation:
Sponsor: Institut Català d'Oncologia
Principal Investigator:
Completion Date (primary or actual): October 2021
NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers
This is a multi-centre, long term, double blind, clinical protocol for NanaBis™ as a monotherapy treatment in participants 18-75 years of age with cancer related pain.
First Posted: March 22, 2021
Condition(s): Cancer Related Pain
Intervention(s): NanaBis™, Oxycodone CR, Placebo Spray, Placebo Tablet, Oxycodone IR
Status: Not yet recruiting
Enrollment (expected or actual): 360
Allocation: Randomized
Sponsor: Medlab Clinical
Principal Investigator:
Completion Date (primary or actual): February 2024
Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury
This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.
First Posted: March 23, 2021
Condition(s): Cannabis, HIV, Inflammation, Cognition, Neuroimaging
Intervention(s): Multimodal, multi-parametric MRI, Immune and cytokine profiling, Neuropsychological testing
Status: Recruiting
Enrollment (expected or actual): 220
Allocation: Non-Randomized
Sponsor: Duke University
Principal Investigator:
Completion Date (primary or actual): May 31, 2025
Gender/Sex & CUD Remission
Adults (ages 18+) who would like to reduce their cannabis use (N=224) will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1-, 2-, and 3-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Salivary samples will be collected (and video observed) daily throughout treatment to analyze for progesterone.
First Posted: July 16, 2021
Condition(s): Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe
Intervention(s): Cognitive Behavioral Therapy (CBT4CBT)
Status: Recruiting
Enrollment (expected or actual): 224
Allocation: Non-Randomized
Sponsor: Medical University of South Carolina
Principal Investigator: Rachel Tomko, PhD, Research Assistant Professor
Completion Date (primary or actual): March 31, 2025
Cannabis Effects on Antiretroviral Therapy Pharmacokinetics and Neurotoxicity
This study will address whether cannabis affects antiretroviral therapy (ART) drug concentrations, mood, and thinking. The project will have two phases. Phase 1 is an observational study, in which 120 people will be assessed to evaluate the effects of chronic cannabis use on ART drug concentrations, mood, and thinking. In Phase 2, the study will administer cannabis (or placebo) to 40 people to examine its acute effects on ART drug concentrations.
First Posted: March 16, 2021
Condition(s): HIV, Cannabis Use
Intervention(s): THC Cannabis, CBD Cannabis, Placebo
Status: Recruiting
Enrollment (expected or actual): 40
Allocation: Randomized
Sponsor: University of California, San Diego
Principal Investigator: Scott Letendre, Professor
Completion Date (primary or actual): January 30, 2025
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
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
Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration
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
Radicle ACES: A Study of Commercially Available CBD Used in the Real-world Setting
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
Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
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
Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
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
Sex Differences in Neural Response to Cannabidiol
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): 10
Allocation: Randomized
Sponsor: Yale University
Principal Investigator:
Completion Date (primary or actual): February 28, 2023
Social Media Intervention - Physical Activity
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
Canadian Registry for the Use of Spectrum Therapeutics Cannabis Products in Subjects With Chronic Pain
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): 407
Allocation:
Sponsor: Canopy Growth Corporation
Principal Investigator:
Completion Date (primary or actual): June 30, 2022
CBD for Chronic Radiculopathy on Chronic Opioid Therapy (COT)
This double-blind, placebo-controlled, proof-of-concept trial is designed to compare effects of oral CBD 600mg to placebo (PCB) in 40 outpatients with chronic spinal radiculopathies (without co-occurring Opioid Use Disorder), maintained on stable moderate to high-dose opioid analgesics for a minimum of 3-months, and motivated to decrease their opioid analgesic maintenance dose. The trial duration will be 6-months (from the point of randomization) and will include a 4-month treatment period (following randomization) of daily CBD 600mg vs placebo, followed by 2 months off of study medication or placebo. Safety and tolerability of CBD will be assessed throughout the trial. The primary efficacy outcome is change in opioid maintenance dose from baseline to end of the treatment period at 16-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: Recruiting
Enrollment (expected or actual): 60
Allocation: Randomized
Sponsor: NYU Langone Health
Principal Investigator:
Completion Date (primary or actual): June 1, 2023
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