Systematically Testing the Evidence on Marijuana

The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana [Delta-9-tetrahydracannabinol (THC)] with NLX as a proof of concept towards the possible development of a combined overdose reversal agent with improved tolerability.

First Posted: November 10, 2021

Condition(s): Opioid Overdose

Intervention(s): Naloxone, Marijuana

Status: Recruiting

Enrollment (expected or actual): 32

Allocation: Randomized

Sponsor: New York State Psychiatric Institute

Principal Investigator: Jermaine Jones, Principal Investigator

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

CT.gov Identifier: NCT05114460

This study determines patterns of cannabis use among cancer patients. Information collected in this study may help doctors to understand patient use of cannabis therapy, their knowledge and experiences with this therapy, benefits and risks associated with its use, and whether or to what extent they are discussing it with their health care providers.

First Posted: November 24, 2021

Condition(s): Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention(s): Survey Administration

Status: Recruiting

Enrollment (expected or actual): 1000

Allocation:

Sponsor: Thomas Jefferson University

Principal Investigator:

Completion Date (primary or actual): October 29, 2022

CT.gov Identifier: NCT05132842

Insomnia in perimenopausal women is normal. Studies have shown that insomnia occurs in 75-81% of perimenopausal women and is 2.4 times more common than in premenopausal participants. Western medicine often uses sedative sleeping drugs in the treatment of insomnia in perimenopausal women, which have better effects but have more side effects, and whether they are suitable for long-term application is still controversial. Non-pharmacological traditional therapies in Traditional Chinese Medicine have achieved significant clinical efficacy in the treatment of perimenopausal insomnia patients in recent years. This study aims to explore the efficacy of auricular point seed burying combined with fire dragon pot moxibustion in the treatment of the insomnia symptoms of perimenopausal women.

First Posted: February 10, 2022

Condition(s): Insomnia, Perimenopause

Intervention(s): Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy., Traditional Chinese Medicine auricular acupuncture point buried seeds therapy

Status: Completed

Enrollment (expected or actual): 70

Allocation: Randomized

Sponsor: Weihua Yu

Principal Investigator: Weihua Yu, Director of nursing department

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

CT.gov Identifier: NCT05234814

Medical cannabis (MC) is a standard treatment in Israel to Parkinson's disease (PD) patients suffering from pain. Nevertheless, it is not known about MC effectiveness for other non-motor symptoms of the disease. Our aim is to prospectively observe patients with PD before and after initiation of MC, for non-motor symptoms effect. In specific, relying of data from multiple sclerosis patients and basic science showing cannabinoid receptor 1 (CB1) is abundantly expressed in the sub epithelial layer of the bladder, we will explore the impact of MC on bladder function and urinary symptoms.

First Posted: November 3, 2021

Condition(s): Bladder, Overactive, Parkinson Disease

Intervention(s): Medical Cannabis

Status: Recruiting

Enrollment (expected or actual): 100

Allocation:

Sponsor: Sheba Medical Center

Principal Investigator: Dr. Saar Anis, Principal investigator. Senior Neurologist, Movement Disorders Institute, Sheba Medical Center

Completion Date (primary or actual): August 2023

CT.gov Identifier: NCT05106504

The investigators will conduct a retrospective cohort analysis of a consumer trial conducted by Rae Wellness. The trial took place between October 15, 2020 and December 30, 2020 and involved 1350 U.S. women who used in-home use tests (IHUT) of various Cannabidiol (CBD) products. Participants were randomized to one of 9 groups: 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery, concentration of Tetrahydrocannabinol (THC), and dosage of CBD. Participants were asked to use the product once daily for 60 day and to complete health questionnaires at baseline, 30 days and 60 days.

First Posted: November 4, 2021

Condition(s): Anxiety, Generalized Anxiety Disorder

Intervention(s): Cannabidiol (CBD)- containing consumer products

Status: Completed

Enrollment (expected or actual): 1350

Allocation:

Sponsor: Radicle Science

Principal Investigator:

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

CT.gov Identifier: NCT05108220

This study will obtain preliminary information about whether, and at what dose, cannabidiol (CBD) may help with insomnia in people living with human immunodeficiency virus (HIV). The study will be a 5-week randomized, double-blind placebo-controlled phase II trial using daily oral CBD doses between 50mg and 600mg. Sleep problems will be measured using a wrist-worn device and by self-report. Performance on tests of thinking skills will be compared before and after CBD/placebo treatment. Positive study results will provide support for the use of CBD as a potential treatment for insomnia.

First Posted: October 28, 2021

Condition(s): Sleep Disturbance

Intervention(s): Cannabidiol oral solution, Inert sesame seed oil

Status: Not yet recruiting

Enrollment (expected or actual): 16

Allocation: Randomized

Sponsor: Mariana Cherner, PhD

Principal Investigator: Mariana Cherner, PhD, Professor IR

Completion Date (primary or actual): October 2023

CT.gov Identifier: NCT05097651

With increased availability and use of cannabis by older adults aged ≥ 50 years, a rigorous evaluation of the benefits and risks of cannabis use in these individuals is necessary. Our proposed project will investigate whether older adults who initiate cannabis use after the age of 50 are at an increased risk of fall and what are the underlying mechanisms. We will measure motor and cognitive function in older cannabis users and nonusers and we will use positron emission tomography to determine brain activity and how it is associated with fall risk.

First Posted: October 19, 2021

Condition(s): Cannabis Use

Intervention(s):

Status: Completed

Enrollment (expected or actual): 60

Allocation:

Sponsor: Thorsten Rudroff

Principal Investigator: Thorsten Rudroff, Associate Professor

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

CT.gov Identifier: NCT05084105

The purpose of this study is to test whether or not a medication called nabilone, which is a synthetic (non-natural) medication derived from cannabis, compared to placebo improves symptoms of itch in hemodialysis as measured by visual analog scales.

First Posted: January 6, 2022

Condition(s): End Stage Renal Disease, Pruritus

Intervention(s): Nabilone 0.5 MG Oral Capsule, Placebo Nabilone

Status: Not yet recruiting

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: University of Manitoba

Principal Investigator: David Collister, Adjunct Assistant Professor

Completion Date (primary or actual): October 2023

CT.gov Identifier: NCT05180968

The goal of the study is to evaluate how cannabis use affects memory and thinking skills and response to stress in older adults. The study will also relate cannabis use to Alzheimer's Disease (AD) biomarkers (measurable substances in blood that indicate condition), and test whether sex and hormones play a role in these effects. The study is recruiting adults between the ages of 50 and 80 who use cannabis products on a regular basis. Study participation will last about two weeks.

First Posted: October 11, 2021

Condition(s): Cannabis Use

Intervention(s): Trier Social Stress Task (TSST)

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: N/A

Sponsor: Medical University of South Carolina

Principal Investigator: Andreana Benitez, Assistant Professor

Completion Date (primary or actual): August 2023

CT.gov Identifier: NCT05072795

This pilot randomized controlled trial (RCT) will be conducted to evaluate the acceptability and feasibility of a digital tailored prevention tool (i.e., the Joint Effort mobile application) aimed at supporting university-level students into taking action on their cannabis use. The two main objectives of the proposed study are: To assess the acceptability of the Joint Effort mobile application in terms of uptake, engagement and intervention appreciation. To document the feasibility of the study processes in terms of online recruitment rate, adherence to online data collection methods, and attrition rate.

First Posted: October 29, 2021

Condition(s): Cannabis Use

Intervention(s): Joint Effort, Brief normative feedback and standard information

Status: Completed

Enrollment (expected or actual): 99

Allocation: Randomized

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Principal Investigator:

Completion Date (primary or actual): April 30, 2022

CT.gov Identifier: NCT05099016

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) afflicting over 77,000 Canadians. Unfortunately, the therapeutic arsenal to relieve MS symptoms is limited. It is therefore essential to develop better approaches to treat the symptoms of MS. The use of cannabis for recreational purposes is now legal in Canada. However, for many years, people with Multiple Sclerosis (PwMS) have used cannabis either to relax, to reduce pain and spasticity, or to improve sleep and daily functioning. Currently, there is little scientifically established evidence that cannabis works on these symptoms in people with MS. It is therefore important to carry out studies to better understand the efficacy Δ-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) on MS symptoms . THC is known for its analgesic, neuroprotective and anti-inflammatory properties and CBD seems to have positive effects on anxiety and cognitive abilities (memory, concentration). For this study, investigators hypothesize that administering different doses of THC alone, CBD alone, and THC and CBD combined will result in a significant beneficial effect on spasticity relief compared to placebo.

First Posted: October 25, 2021

Condition(s): Multiple Sclerosis

Intervention(s): Cannabis oil vs placebo

Status: Not yet recruiting

Enrollment (expected or actual): 250

Allocation: Randomized

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Principal Investigator:

Completion Date (primary or actual): March 15, 2024

CT.gov Identifier: NCT05092191

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

First Posted: October 5, 2021

Condition(s): Drug Abuse, Intoxication by Drug, Impairment

Intervention(s): Placebo, THC, CBD, THC + CBD

Status: Not yet recruiting

Enrollment (expected or actual): 22

Allocation: Randomized

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Associate Professor

Completion Date (primary or actual): November 2023

CT.gov Identifier: NCT05067387

This study will investigate whether cannabidiol (CBD), the primary centrally and peripherally active non-intoxicating compound in the cannabis plant, exerts anti-neuroinflammatory effects in patients with chronic low back pain (cLBP) with or without mild-to-moderate depression.

First Posted: October 4, 2021

Condition(s): Back Pain, Depressive Symptoms

Intervention(s): CBD, Placebo

Status: Recruiting

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Massachusetts General Hospital

Principal Investigator: Jodi Gilman, Associate Professor

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

CT.gov Identifier: NCT05066308

The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.

First Posted: September 22, 2021

Condition(s): Back Pain, Neck Pain

Intervention(s): THC/CBD, THC, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 157

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): June 2024

CT.gov Identifier: NCT05052541

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

First Posted: September 16, 2021

Condition(s): Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex

Intervention(s): Cannabidiol

Status: Recruiting

Enrollment (expected or actual): 150

Allocation: N/A

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): August 1, 2027

CT.gov Identifier: NCT05044819

Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain. Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

First Posted: December 28, 2021

Condition(s): Musculoskeletal Pain

Intervention(s): CBD

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: University of Virginia

Principal Investigator: Brent DeGeorge, Assistant Professor of Plastic Surgery

Completion Date (primary or actual): June 2022

CT.gov Identifier: NCT05170451

This proposal's objective is to investigate the effects of topical cannabidiol (CBD) cream on exercise-induced muscle damage, exercise-induced inflammatory markers, and subsequent exercise performance after an exercise-induced damage protocol.

First Posted: September 16, 2021

Condition(s): Muscle Damage

Intervention(s): Cannabidiol Oil, Resistance Exercise

Status: Not yet recruiting

Enrollment (expected or actual): 18

Allocation: N/A

Sponsor: University of New Mexico

Principal Investigator:

Completion Date (primary or actual): May 2023

CT.gov Identifier: NCT05044936

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

First Posted: October 1, 2021

Condition(s): Bipolar Disorder, Cannabis Use, Schizoaffective Disorder, Bipolar Type, Bipolar I Disorder, Bipolar II Disorder, Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Intervention(s): Gabapentin, Placebo

Status: Recruiting

Enrollment (expected or actual): 68

Allocation: Randomized

Sponsor: Medical University of South Carolina

Principal Investigator: James J. Prisciandaro, Associate Professor

Completion Date (primary or actual): June 30, 2026

CT.gov Identifier: NCT05064319

The purpose of this prospective, randomized, double-blind, placebo-controlled trial is to assess the physiological, biochemical, and psychometric impacts of a brand-specific hemp-derived cannabidiol product in a sample of healthy adults.

First Posted: January 28, 2022

Condition(s): Healthy, Safety Issues

Intervention(s): Cannabinol, Placebo

Status: Active, not recruiting

Enrollment (expected or actual): 56

Allocation: Randomized

Sponsor: University of South Carolina

Principal Investigator: Shawn M. Arent, Professor

Completion Date (primary or actual): August 2022

CT.gov Identifier: NCT05212402

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.

First Posted: September 8, 2021

Condition(s): Drug Abuse, Intoxication by Drug, Impairment

Intervention(s): Placebo Cannabis, 20 mg CBD Cannabis, 20 mg CBD + 20 mg THC Cannabis, 20 mg THC Cannabis

Status: Recruiting

Enrollment (expected or actual): 22

Allocation: Randomized

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Associate Professor

Completion Date (primary or actual): November 2023

CT.gov Identifier: NCT05037487

The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.

First Posted: October 13, 2021

Condition(s): Addiction

Intervention(s): CBD Day 1, CBD Day 2, CBD Day 3

Status: Recruiting

Enrollment (expected or actual): 6

Allocation: Non-Randomized

Sponsor: Yale University

Principal Investigator: Joao De Aquino, Principal Investigator

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

CT.gov Identifier: NCT05076370

This single-site study is a pilot, three-armed, double-blinded, placebo-controlled randomized controlled trial (RCT) that will determine the feasibility of a definitive RCT investigating the use of cannabis oil as a treatment for insomnia in individuals with MDD. The study will also determine whether standard THC with higher CBD vs lower CBD has a differential impact on insomnia. The study will also analyze other important objective parameters of sleep including total sleep time and sleep efficiency from actigraphy data. Polysomnography data will also be analyzed. In addition, standardized, validated instruments will be used to collect data on severity of depressive symptoms, cognitive functioning biological rhythm disruption, daytime sleepiness, health-related quality of life (HRQoL), healthcare resource utilization, work productivity and activity impairment, as well as other side effects, in order to better understand the potential impact of the use of cannabis oil on these important health outcomes.

First Posted: September 13, 2021

Condition(s): Insomnia, Depressive Disorder, Major, Sleep Disorder, Depression, Insomnia Chronic

Intervention(s): 25:1 CBD/THC, 5:1 CBD/THC, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: St. Joseph's Healthcare Hamilton

Principal Investigator: Benicio Frey, Professor of Psychiatry and Behavioural Neurosciences, Prinicipal Investigator

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

CT.gov Identifier: NCT05041647

The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.

First Posted: October 4, 2021

Condition(s): Cyclic Vomiting Syndrome

Intervention(s): Droperidol, Haloperidol, Ondansetron 8mg

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: Spectrum Health - Lakeland

Principal Investigator:

Completion Date (primary or actual): June 2023

CT.gov Identifier: NCT05065567

Cannabidiol (CBD) has been approved as a treatment for rare childhood epilepsies and could be an effective treatment for psychotic disorders, anxiety disorders and addictions. It is available as an oral liquid and as standard oral capsules. The bioavailability of oral cannabidiol is poor (only around 5-10% is absorbed), particularly in the fasted state. With food, its absorption is much higher. In one study, a high-fat breakfast increased the maximum plasma concentration by 4-5 times. As a result of this food effect, when prescribing standard oral formulations of CBD, clinicians should provide advice on dosing the drug according to mealtimes, otherwise, there may be an increased risk of side effects or limited effectiveness. One way to reduce the food effect and improve bioavailability is to use lipid encapsulation. In the present study, the investigators will evaluate CBD at the dose that is effective in patients with chronic psychosis (1000mg). The novel formulation will use lipids that are all EU pharmacopoeia approved and have been used in medicinal products before. The study aims to assess whether a novel lipid formulation can increase the bioavailability of oral CBD in the fasting state.

First Posted: September 2, 2021

Condition(s): Absorption; Chemicals

Intervention(s): Cannabidiol standard formulation, Cannabidiol novel formulation

Status: Active, not recruiting

Enrollment (expected or actual): 14

Allocation: Randomized

Sponsor: King's College London

Principal Investigator:

Completion Date (primary or actual): December 31, 2022

CT.gov Identifier: NCT05032807

Generalized anxiety disorder affects about 6.8 million adults in the United States, therefore its treatment is of major public health interest. Cannabidiol (CBD) has shown promise as an effective treatment for anxiety-related symptoms while lacking the severity of adverse effects seen with other medications. Given the wide availability of products containing CBD on the market today, from tinctures to coffee additives, and the undetermined potential for drug-to-drug interactions, medical supervision of CBD intake and formulation-specific clinical research is necessary. Therefore this study aimed to observe the effects of a specific hemp-derived full spectrum CBD formula on anxiety-related symptoms in a group of volunteers. The investigators will examine the self-reported anxiety symptoms in relation to use of a specific CBD formulation (25mg solvent-free full spectrum CBD capsules) in a cohort of adults diagnosed with generalized anxiety disorder. This open-label, cohort study will be conducted at six clinic sites in the United States (including Puerto Rico) from June 2020 through October 2020. The six physicians recruited to participate in the study were each actively prescribing CBD in their practices and were actively caring for patients with anxiety symptoms. Anxiety levels will be measured in enrolled participants diagnosed with generalized anxiety disorder each week for a period of eight weeks using the Generalized Anxiety Disorder 7-Item Scale (GAD7). Participants will also be instructed to take a daily 25mg capsule of CBD. The investigators hypothesize that this formula, when carefully developed and administered by a healthcare professional, will significantly reduce anxiety symptoms.

First Posted: August 27, 2021

Condition(s): Generalized Anxiety Disorder

Intervention(s): Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules

Status: Completed

Enrollment (expected or actual): 30

Allocation:

Sponsor: Formula30A LLC

Principal Investigator:

Completion Date (primary or actual): October 31, 2020

CT.gov Identifier: NCT05023759