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Marijuana Abuse clinical trials

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NCT ID: NCT04799093 Completed - Impairment Clinical Trials

Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

Start date: February 1, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04783519 Completed - Insomnia Clinical Trials

Research Evaluating Sleep & Trends for Universal Prevention

REST-UP
Start date: August 17, 2021
Phase: N/A
Study type: Interventional

This study is designed to develop an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.

NCT ID: NCT04775030 Recruiting - Clinical trials for Temporomandibular Disorder

Methodology for Developing an Occlusal Appliance With CBD Active Carrier

CBD-OCC-APP
Start date: January 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

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

NCT ID: NCT04737772 Recruiting - Smoking Cessation Clinical Trials

Project CheckUP: A Brief Behavioral Intervention for Quitline Callers Who Use Marijuana (MJ) and Tobacco

Start date: April 13, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04721353 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Reducing Cannabis Overuse With Prazosin

ReCOUP
Start date: November 9, 2020
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04693884 Active, not recruiting - Clinical trials for Cardiovascular Risk Factor

Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

Start date: September 1, 2021
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT04641832 Completed - Concussion, Mild Clinical Trials

The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health

Start date: October 30, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04634136 Completed - Quality of Life Clinical Trials

Full-spectrum Medical Cannabis for Treatment of Spasticity in Patients With Severe Forms of Cerebral Palsy

HemPhar
Start date: October 15, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04627922 Recruiting - Clinical trials for Tobacco Use Disorder

N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use

NAC_CUD-TUD
Start date: August 25, 2021
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04601207 Completed - Healthy Clinical Trials

A Study Investigating the Bioavailability of CBD and THC in an Emulsion Product in a Healthy Population

Start date: June 19, 2020
Phase: Phase 1
Study type: Interventional

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.