Medical Cannabis Clinical Research Proposal Paper

Medical Cannabis Clinical Research Proposal Paper

Medical Cannabis Clinical Research Proposal Paper

Abstract

            The marijuana plant contains several related compounds with the most two abundant being CBD (cannabidiol) and ∆9 THC (tetrahydrocannabinol). CBD is considered non-psychoactive with potential beneficial health effects (Freeman et al., 2019). The objective of this study is to determine whether CBD-based therapy can be used to treat THC intoxication. A meta-analysis study design will be utilized in conducting a systematic review of relevant literature sources drawn from medical journals located on online websites and medical databases. The selection of articles and data collection will be based on the following research question:

“Can CBD be used to treat patients suffering from THC intoxication, which has become more prevalent in emergency rooms across the United States”

Collected data will be analyzed by use of a t-test to draw a conclusion based on whether the findings support the study hypothesis.

BUY A CUSTOM PAPER HERE

Background

            Most recent studies are focusing on developing adequate evidence supporting the medicinal use of cannabidiol (CBD) and its positive benefits as a non-intoxicating cannabinoid. Significant pharmacological research on the medical use of CBD took place in the 1970s and has intensified ever since with discoveries in the management of different psychiatric disorders (Drennan et al., 2021). For instance, several preclinical and clinical research led to the approval of Epidio-lex®, by the FDA as purified CBD medicine for the management of infantile refractory epileptic. The continuous use of medicinal CBD in addition to legalized recreational cannabis has led to increased incidences of THC intoxication in emergency rooms across the United States. Limited studies have however focused on the development of evidence on the use of the management of THC intoxication, which has led to the development of this research project.

Literature Search

            For a comprehensive understanding of the background of this study, we reviewed several literature sources located in medical databases. The search terms that were utilized include “CBD,” “THC intoxication,” “CBD-based therapy,” “psychiatric side effects,” and “psychoactive chemicals in cannabis.” Studies conducted by Solowij et al. (2019) and Pennypacker & Romero‐Sandoval, (2020) reveal the great effectiveness of CBD in reducing the impact of THC intoxication, with a desirable safety profile. However, a study conducted by Arkell et al., (2019) still claim that CBD does not have the capacity for THC-induced cognitive impairments.

Study Objectives

            The main aim of this study is to determine the effectiveness of CBD-based therapy in managing THC intoxication in the emergency room of hospitals in the United States. The study also aims at evaluating the side effects associated with the use of CBD and how they can be managed (Freeman et al., 2019).

 Study Design and Methodology

Study design and rationale

            A meta-analysis study design will be utilized for this project given that this method systematically combines pertinent quantitative and qualitative study data from several selected research articles to come up with a single conclusion with greater statistical power (Vallée et al., 2020). This method also possesses a confirmatory data analysis method which promotes a more accurate estimate of the outcome.

Inclusion criteria

            For articles to be eligible for review in this study, the following inclusion criteria will be utilized: articles published in English, within the last 5 years; clinical research articles which compare the use of CBD in treating THC intoxication to other previously used approaches; and clinical studies whose study findings have been published (Solowij et al., 2019).

Exclusion criteria

For articles to be disqualified from inclusion in this study, the following factors will be observed: studies that used an observational design; studies that were published more than 5 years ago; studies published in other languages other than English; and finally, clinical trial with unpublished results (Pennypacker & Romero‐Sandoval, 2020).

Anticipated/estimated number of subjects

            Given that only a few researchers have focused on the use of CBD-based therapy in the management of THC intoxication, this study will most probably review only 10 valid and reliable literature sources which meet the inclusion/exclusion criteria (Arkell et al., 2019). The collected information must also be up to date, which also limits the number of potential studies given the few publications posted within the last 5 years that can help answer the study research question.

Methodology

            A systematic review and meta-analysis will be utilized to obtain information supporting the study hypothesis on statistical significance and relevance. Several scientific and medical databases such as PubMed, EMBASE, PubMed Central (PMC), and Cochrane among others, will be utilized to locate potential articles for review. Search terms that will be used include “CBD,” “THC intoxication,” “CBD-based therapy,” “psychiatric side effects,” and “psychoactive chemicals in cannabis” (Pennypacker et al., 2021). Only studies that meet the inclusion/exclusion criteria will be reviewed to collect the required information necessary to answer the research question. The collected data will be analyzed using a t-test to draw a statistically significant conclusion.

Data collection procedure

            Once the studies for review have been selected, the data collection team will describe each study, and construct tables and figures to represent the findings of each study concerning the outcome variables for this research project (Vallée et al., 2020). Reporting guidelines for systemic review such as the PRISMA statement will be utilized to ensure the incorporation of only relevant elements.

Data protection procedure

            Data protection remains a crucial issue in clinical research. For this project data protection and confidentiality, protocols will be documented before the project begins and will include aspects such as loss, tampering, and theft of the data (Vallée et al., 2020). The access control strategy will be utilized to restrict only authorized personnel to access the collected data.

Ethics and Consent Procedures

Key Ethical Concerns and Vulnerabilities

The study project utilizes a simple research design, a meta-analysis that involves a systematic review of literature sources, hence avoiding the direct involvement of human participants in the study process. As such, this study does not need to be reviewed or approved by the institutional review board (IRB). Nevertheless, the outcome of this project is expected to promote the quality and safety of patient care. As such, thecal issues relating to the study outcome and how they are communicated may arise. Some of these issues include plagiarism, research misconduct, and the presentation of unreliable and inaccurate data (Drennan et al., 2021). Consequently, the study involves a review of previous research articles which may involve socially and economically vulnerable participants given that most of these people have an increased incidence of cannabis use, hence forming the larger part of the target audience. However, it is important to observe legal and ethical principles to avoid ensure the successful implementation of the project and presentation of the results.

Protecting Participants and Health Information

            To protect participant and their health information, it will be necessary to come up with protocols that ensure that the rights of participants are upheld at the highest standard. Consequently, as the investigator, I will ensure that I don’t use the actual names of the participants, and also make sure that I do not include information that can disclose the participant being described in the collected data (Pennypacker et al., 2021). Consequently, in protecting the health information of participants, I will control access to the collected data to only authorized personnel.

Conclusion

            The EBP proposal aims at determining the effectiveness of CBD-based therapy in reducing the impact of THC intoxication among patients in the emergency room. A systematic review and meta-analysis study design will be utilized to collect relevant information to confirm the study hypothesis. Given that the outcome of the study is crucial in promoting the quality of care provided, ethical measures will be observed to promote the presentation of accurate, valid, and reliable results.

References

Arkell, T. R., Lintzeris, N., Kevin, R. C., Ramaekers, J. G., Vandrey, R., Irwin, C., … & McGregor, I. S. (2019). Cannabidiol (CBD) content in vaporized cannabis does not prevent tetrahydrocannabinol (THC)-induced impairment of driving and cognition. Psychopharmacology, 236(9), 2713-2724. https://doi.org/10.1007/s00213-019-05246-8

Drennan, M. L., Karoly, H. C., Bryan, A. D., Hutchison, K. E., & Bidwell, L. C. (2021). Acute objective and subjective intoxication effects of legal-market high potency THC-dominant versus CBD-dominant cannabis concentrates. Scientific reports, 11(1), 1-10. https://doi.org/10.1038/s41598-021-01128-2

Freeman, A. M., Petrilli, K., Lees, R., Hindocha, C., Mokrysz, C., Curran, H. V., … & Freeman, T. P. (2019). How does cannabidiol (CBD) influence the acute effects of delta-9-tetrahydrocannabinol (THC) in humans? A systematic review. Neuroscience & Biobehavioral Reviews, 107, 696-712. https://doi.org/10.1016/j.neubiorev.2019.09.036

Pennypacker, S. D., & Romero‐Sandoval, E. A. (2020). CBD and THC: Do They Complement Each Other Like Yin and Yang?. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 40(11), 1152-1165. https://doi.org/10.1002/phar.2469

Pennypacker, S., Cunnane, K., & Romero, E. A. (2021). CBD and THC: Does the market reflect therapeutic dosing?. The Journal of Pain, 22(5), 587-588. https://doi.org/10.1016/j.jpain.2021.03.042

Solowij, N., Broyd, S., Greenwood, L. M., van Hell, H., Martelozzo, D., Rueb, K., … & Croft, R. (2019). A randomized controlled trial of vaporized Δ9-tetrahydrocannabinol and cannabidiol alone and in combination in frequent and infrequent cannabis users: acute intoxication effects. European archives of psychiatry and clinical neuroscience, 269(1), 17-35. https://doi.org/10.1007/s00406-019-00978-2

Vallée, A., Blacher, J., Cariou, A., & Sorbets, E. (2020). Blended learning compared to traditional learning in medical education: systematic review and meta-analysis. Journal of medical Internet research, 22(8), e16504. doi:10.2196/16504

ORDER A PLAGIARISM-FREE PAPER HERE

Submit your completed Medical Cannabis Clinical Research Proposal. Use the Research Proposal Template provided earlier in the course as a guide to help you understand what type of information is to be included with each section. Your completed proposal should contain the following sections clearly labeled and defined.
Research Question/PICO question
Abstract
Background
Background
Literature Search
Study Objectives
Study design and Methodology
Study design and rationale
Inclusion criteria
Exclusion criteria
Anticipated/estimated number of subjects
Methodology
Data collection procedure
Data protection procedure
Ethics and consent procedures
Key ethical concerns and vulnerabilities in your study design and population
Steps you will take as the investigator to protect participants and health information
Citations and Bibliography
Each of the above 6 sections will be graded on a rubric which will be combined for a complete grade for the project. The rubric will be visible in the Module resources and Helpful Resources tab for you to review prior to submission.
Note that we do not have a completed biostatistical or statistical analysis of your project, which was outside of the scope of this course and requires formal statistician support. This component will require further analysis and development with an advisor if students wish to pursue real world application of their study proposal.

Section	Acceptable	Needs Improvement	Unacceptable
Title (10%)	(100%) Clearly worded title including study topic, design, and investigator (student) name	(50%) Unclear title, does not include all elements (missing study topic, design, or investigator name)	(0%) No clear title Study topic, design, and investigator name not stated. Section missing.
Abstract (18%)	(100%) Clearly states research question/PICO question, provides summary of study background and significance, study population, design, and data collection method.	(50%) Research question/PICO question is missing or unclear. Missing some elements from abstract	(0%) Abstract is missing or contains none of the required elements (No research question, no summary of background, significance, study population, design, or data collection)
Background (18%)	(100%) Provides well supported discussion of the clinical problem or question, population affected, and need for this research topic. Provides Literature review with search terms and detailed summary of findings Study objectives are clearly stated.	(50%) Provides some, but not detailed, discussion of clinical problem, population affected, or need for research topic. Some elements are missing. Literature search is not clear, is missing search terms, or is lacking a detailed summary. Study objectives are unclear.	(0%) Background section is missing or minimal. Literature search is missing. Study objectives missing.
Study Design and Methodology (18%)	(100%) Clearly stated study design and rationale, inclusion/exclusion criteria, estimated number of subjects, methodology, data collection procedure, and data protection procedures.	(50%) Unclear study design. Contains some but not all of the required elements. Unclear methodology, data collection and protection strategy	(0%) Study design and methodology section is missing or contains none of the required information.

 

Ethics and consent procedures (18%)	(100%) Identifies and discusses key ethical concerns and vulnerabilities in population and study design. Identifies and discusses a clear strategy to protect study subjects and personal health information.	(50%) Partially or minimally discusses ethical concerns and vulnerabilities in population and study design. Partially or minimally discusses a strategy to protect study subjects and personal health information.	(0%) Ethics and consent discussion section is missing or contains none of the required information.
Citations and Bibliography (18%)	(100%) Pertinent statements are appropriately cited with corresponding references. Bibliography items are clearly formatted and numbered. Either AMA or APA format is acceptable	(50%) Citations are inconsistent. Bibliography is missing elements or lacks clear format.	(0%) Citations are missing. Bibliography is missing or unformatted.

Total possible points: 60