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Cannabidiol for PTSD
Study Summary
This trial will test whether cannabidiol (CBD) can help relieve symptoms of post-traumatic stress disorder (PTSD). Half of the 120 subjects will also have mild traumatic brain injury (TBI). The trial will last 8 weeks, and subjects will be given either 400 or 800 mg of CBD per day, or a placebo. The primary outcome will be change in PTSD symptoms as measured by change in the Clinician-Administered PTSD Scale (CAPS-5) total score.
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- You have a mild traumatic brain injury, as determined by the Ohio State University Identification Screener, and you also have post-traumatic stress disorder.You tried to harm yourself on purpose in the last year.You have major problems with your liver, blood, or metabolism.You had a traumatic brain injury in the last 6 months.You are taking medications that could interact with CBD.You have ever had a mental illness with hallucinations or bipolar disorder.You have experienced a traumatic event, such as being in the military or involved in a police duty, within the past 30 days.You started therapy for PTSD or other mental health conditions within 2 months before the screening.You have a neurological disorder or a serious illness that affects your brain function, except for a previous traumatic brain injury.You have had serious allergic reactions to the drug, including cannabinoids or sesame oil.You cannot have an MRI for medical reasons.You have had a substance use disorder (SUD) in the last year, except for mild alcohol use disorder (AUD) or nicotine use.You have used any products containing cannabinoids in the last month.You have tested positive for drugs like marijuana, amphetamines, cocaine, or opioids in your urine.You have a serious medical condition like cancer or infectious disease.You have been diagnosed with anemia and your doctor has advised against having blood drawn.You have had serious thoughts about harming yourself or others, made serious attempts to harm yourself in the past year, or have been hospitalized for a serious suicide attempt.You have been diagnosed with Posttraumatic Stress Disorder (PTSD) by a clinician using a specific scale called CAPS-5.You have had a previous serious head injury with an open wound.You have a moderate or severe traumatic brain injury.You have a high chance of having strong emotional or behavioral reactions that could make the study difficult for you.You cannot use any other forms of marijuana during the study.If you are able to have children, you agree to use birth control during the study.You have traumatic brain injury (TBI) as defined by the American Congress of Rehabilitation Medicine (ACRM).
- Group 1: Cannabidiol Group 1
- Group 2: Cannabidiol Group 2
- Group 3: Placebo Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this trial open to recruitment at the present?
"The clinical trial's page on Clinicaltrials.gov suggests that it is actively searching for participants, with the initial listing being posted on May 26th 2021 and last updated April 7th 2022."
Are there any prior precedents of research with Cannabidiol Group 1?
"At the moment, 79 clinical studies are examining Cannabidiol Group 1. Of those active trials, 16 have advanced to Phase 3 with 290 sites around the world running tests for this medication; Ribeirao Preto in Sao Paulo being one of them."
What risks does Cannabidiol Group 1 pose to people utilizing it for therapeutic purposes?
"There is some evidence that Cannabidiol Group 1 can be considered safe, thus it has been given a rating of 2. This is because the trial in question falls under Phase 2 which means there is no clinical data yet demonstrating efficacy but certain levels of assurance regarding safety."
Who fulfills the qualifications to become a participant of this trial?
"This research is recruiting 120 individuals between adolescence and old age who have sustained a brain injury. To be considered, hopeful candidates should accept the use of birth control if necessary, demonstrate signs of mild TBI according to Ohio State University's Identification Screener, agree on two contact points for follow-up communication purposes, and abstain from all other cannabinoid products throughout the trial period."
Does this research involve participants aged 18 and above?
"This research is searching for volunteers aged between 18 and 70 years old."
What is the current size of the patient cohort for this investigation?
"Affirmative. As indicated on clinicaltrials.gov, this study is actively searching for eligible participants and was first posted on May 26th 2021 with the latest update occurring April 7th 2022. This medical trial requires 120 subjects to be registered at a single site."
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