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Cannabinoid
Cannabidiol for PTSD
Phase 2
Recruiting
Led By Esther M Blessing, MD PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (post first dose), week 2, week 8.
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.
Who is the study for?
This trial is for men and women with PTSD, some of whom also have mild TBI. Participants must not use other cannabinoids during the study, be able to consent, avoid conceiving children, and meet specific criteria for PTSD or TBI diagnosis. Those with recent severe mental health issues, certain medical conditions or treatments that could interact with CBD are excluded.
What is being tested?
The study tests if cannabidiol (CBD) can help treat PTSD symptoms over an 8-week period. It has three groups: one taking 400 mg of CBD daily, another taking 800 mg daily, and a third receiving a placebo. The main goal is to see how much their PTSD symptoms improve using a specialized scale.
What are the potential side effects?
Potential side effects from CBD may include tiredness, diarrhea, changes in appetite/weight. However, since this is part of what the trial aims to discover more about; participants will be closely monitored for any adverse reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all visits
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in PTSD symptoms
Secondary study objectives
Change in CAPS-5 symptom cluster severity score for Criterion B, Reexperiencing.
Change in CAPS-5 symptom cluster severity score for Criterion C, Avoidance.
Change in CAPS-5 symptom cluster severity score for Criterion D, Negative alterations in cognitions and mood.
+5 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Cannabidiol Group 1Active Control1 Intervention
40 participants will be titrated to a maximum dose of oral cannabidiol 800 mg daily over 2 weeks for a total of 8 weeks treatment.
Group II: Cannabidiol Group 2Active Control1 Intervention
40 participants will be titrated to a maximum dose of oral cannabidiol 400 mg daily over 2 weeks for a total of 8 weeks treatment.
Group III: Placebo GroupPlacebo Group1 Intervention
40 participants will be given a placebo for a total of 8 weeks treatment.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,468 Total Patients Enrolled
Brockman FoundationUNKNOWN
Esther M Blessing, MD PhDPrincipal InvestigatorNYU
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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).
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol Group 1
- Group 2: Cannabidiol Group 2
- Group 3: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04550377 — Phase 2
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