BridgeMD
New treatment option for Post Traumatic Stress Disorder
Official title Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI
ClinicalTrials.gov ID: NCT04550377
What this study is testing
What is Cannabidiol?
Cannabidiol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for post traumatic stress disorder.
Also referred to as NANTHEIA™, A1002N5S.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This will be a randomized placebo controlled study to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic stress disorder (PTSD). Subjects, 120 in total, will be males and females with PTSD, half of which will have comorbid mild traumatic brain injury (TBI).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Meets clinical criteria for Posttraumatic Stress Disorder (PTSD) as per Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
- TBI present (for PTSD+TBI people only) as per American Congress of Rehabilitation Medicine (ACRM) definition
- Mild TBI (for PTSD+TBI people only) as per Ohio State University Identification Screener
- Able to provide at least 2 locators
- Able to provide informed consent
You likely can't join if
- History of open head injury
- TBI within the last 6 months
- Moderate or Severe TBI
- SUD in the last 12 months other than mild AUD or nicotine use
- Use of any cannabinoid containing product within the last 1 month
- Positive urine drug screen (Positive for cannabinoids, amphetamine, cocaine, opioids)
See the full eligibility criteria
- Meets clinical criteria for Posttraumatic Stress Disorder (PTSD) as per Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
- TBI present (for PTSD+TBI people only) as per American Congress of Rehabilitation Medicine (ACRM) definition
- Mild TBI (for PTSD+TBI people only) as per Ohio State University Identification Screener
- Able to provide at least 2 locators
- Able to provide informed consent
- Confirmation that the participant is reliably domiciled
- Agreement to abstain from all other cannabinoid use for the duration of the study
- Willingness to use contraception if of childbearing potential.
- History of open head injury
- TBI within the last 6 months
- Moderate or Severe TBI
- SUD in the last 12 months other than mild AUD or nicotine use
- Use of any cannabinoid containing product within the last 1 month
- Positive urine drug screen (Positive for cannabinoids, amphetamine, cocaine, opioids)
- Currently prescribed medications with possible CBD-drug interactions
- Lifetime history of any psychiatric disorder with psychotic features, bipolar disorder
- Exposure to trauma in the last 30 days, including police duty or military service
- Psychotherapy for PTSD or other psychiatric conditions initiated within 2 months of screening
- Not stable for at least 2 months on psychiatric medication, anticonvulsants, antihypertensive medication, sympathomimetic medication, estrogen replacement therapy, medications associated with neurogenesis, or steroid...
- Active suicide attempt within the past year
- Current significant suicidality (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant...
- Neurologic disorder or systemic illness affecting CNS function (apart from TBI)
- Major medical illness (i.e. cancer or infectious disease.)
- Clinical diagnosis of anemia, advised by physician to avoid blood draws
- Significant laboratory abnormalities, significantly impaired hepatic function, abnormalities in complete blood count or metabolic panel
- Significant allergic reactions to the drug including cannabinoids or sesame oil
- Pregnancy or lactation
- Contraindication to MRI
- Males and females who plan to conceive a child during or two weeks following the study
- Active legal problems likely to result in incarceration within 12 weeks of treatment initiation
- Has a high risk of adverse emotional or behavioral reaction (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, and lack of meaningful social support).
- Inpatient psychiatric treatment in past 12 months, with the exception of detox and extended ED stays.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.