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Tests treatment safety and results for PTSD
Official title Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults
ClinicalTrials.gov ID: NCT05269459
What this study is testing
What is Cannabidiol Administered as Nantheia ATL5?
Cannabidiol Administered as Nantheia ATL5 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ptsd.
Also referred to as CBD.
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
- Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65. Healthy volunteers may be eligible.
You may be able to join if
- All Participants
- Ability and willingness to provide informed consent
- Stated willingness to comply with all study procedures and availability for duration of the study
- Aged 21-65 years
- Able to read and communicate in English
You likely can't join if
- All Participants
- Current use of prescribed or commercially available CBD products, including Epidiolex®
- Suicidal ideation (as defined by answer of "yes" to item 4 or 5 on the baseline Columbia Suicide Severity Rating Scale (C-SSRS) or attempt within 6...
- Cognitive impairment in the clinical judgment of the investigator that would impact ability to complete study assessments or confound study results...
- Meets criteria for substance or alcohol use disorder of moderate or greater severity within 6 months prior to study enrollment based on the...
- Self-reported cannabis use on \> 3 days/week starting 4 weeks prior to enrollment
See the full eligibility criteria
- All Participants
- Ability and willingness to provide informed consent
- Stated willingness to comply with all study procedures and availability for duration of the study
- Aged 21-65 years
- Able to read and communicate in English
- Tetrahydrocannabinol (THC) use less than 3 days per week PTSD Participants
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for a current diagnosis of Post-Traumatic Stress Disorder (PTSD) on the Mini-Mental State examination (MMS), with...
- Clinician administered Clinical Assessment of Pragmatics (CAPs) score ≥27 at study enrollment and start of Cannabidiol (CBD) observation
- Stable psychopharmacologic and/or psychotherapeutic intervention for 4 weeks prior to enrollment
- All Participants
- Current use of prescribed or commercially available CBD products, including Epidiolex®
- Suicidal ideation (as defined by answer of "yes" to item 4 or 5 on the baseline Columbia Suicide Severity Rating Scale (C-SSRS) or attempt within 6 months prior to enrollment)
- Cognitive impairment in the clinical judgment of the investigator that would impact ability to complete study assessments or confound study results (e.g., neurodegenerative condition or other)
- Meets criteria for substance or alcohol use disorder of moderate or greater severity within 6 months prior to study enrollment based on the Mini-Mental State examination (MMS); nicotine dependence permitted
- Self-reported cannabis use on \> 3 days/week starting 4 weeks prior to enrollment
- Positive urine drug screen for illicit substances other than cannabis
- Pregnant [confirmed by serum human chorionic gonadotropin (hCG) test], or breastfeeding
- Co-morbid medical conditions or concomitant treatments that may adversely impact ability to participate in the trial in the clinical judgment of the investigator [e.g., significant immunosuppression due to active...
- Treatment with another investigational drug or other intervention within 3 months prior to enrollment
- History of psychosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, or substance induced psychosis), active bipolar disorder, or borderline personality disorder diagnosed by a mental health...
- History of open head injury
- Self-report of exposure to trauma within 30 days prior to enrollment
- Active military service in the 30 days prior to enrollment
- Inpatient psychiatric hospitalization within 6 months prior to enrollment
- Seizure in the last 6 months
- Use of concomitant anti-viral human immunodeficiency virus (HIV) medications (PrEP permitted) Control Participants
- History of diagnosed PTSD
- Pregnant (self-reported) or breastfeeding Participants who consent to functional magnetic resonance imaging (fMRI) procedures
- Claustrophobia, pregnancy, or any condition (e.g., significant hearing difficulties) that would preclude MRI scanning, in the clinical judgment of the investigator
- Presence of metal objects in or on the body (e.g., pacemakers, aneurysm clips, metallic prostheses, bone plates, braces, orthodontic devices, cochlear implants/hearing aids, non-removable piercings/implants or...
- Other confounding medical conditions (e.g., Tourette's or Tic Disorder) that would preclude MRI scanning, in the clinical judgement of the investigator PTSD Participants
- Index trauma before age 18 and no other traumatic experiences which could relate/identify as part of PTSD
- History of allergic reaction or significant adverse events (AE) related to cannabis, CBD, or THC
- Currently involved in events giving rise to PTSD
- Alanine transaminase (ALT)/Aspartate transaminase (AST)/Bilirubin \> 2 x upper limit of normal (ULN) at screening (abnormalities on the comprehensive metabolic panel or complete blood count deemed to be of clinical...
- Refusal to use at least one form of birth control throughout study participation [including, but are not limited to, male or female condoms, diaphragm, or cervical cap (all with or without spermicide) abstinence, or...
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, 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 study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, 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.