Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).
Overview
- Phase
- Phase 2
- Intervention
- Cannabidiol Administered as Nantheia ATL5
- Conditions
- PTSD
- Sponsor
- University of Nebraska
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Post-traumatic Stress Disorder Symptom Rating
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance).
This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI).
Detailed Description
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. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a single-site phase II, double-blind, placebo-controlled study of Nantheia ATL5 to study symptoms of Post-Traumatic Stress Disorder (PTSD) in adults. Participants will meet criteria for PTSD using the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Assessment of Pragmatics (CAPs-5) of ≥ 27. Suicidality is assessed using the Columbia Suicide Severity Rating Scale-Revised (CSSRS-R) at all study visits. Baseline psychopharmacotherapy and/or psychotherapy must be stable (unchanged) for 4 weeks prior to enrollment and should remain unchanged during study treatment. Effects of Nantheia ATL5 on self-reported quality of life (overall and health-related); functional status measurements of personal mobility and risk, and sleep dysfunction; neurobiological biomarkers of threat response (optional functional magnetic resonance imaging: fMRI), and serum inflammatory biomarkers (hs-CRP) implicated in PTSD pathophysiology will be assessed. Efficacy and tolerability will be assessed throughout intervention. Serum pregnancy (for participants of child bearing potential), urine drug screening, complete blood count (CBC), and Comprehensive Metabolic Panel are completed at every on-site visit. Optional consent will be sought from all PTSD and healthy population participants who agree to complete the functional magnetic resonance imaging (fMRI) procedures and providing an additional sample of blood to store for future unspecified research. Baseline characteristics of participants with PTSD will be evaluated overall and relative to participants without PTSD (healthy population) during a 3-week baseline period prior to randomization \[Nantheia ATL5 or placebo (PBO)\]. Healthy population participants will complete the study at end of baseline and participants with PTSD will be randomized 1:1 to Nantheia ATL5 or placebo (PBO). Study drug dose is initiated at 400mg BID and maintained for 8 weeks. Study drug is then withdrawn, and one week later safety measures including laboratory testing, assessment of AE's and CSSRS-R are repeated.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cannabidiol Administered as Nantheia ATL5 Group
Cannabidiol (CBD) as Liquid Structure Formulation Nantheia ATL5 400mg will be administered twice a day in 100mg softgel capsules to CBD Group. Each 100mg softgel contains 10% CBD.
Intervention: Cannabidiol Administered as Nantheia ATL5
Placebo Group
Matching placebo capsules will be administered twice a day to Placebo Group.
Intervention: Placebo
Outcomes
Primary Outcomes
Post-traumatic Stress Disorder Symptom Rating
Time Frame: Baseline and 8 weeks
Structured clinician-administered rating of post-traumatic stress disorder (PTSD) symptoms' severity using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; CAPS-5) Scale. This instrument assesses 20 PTSD symptoms. Each symptom is scored 0 - 4, then symptom scores are totaled. Higher scores indicate greater symptom severity.
Secondary Outcomes
- Post-traumatic Stress Disorder Symptom Symptom Cluster Rating(Baseline and 8 weeks)
- Post-traumatic Stress Disorder Symptom Rating (Self-reported)(Baseline and 8 weeks)
- Clinical Global Impression Post-traumatic Stress Disorder - Severity(Baseline and 8 weeks)
- Clinical Global Impression - Improvement(Baseline and 8 weeks)
- Anxiety Severity Rating(Baseline and 8 weeks)
- Depression Symptoms Rating(Baseline and 8 weeks)
- Global Functioning Disability Questionnaire(Baseline and 8 weeks)
- Quality of Life Health Survey(Baseline and 8 weeks)