Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults

PTSD Clinical Trial

Official title: Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).

Status Recruiting

Clinical Trial Summary

Double-blind placebo controlled study of Cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure(TM) Formulation (Nantheia ATL5(TM)). Subjects complete 3 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 subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).

Clinical Trial Description

This study is a single-site phase II, double-blind, placebo-controlled study of Nantheia ATL5 for symptoms of Post-Traumatic Stress Disorder (PTSD) in adults. Subjects will meet criteria for PTSD using the Clinician-Administered PTSD Scale for DSM-5 (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 and driving (optional) mobility and risk, and sleep dysfunction; neurobiological biomarkers of threat response (optional functional magnetic resonance imaging: fMRI), and serum inflammatory biomarkers (CRP) implicated in PTSD pathophysiology will be assessed. Efficacy and tolerability will be assessed throughout intervention. Serum pregnancy (for subjects of child bearing potential), urine drug screening, CBC, and Comprehensive Metabolic Panel are completed at every on-site visit. Optional consent will be sought from all PTSD and healthy population subjects who agree to complete the fMRI procedures, the driving measures, and providing an additional sample of blood to store for future unspecified research. Baseline characteristics of subjects with PTSD will be evaluated overall and relative to subjects without PTSD (healthy population) during a 3-week baseline period prior to randomization (Nantheia ATL5 or placebo [PBO]). Healthy population subjects will complete the study at end of baseline and subjects 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. ;

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

• NCT number: NCT05269459
• Study type: Interventional
• Source: University of Nebraska
• Contact: Brigette S Vaughan, MSN
• Phone: 402-552-6239
• Email: bvaughan@unmc.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Completion date: August 2027