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

ConditionPTSD

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age21-65

SponsorUniversity of Nebraska

About this trial

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, and suicide screening is completed throughout.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Cannabidiol Administered as Nantheia ATL5
Drug
Participants will take 4 gel capsules twice daily containing 100mg of Nantheia ATL5.
Placebo
Drug
Participants will take 4 matching gel capsules twice daily containing no active drug.

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: Cannabidiol Administered as Nantheia ATL5 GroupExperimental treatment 1 intervention

Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Post-traumatic Stress Disorder Symptom Rating

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.

Time frame

Baseline and 8 weeks

Secondary outcomes

Post-traumatic Stress Disorder Symptom Symptom Cluster Rating

The cluster scores (symptom domains) are subscales of the CAPS-5 (outcome 1). The CAPS-5 has 20 items, each scored 0-4. The sum of items 1-5 represent cluster B (intrusion symptoms); items 6-7 represent cluster C (avoidance symptoms); items 8-14 represent cluster D (cognitions and mood symptoms); and items 15-20 represent cluster E (arousal and reactivity symptoms). Score ranges are: Cluster B 0-20, Cluster C 0-8, Cluster D 0-28, and Cluster E 0-24. The total of the cluster scores (B+C+D+E) is the total CAPS-5 score. Higher scores indicate greater symptom severity.

Time frame

Baseline and 8 weeks

Post-traumatic Stress Disorder Symptom Rating (Self-reported)

Self-reported rating of post-traumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5). This instrument the 20 items corresponding to the DSM-5 symptom criteria for PTSD. Each item is scored 0 - 4, then symptom scores are totaled. Higher scores indicate greater symptom severity.

Time frame

Baseline and 8 weeks

Clinical Global Impression Post-traumatic Stress Disorder - Severity

Clinical Global Impression Post-traumatic Stress Disorder (PTSD) Symptom Severity (CGI-S) is the assessment by clinicians of the severity of PTSD symptoms based on their experience with adults with PTSD. The CGI-S is scored on a scale of 0 to 7 (0 is "not assessed," 1 is "very much improved and 7 is "very much worse.") Higher scores indicate Higher scores indicate more severe illness.

Time frame

Baseline and 8 weeks

Clinical Global Impression - Improvement

Clinical Global Impression-Improvement (CGI-I) is the assessment by clinicians of the degree of post-traumatic stress disorder (PTSD) symptom improvement based on their experience with the population. It is rated without regard for relatedness to study treatment. The CGI-I is rated on a scale of 0 to 7 (0 is "not assessed," 1 is "very much improved and 7 is"very much worse.") Higher scores indicate worsening of symptoms.

Time frame

Baseline and 8 weeks

Other outcomes

Treatment-Emergent Adverse Events

The number and frequency of spontaneously reported adverse events (any untoward or harmful medical occurrence) from enrollment through study completion will be recorded.

Time frame

8 weeks

Hepatic Function Measured by Serum Alanine Aminotransferase

The clinical measure of hepatic function as measured by serum alanine aminotransferase (ALT) will be determined at baseline and 8 weeks and reported for values of \>3x the upper limit of normal (ULN).

Time frame

Baseline and 8 weeks

Hepatic Function Measured by Serum Aspartate Aminotransferase

The clinical measure of hepatic function as measured by serum aspartate aminotransferase (AST) will be determined at baseline and 8 weeks and reported for values of \>3x the upper limit of normal (ULN).

Time frame

Baseline and 8 weeks

Hepatic Function Measured by Serum Bilirubin

The clinical measure of hepatic function as measured by serum bilirubin will be determined at baseline and 8 weeks and reported for values of \>3x the upper limit of normal (ULN).

Time frame

Baseline and 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

Ananda Scientific

Collaborator

University of Texas at Austin

Collaborator

Source ClinicalTrials.gov

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