← Back to Search

Cannabinoid

CBD for PTSD

Phase 2

Recruiting

Led By Matthew Rizzo, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All Subjects: Male or female, aged 21-65

Be older than 18 years old

Must not have

PTSD Subjects: Index trauma before age 18 and no other traumatic experiences which could relate/identify as part of PTSD

All Subjects: Current use of prescribed or commercially available CBD products, including Epidiolex®

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial studies the effects of CBD on symptoms of PTSD in adults over 8 weeks, using a placebo-controlled, double-blind design. Subjects receive CBD or a placebo for 8 weeks, with assessments of activity and sleep, symptom profile measurements, clinician evaluations, lab tests, and more.

Who is the study for?

Adults aged 21-65 with PTSD, having symptoms for at least a month and a certain score on the CAPS-5 scale. Participants must be stable on current treatments for 4 weeks, drive regularly, and have good vision. Excluded are those using CBD products or other drugs excessively, pregnant or breastfeeding women, people with severe medical conditions or recent suicide attempts.

What is being tested?

The trial tests Cannabidiol (CBD) Nantheia ATL5 against a placebo in adults with PTSD over an 8-week period. Starting at 400mg twice daily after baseline data collection of sleep and activity levels. It includes symptom assessments, lab tests for inflammatory markers, clinician evaluations, and optional driving and brain imaging studies.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of CBD may include tiredness, diarrhea changes in appetite/weight. Since this is a study drug formulation (Nantheia ATL5), there may be additional unknown risks which will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My PTSD is due to trauma experienced before I was 18, with no other related traumas.

Select...

I am currently using prescribed or over-the-counter CBD products.

Select...

I have been diagnosed with a severe mental health condition by a professional.

Select...

I have never had an allergic reaction to cannabis, CBD, or THC.

Select...

I have had a seizure in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CAPS-5

Secondary study objectives

SF-36

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Cannabidiol (CBD) as Nantheia ATL5Experimental Treatment1 Intervention

Cannabidiol (CBD) as Liquid Structure Formulation Nantheia ATL5 400mg BID. Administered in 100mg softgel capsules. Each 100mg softgel contains 10% CBD.

Group II: Control PopulationActive Control1 Intervention

Control group for purposes of baseline data collection

Group III: PlaceboPlacebo Group1 Intervention

Matching placebo

0 / 6Eligibility criteria met