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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CAPS-5

Secondary outcome measures

SF-36

Side effects data

From 2015 Phase 3 trial • 120 Patients • NCT02091375

31%

Diarrhoea

31%

Somnolence

26%

Decreased appetite

18%

Fatigue

15%

Vomiting

15%

Pyrexia

11%

Upper respiratory tract infection

11%

Lethargy

Convulsion

Weight decreased

Gamma-glutamyltransferase increased

Irritability

Cough

Transaminases increased

Status epilepticus

Nasopharyngitis

Pneumonia

Oral herpes

Platelet count

Abdominal distension

Abdominal pain

Gastrointestinal haemorrhage

Asthenia

Lower respiratory tract infection

Gamma-glutamyltransferase

Hypophagia

Hypotonia

Myoclonus

Respiratory failure

Epistaxis

Hypovolaemic shock

Aspartate aminotransferase increased

Liver function test abnormal

Headache

100%

80%

60%

40%

20%

Study treatment Arm

GWP42003-P 20 mg/kg/Day Dose

Placebo

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 / 1Eligibility criteria met