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Cannabinoid

CBD for PTSD

Q: How does the safety profile of Cannabidiol (CBD) vary when administered as Nantheia ATL5?

<p>The safety of Cannabidiol (<a href="https://www.withpower.com/clinical-trials/cbd">CBD</a>) Nantheia ATL5 is appraised as a 2 on the 1-3 scale, considering that this Phase 2 trial has displayed promising results for security but none for efficacy.</p>

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

Placebo

GWP42003-P 20 mg/kg/Day Dose

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

Find a Location

Who is running the clinical trial?

University of Texas at AustinOTHER

353 Previous Clinical Trials

81,064 Total Patients Enrolled

Ananda Scientific IncUNKNOWN

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,554 Total Patients Enrolled

Media Library

Cannabidiol (CBD) (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05269459 — Phase 2

Post-Traumatic Stress Disorder Research Study Groups: Control Population, Cannabidiol (CBD) as Nantheia ATL5, Placebo

Post-Traumatic Stress Disorder Clinical Trial 2023: Cannabidiol (CBD) Highlights & Side Effects. Trial Name: NCT05269459 — Phase 2

Cannabidiol (CBD) (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269459 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for potential participants in this experiment?

"As listed on clinicaltrials.gov, this medical trial is presently open for patient enrollment. The research was first advertised on December 1st 2022 and updated most recently on March 2nd 2023."

Answered by AI

Is geriatric recruitment available for this clinical trial?

"The study's inclusionary parameters state that candidates must be between 21 to 65 years of age. 40 trials are being conducted for minors and 310 studies are available for seniors beyond the designated threshold."

Answered by AI

How does the safety profile of Cannabidiol (CBD) vary when administered as Nantheia ATL5?

"The safety of Cannabidiol (CBD) Nantheia ATL5 is appraised as a 2 on the 1-3 scale, considering that this Phase 2 trial has displayed promising results for security but none for efficacy."

Answered by AI

How many participants are accepted into this investigatory program?

"Confirmed. Clinicaltrials.gov provides evidence that this medical study is recruiting patients, with the initial posting taking place on December 1st 2022 and a recent update being made on March 2nd 2023. 180 participants are needed from one clinical site."

Answered by AI

Am I permitted to enroll in this medical research endeavor?

"This medical trial is recruiting 180 individuals, aged between 21 and 65, with a current Post Traumatic Stress Disorder. To qualify for this research project participants must provide informed consent to follow the study's protocols; be literate in English; not have used THC more than three times per week; possess valid driving license (with visual acuity of 20/50 or less); drive at least an hour each week in one car 90% of time while having insurance coverage on that vehicle; meet DSM-5 criteria for PTSD diagnosis confirmed by Clinician Administered CAPS-5 score of 27 or higher at study induction and start of CBD observation."

Answered by AI

Who else is applying?

What site did they apply to?

University of Nebraska Medical Center/Nebraska Medicine

University of Nebraska Medical Center

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I have suffered from nightmares where I actually wake up screaming and fighting. I wake up multiple times a night thinking someone is in my house. Cant remember last full night sleep I had. I’ve had a lot of past trauma.

PatientReceived 2+ prior treatments

I’ve been struggling with PTSD for most of my life and only became aware and diagnosed almost a decade ago. I’ve tried CBT and EMDR and I don’t feel like I’m getting the results that allow me to be the person I know I am inside. My PTSD affects my motivation to perform at work, show up for my kids the way I know I want to. I am tired of being held hostage by the events of my past and want to move on so I can be a good role model to my kids and be successful at work providing me and my family the financial security they deserve. I am looking for new solutions that could help get me over the hump and do the work I need to do in therapy so that when I’m trying to be my best self daily, I’m making progress and seeing results. I’m tired of being paralyzed by anxiety and depression and having to use every ounce of strength and determination I have to show up and meet the minimum expectations for being a dad, friend and significant other. I am applying in the hopes of getting back my life.

PatientReceived no prior treatments

Recent research and studies

The Journal of Alternative and Complementary MedicineJournal

Cannabidiol in the Treatment of Post-traumatic Stress Disorder: A Case Series

Elms, Lucas, Scott Shannon, Shannon Hughes, and Nicole Lewis. 2019. “Cannabidiol in the Treatment of Post-traumatic Stress Disorder: A Case Series”. The Journal of Alternative and Complementary Medicine. Mary Ann Liebert Inc. doi:10.1089/acm.2018.0437.

Journal of PsychopharmacologyJournal

Dissociable Effects of Cannabis with and Without Cannabidiol on the Human Brain’s Resting-state Functional Connectivity

Wall, Matthew B, Rebecca Pope, Tom P Freeman, Oliwia S Kowalczyk, Lysia Demetriou, Claire Mokrysz, Chandni Hindocha, et al.. 2019. “Dissociable Effects of Cannabis with and Without Cannabidiol on the Human Brain’s Resting-state Functional Connectivity”. Journal of Psychopharmacology. SAGE Publications. doi:10.1177/0269881119841568.

clinicaltrials.govStudy

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

Matthew Rizzo 2022. "Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05269459.

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