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Can CBD calm PTSD? new trial seeks answers

NCT ID NCT04550377

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether cannabidiol (CBD), a compound from cannabis, can reduce PTSD symptoms and improve thinking problems in people with PTSD, including those who also have a mild traumatic brain injury. 120 participants will receive either a low or high dose of CBD or a placebo daily for 8 weeks. The main goal is to see if CBD lowers PTSD severity scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cannabidiol (CBD)
What this could lead to
If it works, this could point toward a new treatment option for PTSD symptoms, especially for those who also have a mild traumatic brain injury.
What could go wrong
This is an early Phase 2 trial with only 120 participants, so results may not apply to everyone. CBD may not outperform placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Meets clinical criteria for Posttraumatic Stress Disorder (PTSD) as per Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) * TBI present (for PTSD+TBI subjects only) as per American Congress of Rehabilitation Medicine (ACRM) definition * Mild TBI (for PTSD+TBI subjects only) as per Ohio State University Identification Screener * Able to provide at least 2 locators * Able to provide informed consent * Confirmation that the participant is reliably domiciled * Agreement to abstain from all other cannabinoid use for the duration of the study * Willingness to use contraception if of childbearing potential. Exclusion Criteria: * History of open head injury * TBI within the last 6 months * Moderate or Severe TBI * SUD in the last 12 months other than mild AUD or nicotine use * Use of any cannabinoid containing product within the last 1 month * Positive urine drug screen (Positive for cannabinoids, amphetamine, cocaine, opioids) * Currently prescribed medications with possible CBD-drug interactions * Lifetime history of any psychiatric disorder with psychotic features, bipolar disorder * Exposure to trauma in the last 30 days, including police duty or military service * Psychotherapy for PTSD or other psychiatric conditions initiated within 2 months of screening * Not stable for at least 2 months on psychiatric medication, anticonvulsants, antihypertensive medication, sympathomimetic medication, estrogen replacement therapy, medications associated with neurogenesis, or steroid medication * Active suicide attempt within the past year * Current significant suicidality (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant homicidality. * Neurologic disorder or systemic illness affecting CNS function (apart from TBI) * Major medical illness (i.e. cancer or infectious disease.) * Clinical diagnosis of anemia, advised by physician to avoid blood draws * Significant laboratory abnormalities, significantly impaired hepatic function, abnormalities in complete blood count or metabolic panel * Significant allergic reactions to the drug including cannabinoids or sesame oil * Pregnancy or lactation * Contraindication to MRI * Males and females who plan to conceive a child during or two weeks following the study * Active legal problems likely to result in incarceration within 12 weeks of treatment initiation * Has a high risk of adverse emotional or behavioral reaction (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, and lack of meaningful social support). * Inpatient psychiatric treatment in past 12 months, with the exception of detox and extended ED stays.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • New York University School of Medicine

    RECRUITING

    New York, New York, 10016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.