Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

  • End date
    May 14, 2022
  • participants needed
  • sponsor
    Charite University, Berlin, Germany
Updated on 14 May 2021


This randomized controlled exploratory phase II trial will test the hypothesis that oral dronabinol improves nightmares (primary outcome) and other PTSD symptoms (secondary outcomes) to a greater extent than placebo over a ten week intervention phase in a parallel group design.

Condition Post-Traumatic Stress Disorder, Post-Traumatic Stress Disorders, Post-Traumatic Stress Disorders, PTSD
Treatment Placebo, BX-1
Clinical Study IdentifierNCT04448808
SponsorCharite University, Berlin, Germany
Last Modified on14 May 2021


Yes No Not Sure

Inclusion Criteria

Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score 26
At least two nightmares a week, an intensity score 2, with a CAPS-IV B2 (frequency and intensity for the last week) score 5
Men and women between 18 and 65 years of age
Written informed consent
The patient has the capacity to give consent (He/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention)
The patient is not breastfeeding
Women of child-bearing potential must have a negative urine or serum pregnancy test
All participants must use highly effective contraception
The patient received stable pharmacological medication for at least 4 weeks prior to study entry (any changes in medication dose or frequency of therapy must be answered with no)

Exclusion Criteria

Lifetime cannabis use disorder
Current substance/alcohol use disorder ( 3 months)
Acute suicidality
Psychotic disorder
Bipolar disorder
Current anorexia nervosa
Current major depressive episodes and a MADRS score > 29
Trauma-focused psychotherapy four weeks before the trial
Initiation of sleep medication 4 weeks prior screening or initiation of alpha adrenergic agents 4 weeks prior to screening
Acute or unstable medical illness
Relevant heart diseases
Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection
Current or past malignant illness
The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons
Patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
The patient is legally detained in an official institution
The patient does have a known allergy or contraindication against Dronabinol
The patient does have clinically significant abnormalities in 12-lead ECG
The patient does have clinically significant laboratory abnormalities
The patient did participate in other interventional trials during the 3 months before and at the time of this trial
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note