Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

  • STATUS
    Recruiting
  • End date
    May 14, 2022
  • participants needed
    176
  • sponsor
    Charite University, Berlin, Germany
Updated on 14 May 2021

Summary

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.

Details
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

Eligibility

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

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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.

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

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