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Status:

COMPLETED

Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

Lead Sponsor:

Charite University, Berlin, Germany

Collaborating Sponsors:

Bionorica SE

Conditions:

Posttraumatic Stress Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief 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 exte...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 2 2025

Estimated Enrollment :

170 Patients enrolled

Trial Details

Trial ID

NCT04448808

Start Date

October 1 2020

End Date

January 2 2025

Last Update

August 13 2025

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

Berlin St. Hedwig

Berlin, Germany, 10115

2

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie

Berlin, Germany, 12203

3

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany, 20246

4

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, Germany, 86159