Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

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