Table 1 In- and exclusion criteria of the THC-PTSD-trial
Inclusion criteria | Exclusion criteria |
|---|---|
1. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM-5 with a 20 item CAPS-5 total score ≥ 26 | 1. Lifetime cannabis use disorder |
2. At least two nightmares a week, an intensity score ≥ 2, with a CAPS-IV B2 (frequency and intensity for the last week) score ≥ 5 | 2. Current substance/alcohol use disorder (≤ 3 months) |
3. Men and women between 18 and 65 years of age | 3. Acute suicidality |
4. Written informed consent | 4. Psychotic disorder |
5. 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) | 5. Bipolar disorder |
6. The patient is not breastfeeding | 6. Current anorexia nervosa |
7. Women of child-bearing potential must have a negative urine or serum pregnancy test | 7. Current major depressive episodes and a MADRS score > 29 |
8. All participants must use highly effective contraception | 8. Dementia |
9. 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) | 9. Trauma-focused psychotherapy four weeks before the trial |
10. Initiation of sleep medication 4 weeks prior screening or initiation of alpha adrenergic agents 4 weeks prior to screening | |
11. Acute or unstable medical illness | |
12. Epilepsy | |
13. Relevant heart diseases | |
14. Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection | |
15. Current or past malignant illness | |
16. The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons | |
17. Patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial | |
18. The patient is legally detained in an official institution | |
19. The patient does have a known allergy or contraindication against Dronabinol | |
20. The patient does have clinically significant abnormalities in 12-lead ECG | |
21. The patient does have clinically significant laboratory abnormalities | |
22. The patient did participate in other interventional trials during the 3 months before and at the time of this trial |