Posttraumatic Stress Disorder
Conditions
Interventions
Product Name: Dronabinol
Product Code: BX-1
Pharmaceutical Form: Oral solution
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM-5 with a 20 item CAPS-5 total score = 26 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 3. Men and women between 18 and 65 years of age 4. Written informed consent 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) 6. The patient is not breastfeeding 7. Women of child-bearing potential must have a negative urine or serum pregnancy test 8. All participants must use highly effective contraception 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 176 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Lifetime cannabis use disorder 2. Current substance/alcohol use disorder (= 3 months); 3. Acute suicidality; 4. Psychotic disorder; 5. Bipolar disorder; 6. Current anorexia nervosa; 7. Current major depressive episodes and a MADRS score > 29; 8. Dementia; 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to examine whether oral dronabinol (2.5 to 15 mg) reduces nightmares to a greater extent than placebo in patients with posttraumatic stress disorder;Secondary Objective: Secondary objectives of the study are to examine the efficacy of oral dronabinol in reducing other PTSD-specific symptoms, general sleep parameters and depressive symptoms in patients with posttraumatic stress disorder;Primary end point(s): Primary efficacy endpoint: Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0–8, directly after last intervention (10 weeks, Visit 8). A lower score indicates less frequent and/or intense nightmares.;Timepoint(s) of evaluation of this end point: CAPS-IV B2 will be evaluated directly after last intervention (10 weeks) at visit 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline of the frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0–8, at Visit 3 – Visit 7 2. Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week) at Visit 6 and Visit 8 3. Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI-A) (PTSD related sleep symptoms) at Visit 2 – Visit 8 4. Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms) at Visit 6 and Visit 8 5. Weekly mean of change from baseline of the patients daily total sleep time (in minutes), sleep onset latency at night (in minutes), recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), and time awake at night (in minutes), number of nightmares last night (0, 1, 3, 4 or more) and intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries during Visit 2 – Visit 8 6. Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5) at Visit 6 and Visit 8 7. Change from baseline of the Borderline Symptom List 23 (BSL-23) score at Visit 6 and Visit 8 8. Change from baseline of the Health-Related Quality of Life (EQ-5D) score at Visit 6 and Visit 8 9. Overall patients status measured by the Patient Global Impression of Change (PGIC) at Visit 6 and Visit 8 10. Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS) at Visit 6 and Visit 8 11. Change from baseline of the Pittsburgh Sleep Quality Index (PSQI) at Visit 6 and Visit 8 12. Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ) at Visit 6 and Visit 8 13. Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC) at Visit 6, Visit 8, and Visit 9 14. Responder analysis: proportion o | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Charité - Universitätsmedizin Berlin
Outcome results
None listed