Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

Posttraumatic Stress Disorder Clinical Trial

Official title:

Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol: A Randomized Controlled Study (THC PTSD-trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04448808
• Other study ID #: THC-PTBS
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Stefan Roepke, MD
• Phone: 004930450517545
• Email: stefan.roepke[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• BX-1
BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
• Placebo
Placebo of BX-1, oral solution

Locations

Country	Name	City	State
Germany	Berlin St. Hedwig	Berlin
Germany	Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie	Berlin
Germany	Zentralinstitut für Seelische Gesundheit Mannheim	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Bionorica SE

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and intensity of nightmares	Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. A lower score indicates less frequent and/or intense nightmares.	10 weeks
Secondary	Change from baseline of the frequency and intensity of nightmares	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.	1, 2, 3, 4,6 and 8 weeks
Secondary	Change from baseline of the CAPS-5 total score	Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week)	6 and 10 weeks
Secondary	Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD	Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI A) (PTSD related sleep symptoms)	6 and 10 weeks
Secondary	Change from baseline of the Montgomery-Åsberg Depression Rating Scale	Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms)	4 and 10 weeks
Secondary	Weekly mean of change from baseline of daily total sleep time	Weekly mean of change from baseline of the patients daily total sleep time (in minutes), assessed with sleep diaries	during 10 weeks
Secondary	Weekly mean of change from baseline of the patients sleep onset latency at night	Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries	during 10 weeks
Secondary	Weekly mean of change from baseline of the patients recuperation of night sleep	Weekly mean of change from baseline of the patients recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), assessed with sleep diaries	during 10 weeks
Secondary	Weekly mean of change from baseline of the patients time awake at night	Weekly mean of change from baseline of the patients time awake at night (in minutes), assessed with sleep diaries	during 10 weeks
Secondary	Weekly mean of change from baseline of the patients number of nightmares last night	Weekly mean of change from baseline of the patients number of nightmares last night (0, 1, 3, 4 or more) assessed with sleep diaries	during 10 weeks
Secondary	Weekly mean of change from baseline of the patients intensity of nightmares	Weekly mean of change from baseline of the patients intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries	during 10 weeks
Secondary	Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5	Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5)	6 and 10 weeks
Secondary	Change from baseline of the Borderline Symptom List 23	Change from baseline of the Borderline Symptom List 23 (BSL-23) score	6 and 10 weeks
Secondary	Change from baseline of the Health-Related Quality of Life	Change from baseline of the Health-Related Quality of Life (EQ-5D) score	6 and 10 weeks
Secondary	Overall patients status measured by the Patient Global Impression of Change	Overall patients status measured by the Patient Global Impression of Change (PGIC)	6 and 10 weeks
Secondary	Change from baseline of the Social and Occupational Functioning Assessment Scale	Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS)	6 and 10 weeks
Secondary	Change from baseline of the Pittsburgh Sleep Quality Index	Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)	6 and 10 weeks
Secondary	Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire	Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ)	6 and 10 weeks
Secondary	Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist	Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC)	6 and 10 weeks and Follow- Up Visit 9
Secondary	Responder analysis: proportion of patients showing improvement in nightmares	Responder analysis: proportion of patients showing improvement in nightmares (change from baseline) defined as decrease of CAPS-IV B2 =50% assessed at the end of treatment	10 weeks
Secondary	Remitter analysis: proportion of patients showing full remission of nightmares	Remitter analysis: proportion of patients showing full remission of nightmares defined as CAPS-IV B2 = 0, assessed at the end of treatment	10 weeks