Clinical trial NCT04448808: Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol
Official title: Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol: A Randomized Controlled Study (THC PTSD-trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Keywords: Nightmares
Posttraumatic Stress Disorder
Dronabinol
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Bionorica SE
First posted: 2020-06-26
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study (double-blind)
Primary purpose: TREATMENT

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 extent than placebo over a ten week intervention phase in a parallel group design.


Eligibility 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)

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

Primary outcomes:
measure: Frequency and intensity of nightmares
timeFrame: 10 weeks
Secondary outcomes:
measure: Change from baseline of the frequency and intensity of nightmares
timeFrame: 1, 2, 3, 4,6 and 8 weeks
measure: Change from baseline of the CAPS-5 total score
timeFrame: 6 and 10 weeks
measure: Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD
timeFrame: 6 and 10 weeks
measure: Change from baseline of the Montgomery-Åsberg Depression Rating Scale
timeFrame: 4 and 10 weeks
measure: Weekly mean of change from baseline of daily total sleep time
timeFrame: during 10 weeks
measure: Weekly mean of change from baseline of the patients sleep onset latency at night
timeFrame: during 10 weeks
measure: Weekly mean of change from baseline of the patients recuperation of night sleep
timeFrame: during 10 weeks
measure: Weekly mean of change from baseline of the patients time awake at night
timeFrame: during 10 weeks
measure: Weekly mean of change from baseline of the patients number of nightmares last night
timeFrame: during 10 weeks
measure: Weekly mean of change from baseline of the patients intensity of nightmares
timeFrame: during 10 weeks
measure: Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5
timeFrame: 6 and 10 weeks
measure: Change from baseline of the Borderline Symptom List 23
timeFrame: 6 and 10 weeks
measure: Change from baseline of the Health-Related Quality of Life
timeFrame: 6 and 10 weeks
measure: Overall patients status measured by the Patient Global Impression of Change
timeFrame: 6 and 10 weeks
measure: Change from baseline of the Social and Occupational Functioning Assessment Scale
timeFrame: 6 and 10 weeks
measure: Change from baseline of the Pittsburgh Sleep Quality Index
timeFrame: 6 and 10 weeks
measure: Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire
timeFrame: 6 and 10 weeks
measure: Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist
timeFrame: 6 and 10 weeks and Follow- Up Visit 9
measure: Responder analysis: proportion of patients showing improvement in nightmares
timeFrame: 10 weeks
measure: Remitter analysis: proportion of patients showing full remission of nightmares
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Berlin St. Hedwig
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit Mannheim
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan Roepke, MD
role: PRINCIPAL_INVESTIGATOR
References: