Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

Charite University, Berlin, Germany170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

170

Conditions

Posttraumatic Stress Disorder

Interventions

BX-1DRUG

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

PlaceboDRUG

Placebo of BX-1, oral solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Berlin St. Hedwig

Berlin, Germany

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie

Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, Germany

Outcomes

Primary Outcomes

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.

Time frame: 10 weeks

Secondary Outcomes

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.

Time frame: 1, 2, 3, 4,6 and 8 weeks

Change from baseline of the CAPS-5 total score

Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week)

Time frame: 6 and 10 weeks

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)

Time frame: 6 and 10 weeks

Change from baseline of the Montgomery-Åsberg Depression Rating Scale

Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms)

Time frame: 4 and 10 weeks

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

Time frame: during 10 weeks

Weekly mean of change from baseline of the patients sleep onset latency at night

Data from ClinicalTrials.gov

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