Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol (NCT04448808) | Clinical Trial Compass
CompletedPhase 2
Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol
Germany170 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score ≥ 26
✓. At least two nightmares a week, an intensity score ≥ 2, with a CAPS-IV B2 (frequency and intensity for the last week) score ≥ 5
✓. Men and women between 18 and 65 years of age
✓. Written informed consent
✓. 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)
✓. The patient is not breastfeeding
✓. Women of child-bearing potential must have a negative urine or serum pregnancy test
✓. All participants must use highly effective contraception
Exclusion criteria
✕. Lifetime cannabis use disorder
✕. Current substance/alcohol use disorder (≤ 3 months);