BX-1
BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-08-13
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
Placebo of BX-1, oral solution
Eligibility
primary outcomes
Time frame: 10 weeks
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.
secondary outcomes
Time frame: 1, 2, 3, 4,6 and 8 weeks
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: 6 and 10 weeks
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 (PSQI A) (PTSD related sleep symptoms)
Time frame: 4 and 10 weeks
Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms)
Time frame: during 10 weeks
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 (in minutes), assessed with sleep diaries
Time frame: during 10 weeks
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
Time frame: during 10 weeks
Weekly mean of change from baseline of the patients time awake at night (in minutes), assessed with sleep diaries
Publications
Time frame: during 10 weeks
Weekly mean of change from baseline of the patients number of nightmares last night (0, 1, 3, 4 or more) assessed with sleep diaries
Time frame: during 10 weeks
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
Time frame: 6 and 10 weeks
Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5)
Time frame: 6 and 10 weeks
Change from baseline of the Borderline Symptom List 23 (BSL-23) score
Time frame: 6 and 10 weeks
Change from baseline of the Health-Related Quality of Life (EQ-5D) score
Time frame: 6 and 10 weeks
Overall patients status measured by the Patient Global Impression of Change (PGIC)
Time frame: 6 and 10 weeks
Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: 6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 and 10 weeks
Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ)
Time frame: 6 and 10 weeks and Follow- Up Visit 9
Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC)
Time frame: 10 weeks
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
Time frame: 10 weeks
Remitter analysis: proportion of patients showing full remission of nightmares defined as CAPS-IV B2 = 0, assessed at the end of treatment