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Posttraumatic Stress DisorderPhase 2NCT04448808

Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

A Phase 2 study testing BX-1 in people with Posttraumatic Stress Disorder, run by Charite University, Berlin, Germany at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
BX-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
4 sitesGermany
Study dates
1 Oct 2020to 2 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Women of child-bearing potential must have a negative urine or serum pregnancy test
  • All participants must use highly effective contraception
  • 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)

Who cannot join

  • Lifetime cannabis use disorder
  • Current substance/alcohol use disorder (≤ 3 months);
  • Acute suicidality;
  • Psychotic disorder;
  • Bipolar disorder;
  • Current anorexia nervosa;
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  • Current major depressive episodes and a MADRS score > 29;
  • Dementia;
  • Trauma-focused psychotherapy four weeks before the trial
  • Initiation of sleep medication 4 weeks prior screening or initiation of alpha adrenergic agents 4 weeks prior to screening
  • Acute or unstable medical illness.
  • Epilepsy
  • Relevant heart diseases
  • Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection
  • Current or past malignant illness
  • The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons
  • Patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
  • The patient is legally detained in an official institution
  • The patient does have a known allergy or contraindication against Dronabinol
  • The patient does have clinically significant abnormalities in 12-lead ECG
  • The patient does have clinically significant laboratory abnormalities
  • The patient did participate in other interventional trials during the 3 months before and at the time of this trial

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Berlin St. Hedwig

    Berlin, 10115

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

    Berlin, 12203

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Zentralinstitut für Seelische Gesundheit Mannheim

    Mannheim, 86159

Other trials in Germany

About this study

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

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.

Being tested
BX-1, Placebo
Keywords
Nightmares, Posttraumatic Stress Disorder, Dronabinol
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04448808
Study groupRoleWhat they receive
BX-1 (dronabinol)ExperimentalBX-1
Receives: Drug: BX-1
PlaceboPlacebo comparatorPlacebo of BX-1
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 weeks

Secondary outcomes (20)

  1. 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.

    Measured: 1, 2, 3, 4,6 and 8 weeks

  2. Change from baseline of the CAPS-5 total score

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

    Measured: 6 and 10 weeks

  3. 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)

    Measured: 6 and 10 weeks

  4. Change from baseline of the Montgomery-Åsberg Depression Rating Scale

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

    Measured: 4 and 10 weeks

  5. 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

    Measured: during 10 weeks

  6. 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

    Measured: during 10 weeks

  7. 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

    Measured: during 10 weeks

  8. 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

    Measured: during 10 weeks

  9. 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

    Measured: during 10 weeks

  10. 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

    Measured: during 10 weeks

  11. 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)

    Measured: 6 and 10 weeks

  12. Change from baseline of the Borderline Symptom List 23

    Change from baseline of the Borderline Symptom List 23 (BSL-23) score

    Measured: 6 and 10 weeks

  13. Change from baseline of the Health-Related Quality of Life

    Change from baseline of the Health-Related Quality of Life (EQ-5D) score

    Measured: 6 and 10 weeks

  14. Overall patients status measured by the Patient Global Impression of Change

    Overall patients status measured by the Patient Global Impression of Change (PGIC)

    Measured: 6 and 10 weeks

  15. Change from baseline of the Social and Occupational Functioning Assessment Scale

    Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS)

    Measured: 6 and 10 weeks

  16. Change from baseline of the Pittsburgh Sleep Quality Index

    Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)

    Measured: 6 and 10 weeks

  17. 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)

    Measured: 6 and 10 weeks

  18. 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)

    Measured: 6 and 10 weeks and Follow- Up Visit 9

  19. 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

    Measured: 10 weeks

  20. 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

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start1 Oct 2020
  3. Primary completion2 Jan 2025
  4. Study completion2 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled study (double-blind)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448808
Sponsor's protocol ID
THC-PTBS
Status last verified
Aug 2025
First submitted
16 Jun 2020
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roepke S, Schoofs N, Priebe K, Wuelfing F, Meyer K, Gieselmann A, Stieglbauer K, Galve M, Biedermann S, Gallinat J, Schafer I, Schmahl C, Zahringer J, Roehle R, Sprunken ED, Friede T, Gold SM, Maslahati T, Otte C, Koglin S. Dronabinol for nightmares in post-traumatic stress disorder: a randomized controlled trial. Nat Med. 2026 Aug 5. doi: 10.1038/s41591-026-04546-9. Online ahead of print.

    PubMed 42557458

  • Roepke S, Schoofs N, Priebe K, Wulfing F, Schmahl C, Rohle R, Zahringer J, Lotter T, Otte C, Koglin S. Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial). BMC Psychiatry. 2023 May 5;23(1):319. doi: 10.1186/s12888-023-04818-5.

    PubMed 37147642

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BX-1 in people with Posttraumatic Stress Disorder, run by Charite University, Berlin, Germany at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and intensity of nightmares (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448808, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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