Evidence map›Paper›PMID 42557458›Full record

Trial reportNature medicine2026

Dronabinol for nightmares in post-traumatic stress disorder: a randomized controlled trial.

Stefan Roepke, Nikola Schoofs, Kathlen Priebe, Felix Wuelfing, Kristina Meyer, Astrid Gieselmann, Katharina Stieglbauer, Milagros Galve, Sarah Biedermann, Jürgen Gallinat and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04448808 (Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04448808 phase2completednot on this map

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

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2020 to 2025Enrolled170ConditionsPosttraumatic Stress DisorderArmsBX-1, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Waking from the nightmare of PTSD.Nature medicine · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Stefan RoepkeDepartment of Psychiatry and Neurosciences, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany. stefan.roepke@charite.de.ORCID http://orcid.org/0000-0003-3165-8684
Nikola SchoofsDepartment of Psychiatry and Neurosciences, Campus Charité Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Kathlen PriebeDepartment of Psychiatry and Neurosciences, Campus Charité Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Felix WuelfingDepartment of Psychiatry and Neurosciences, Campus Charité Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0009-0002-4139-0861
Kristina MeyerDepartment of Psychiatry and Psychotherapy, Charité at St. Hedwig Hospital, Charité - Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0003-0232-0211
Astrid GieselmannDepartment of Psychiatry and Neurosciences, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Katharina StieglbauerDepartment of Psychiatry and Neurosciences, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Milagros GalveDepartment of Psychiatry and Neurosciences, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Sarah BiedermannDepartment of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Jürgen GallinatDepartment of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Ingo SchäferDepartment of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Christian SchmahlDepartment of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.
Jenny ZähringerDepartment of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.
Robert RoehleInstitute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0002-8130-6524
Erin D SprünkenInstitute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0002-9422-7788
Tim FriedeDepartment of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.ORCID http://orcid.org/0000-0001-5347-7441
Stefan M GoldDepartment of Psychiatry and Neurosciences, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-5188-4799
Tolou MaslahatiDepartment of Psychiatry and Neurosciences, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Christian OtteDepartment of Psychiatry and Neurosciences, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0002-4051-997X
Stefanie KoglinDepartment of Psychiatry and Neurosciences, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nightmares are a hallmark of post-traumatic stress disorder (PTSD), yet pharmacological treatments remain limited. Here we conducted a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of dronabinol (BX-1; Δ9-tetrahydrocannabinol (THC)) for PTSD-related nightmares. Adults with PTSD and recurrent nightmares were randomly assigned to receive dronabinol (2.5-15 mg) or placebo, once daily before bedtime, for 10 weeks. The primary endpoint was change from baseline to week 10 in the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) B2 item assessing nightmare frequency and intensity. A total of 171 patients underwent randomization (mean age, 37.9 ± 12.8 years; 79.3% female), with 87 assigned to dronabinol and 84 to placebo. At week 10, reduction in CAPS-IV B2 scores was significantly greater with dronabinol than with placebo (between-group difference -1.50; 95% confidence interval -2.28 to -0.71; Cohen's d = 0.65; P < 0.001). Adverse events occurred in 78 patients (89.7%) receiving dronabinol and 64 (77.1%) receiving placebo. Treatment discontinuation due to adverse events occurred in five (5.7%) and six (7.2%) patients, respectively. Serious adverse events occurred in seven patients (8.0%) receiving dronabinol and in none receiving placebo. This trial provides evidence that dronabinol reduces the frequency and intensity of PTSD-related nightmares, although long-term efficacy and safety require further evaluation. ClinicalTrials.gov: NCT04448808 .

Indexed as

DreamsDronabinolStress Disorders, Post-TraumaticAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeDronabinol

Identifiers

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.