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, Ingo Schäfer, Christian Schmahl, Jenny Zähringer, Robert Roehle, Erin D Sprünken, Tim Friede, Stefan M. Gold, Tolou Maslahati, Christian Otte, Stefanie Koglin
Nature Medicine September 2026 DOI: 10.1038/s41591-026-04546-9 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 171 |
| Population | Adults with PTSD and recurrent nightmares (mean age 37.9 ± 12.8 years; 79.3% female) |
| Intervention | Dronabinol (BX-1; Δ9-tetrahydrocannabinol (THC)) |
| Dose | 2.5-15 mg once daily before bedtime |
| Duration | 10 weeks |
| Measures | Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) B2 item |
| Topics | Dreaming PTSD |
| Registration | NCT04448808 |
| Key findings | Dronabinol reduced the frequency and intensity of PTSD-related nightmares more than placebo over 10 weeks, with a between-group difference of -1.50 on the CAPS-IV B2 item. Serious adverse events occurred in 8.0% of dronabinol patients versus none on placebo, and the authors state that long-term efficacy and safety require further evaluation. |
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 .
Comparable studies
Other randomized controlled trials on PTSD, most cited first.
Citations in the library
Cites 12
- The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial PLoS One March 17, 2021
- Mitigation of post‐traumatic stress symptoms by Cannabis resin: A review of the clinical and neurobiological evidence Drug Testing and Analysis June 26, 2012
- Expectancy in placebo-controlled trials of psychedelics: if so, so what? Psychopharmacology September 5, 2022
- The Endocannabinoid System in PTSD: Molecular Targets for Modulating Fear and Anxiety. Pharmacopsychiatry March 2026
- Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial). BMC Psychiatry May 5, 2023
and 7 more in the library