Scholarlink

<p>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 <i>d</i> = 0.65; <i>P</i> &lt; 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: <a href="https://clinicaltrials.gov/study/NCT04448808">NCT04448808</a>.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 发表日期：

    2026年8月5日

查看全文
  • 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

摘要

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.