The efficacy of nabilone, a synthetic cannabinoid, in the treatment of PTSD-associated nightmares: A preliminary randomized, double-blind, placebo-controlled cross-over design study.
Rakesh Jetly, Alexandra Heber, George Fraser, Denis Boisvert
Psychoneuroendocrinology January 2015 DOI: 10.1016/j.psyneuen.2014.11.002 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized double-blind crossover trial Placebo-controlled Peer reviewed |
|---|---|
| Sample size | 10 |
| Population | Canadian male military personnel with PTSD who continued to experience trauma-related nightmares despite standard treatment |
| Intervention | Nabilone |
| Dose | 0.5 mg titrated to effective dose or maximum of 3.0 mg |
| Duration | 7 weeks per treatment period, with a 2-week washout between periods |
| Measures | CAPS Recurring and Distressing Dream scores, Clinical Global Impression of Change (CGI-C), General Well Being Questionnaire (WBQ) |
| Topics | PTSD Dreaming |
| Keywords | Nabilone Nightmares Rct Treatment |
| Key findings | Nabilone reduced nightmare scores on the CAPS Recurring and Distressing Dream item by a mean of 3.6 points versus 1.0 for placebo, and 5 of 10 subjects (50%) were much improved on nabilone versus 1 of 9 (11%) on placebo. The authors conclude nabilone shows promise as a clinically relevant treatment for PTSD-related nightmares in patients who have not responded to traditional therapies, but call for replication in a larger cohort. |
Abstract
Investigate the efficacy of nabilone capsules (NAB) in reducing the frequency and intensity of nightmares in subjects with PTSD. Canadian male military personnel with PTSD, who despite standard treatment continued to experience trauma-related nightmares, received double-blind treatment with 0.5mg NAB or placebo (PBO), and then titrated to the effective dose (nightmare suppression) or reaching a maximum of 3.0mg. Subjects were followed for 7 weeks and then, following a 2-week washout period, were titrated with the other study treatment and followed for an additional 7 weeks. The modified intent-to-treat (mITT) population, which included all treated subjects that met inclusion/exclusion criteria, was analyzed. Ten subjects were included in the mITT population. The mean reduction in nightmares as measured by the CAPS Recurring and Distressing Dream scores were -3.6 ± 2.4 and -1.0 ± 2.1 in the NAB and PBO groups, respectively (p=0.03). Mean global improvement as measured by the Clinical Global Impression of Change (CGI-C) was 1.9 ± 1.1 (i.e. much improved) and 3.2 ± 1.2 (i.e. minimally improved) in the NAB and PBO groups, respectively (p=0.05) Five out of 10 (50%) were much improved on NAB versus 1 out of 9 (11%) on PBO. Results for the General Well Being Questionnaire (WBQ) were 20.8 ± 22 and -0.4 ± 20.6 in the NAB and PBO groups, respectively (p=0.04). The proportion of subjects who experienced a treatment-related occurrence of adverse events was 50% in the NBO group and 60% in the PBO group. No event was severe nor resulted in a drop-out. This study is registered with Health Canada. In this small sample NAB provided significant relief for military personnel with PTSD, indicating that it shows promise as a clinically-relevant treatment for patients with nightmares and a history of non-response to traditional therapies. These findings need to be replicated in a larger cohort. There is a need for further exploration of the effect of nabilone on other symptoms of PTSD such as re-experiencing, hyper vigilance and insomnia.
Comparable studies
Other randomized controlled trials on PTSD, most cited first.
Citations in the library
Cited by 48
- Reviewing the Potential of Psychedelics for the Treatment of PTSD The International Journal of Neuropsychopharmacology March 12, 2020
- Treatment of Posttraumatic Stress Disorder: A State-of-the-art Review. Current Neuropharmacology 2024
- 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
- Diverse therapeutic developments for post-traumatic stress disorder (PTSD) indicate common mechanisms of memory modulation. Pharmacology & Therapeutics November 1, 2022
- Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder Neuropharmacology January 6, 2023
and 43 more in the library
Cites 5
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- Treating nightmares and insomnia in posttraumatic stress disorder: a review of current evidence. Neuropharmacology March 17, 2011
- Best practice guide for the treatment of nightmare disorder in adults. Journal of Clinical Sleep Medicine August 1, 2010
- Dreaming in posttraumatic stress disorder: A critical review of phenomenology, psychophysiology and treatment. Psychotherapy and Psychosomatics 2007