Abstract | OBJECTIVE: Investigate the efficacy of nabilone capsules (NAB) in reducing the frequency and intensity of nightmares in subjects with PTSD. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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Authors | Rakesh Jetly, Alexandra Heber, George Fraser, Denis Boisvert |
Journal | Psychoneuroendocrinology
(Psychoneuroendocrinology)
Vol. 51
Pg. 585-8
(Jan 2015)
ISSN: 1873-3360 [Electronic] England |
PMID | 25467221
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014. Published by Elsevier Ltd. |
Chemical References |
- Anti-Anxiety Agents
- nabilone
- Dronabinol
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Topics |
- Adult
- Anti-Anxiety Agents
(pharmacology, therapeutic use)
- Canada
- Cross-Over Studies
- Double-Blind Method
- Dreams
(drug effects, psychology)
- Dronabinol
(analogs & derivatives, pharmacology, therapeutic use)
- Humans
- Male
- Middle Aged
- Military Personnel
- Stress Disorders, Post-Traumatic
(drug therapy, psychology)
- Treatment Outcome
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