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      Proof of Concept Trial of Dronabinol in Obstructive Sleep Apnea

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          Abstract

          Study Objective: Animal data suggest that Δ 9-TetraHydroCannabinol (Δ 9THC) stabilizes autonomic output during sleep, reduces spontaneous sleep-disordered breathing, and blocks serotonin-induced exacerbation of sleep apnea. On this basis, we examined the safety, tolerability, and efficacy of dronabinol (Δ 9THC), an exogenous Cannabinoid type 1 and type 2 (CB1 and CB2) receptor agonist in patients with Obstructive Sleep Apnea (OSA). Design and Setting: Proof of concept; single-center dose-escalation study of dronabinol. Participants: Seventeen adults with a baseline Apnea Hypopnea Index (AHI) ≥15/h. Baseline polysomnography (PSG) was performed after a 7-day washout of Continuous Positive Airway Pressure treatment. Intervention: Dronabinol was administered after baseline PSG, starting at 2.5 mg once daily. The dose was increased weekly, as tolerated, to 5 mg and finally to 10 mg once daily. Measurements and Results: Repeat PSG assessments were performed on nights 7, 14, and 21 of dronabinol treatment. Change in AHI (ΔAHI, mean ± SD) was significant from baseline to night 21 (−14.1 ± 17.5; p = 0.007). No degradation of sleep architecture or serious adverse events was noted. Conclusion: Dronabinol treatment is safe and well-tolerated in OSA patients at doses of 2.5–10 mg daily and significantly reduces AHI in the short-term. These findings should be confirmed in a larger study in order to identify sub-populations with OSA that may benefit from cannabimimetic pharmacologic therapy.

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          Most cited references 15

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          Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force.

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            EEG arousals: scoring rules and examples: a preliminary report from the Sleep Disorders Atlas Task Force of the American Sleep Disorders Association.

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              Emerging strategies for exploiting cannabinoid receptor agonists as medicines.

               R Pertwee (2009)
              Medicines that activate cannabinoid CB(1) and CB(2) receptor are already in the clinic. These are Cesamet (nabilone), Marinol (dronabinol; Delta(9)-tetrahydrocannabinol) and Sativex (Delta(9)-tetrahydrocannabinol with cannabidiol). The first two of these medicines can be prescribed to reduce chemotherapy-induced nausea and vomiting. Marinol can also be prescribed to stimulate appetite, while Sativex is prescribed for the symptomatic relief of neuropathic pain in adults with multiple sclerosis and as an adjunctive analgesic treatment for adult patients with advanced cancer. One challenge now is to identify additional therapeutic targets for cannabinoid receptor agonists, and a number of potential clinical applications for such agonists are mentioned in this review. A second challenge is to develop strategies that will improve the efficacy and/or the benefit-to-risk ratio of a cannabinoid receptor agonist. This review focuses on five strategies that have the potential to meet either or both of these objectives. These are strategies that involve: (i) targeting cannabinoid receptors located outside the blood-brain barrier; (ii) targeting cannabinoid receptors expressed by a particular tissue; (iii) targeting up-regulated cannabinoid receptors; (iv) targeting cannabinoid CB(2) receptors; or (v) 'multi-targeting'. Preclinical data that justify additional research directed at evaluating the clinical importance of each of these strategies are also discussed.
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                Author and article information

                Journal
                Front Psychiatry
                Front Psychiatry
                Front. Psychiatry
                Frontiers in Psychiatry
                Frontiers Media S.A.
                1664-0640
                22 January 2013
                2013
                : 4
                Affiliations
                [1] 1Department of Medicine, University of Illinois at Chicago Chicago, IL, USA
                [2] 2Department of Pharmacology, University of Illinois at Chicago Chicago, IL, USA
                [3] 3Department of Biobehavioral Health Science, University of Illinois at Chicago Chicago, IL, USA
                Author notes

                Edited by: David Gozal, University of Chicago, USA

                Reviewed by: Patrick J. Strollo, University of Pittsburgh, USA; Josep M. Montserrat, University Hospital Clínic de Barcelona, Spain; Sina A. Gharib, University of Washington, USA; Malcolm Kohler, University Hospital of Zurich, Switzerland

                *Correspondence: David W. Carley, Department of Biobehavioral Health Science, University of Illinois at Chicago, 215W CON MC 802, 845 S Damen Ave, Chicago, IL, 60612, USA. e-mail: dwcarley@ 123456uic.edu

                Bharati Prasad, Miodrag G. Radulovacki and David W. Carley have contributed equally to this work.

                This article was submitted to Frontiers in Sleep Disorders, a specialty of Frontiers in Psychiatry.

                Article
                10.3389/fpsyt.2013.00001
                3550518
                23346060
                87b5efad-96da-44e5-849a-c733a83c5fae
                Copyright © 2013 Prasad, Radulovacki and Carley.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and subject to any copyright notices concerning any third-party graphics etc.

                Page count
                Figures: 1, Tables: 2, Equations: 0, References: 17, Pages: 5, Words: 3571
                Categories
                Psychiatry
                Original Research

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