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Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea.

ABSTRACT: Study Objectives:There remains an important and unmet need for fully effective and acceptable treatments in obstructive sleep apnea (OSA). At present, there are no approved drug treatments. Dronabinol has shown promise for OSA pharmacotherapy in a small dose-escalation pilot study. Here, we present initial findings of the Phase II PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial, a fully blinded parallel groups, placebo-controlled randomized trial of dronabinol in people with moderate or severe OSA. Methods:By random assignment, 73 adults with moderate or severe OSA received either placebo (N = 25), 2.5 mg dronabinol (N = 21), or 10 mg dronabinol (N = 27) daily, 1 hour before bedtime for up to 6 weeks. Results:At baseline, overall apnea-hypopnea index (AHI) was 25.9 ± 11.3, Epworth Sleepiness Scale (ESS) score was 11.45 ± 3.8, maintenance of wakefulness test (MWT) mean latency was 19.2 ± 11.8 minutes, body mass index was 33.4 ± 5.4 kg/m2, and age was 53.6 ± 9.0 years. The number and severity of adverse events, and treatment adherence (0.3 ± 0.6 missed doses/week) were equivalent among all treatment groups. Participants receiving 10 mg/day of dronabinol expressed the highest overall satisfaction with treatment (p = .04). In comparison to placebo, dronabinol dose-dependently reduced AHI by 10.7 ± 4.4 (p = .02) and 12.9 ± 4.3 (p = .003) events/hour at doses of 2.5 and 10 mg/day, respectively. Dronabinol at 10 mg/day reduced ESS score by -3.8 ± 0.8 points from baseline (p < .0001) and by -2.3 ± 1.2 points in comparison to placebo (p = .05). MWT sleep latencies, gross sleep architecture, and overnight oxygenation parameters were unchanged from baseline in any treatment group. Conclusions:These findings support the therapeutic potential of cannabinoids in people with OSA. In comparison to placebo, dronabinol was associated with lower AHI, improved self-reported sleepiness, and greater overall treatment satisfaction. Larger scale clinical trials will be necessary to clarify the best potential approach(es) to cannabinoid therapy in OSA.

SUBMITTER: Carley DW

PROVIDER: S-EPMC5806568 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea.

Carley David W DW Prasad Bharati B Reid Kathryn J KJ Malkani Roneil R Attarian Hryar H Abbott Sabra M SM Vern Boris B Xie Hui H Yuan Chengbo C Zee Phyllis C PC

Sleep 20180101 1

<h4>Study objectives</h4>There remains an important and unmet need for fully effective and acceptable treatments in obstructive sleep apnea (OSA). At present, there are no approved drug treatments. Dronabinol has shown promise for OSA pharmacotherapy in a small dose-escalation pilot study. Here, we present initial findings of the Phase II PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial, a fully blinded parallel groups, placebo-controlled randomized trial of dronabinol in peop ...[more]

PMID: 29121334

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Project description:BackgroundIn recent years, obstructive sleep apnea (OSA) has been increasingly recognized as a significant health concern. No previous studies assessed the effect of recommended treatment modalities of patients with OSA on the temporomandibular joint (TMJ). The current study aimed to evaluate the effect of different treatment modalities of OSA, such as continuous positive airway pressure (CPAP), mandibular advancement device (MAD), and oral myofunctional therapy (OMT) on subjective symptoms, clinical, and radiographic signs of temporomandibular disorders.Patients & methodsThis hospital-based prospective randomized controlled clinical trial study was approved by the institutional review board and formal patient consent, 39 OSA patients, ranging in age from 19 to 56 after confirmation with full night Polysomnography (PSG) with healthy TMJ confirmed clinically and radiographically with magnetic resonance imaging (MRI) were randomly allocated into three treatment groups. Group 1: 13 patients were managed with CPAP after titration, group 2: 13 patients were managed with digitally fabricated MAD, and group 3: 13 patients were managed with OMT. The following parameters were evaluated before and 3 months after the intervention. Pain using a visual analogue scale (VAS), maximum inter-incisal opening (MIO), lateral movements, and clicking sound of TMJ. MRI was done before and 3 months after the intervention.ResultsOut of the 83 patients enrolled, 39 patients completed the treatment. There were no statistically significant differences in lateral jaw movements or clicking, and no significant difference in MRI findings between the three studied groups before and after the intervention. The OMT group showed a statistically significant difference in pain (p = 0.001), and MIO (p = 0.043) where patients experienced mild pain and slight limitation in mouth opening after 3 months of follow-up in comparison to MAD and CPAP groups.ConclusionCPAP and MAD are better for preserving the health of TMJ in the treatment of OSA patients. While OMT showed mild pain and slight limitation of MIO (that is still within the normal range of mouth opening) compared to CPAP and MAD.Trial registrationThe study was listed on www.Clinicaltrialsgov with registration number (NCT05510882) on 22/08/2022.

Dataset Information

Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea.

Publications

Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea.

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