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Front Psychiatry. 2013 Jan 22;4:1. doi: 10.3389/fpsyt.2013.00001. eCollection 2013.

Proof of concept trial of dronabinol in obstructive sleep apnea.

Author information

1
Department of Medicine, University of Illinois at Chicago Chicago, IL, USA.

Abstract

STUDY OBJECTIVE:

Animal data suggest that Δ(9)-TetraHydroCannabinol (Δ(9)THC) 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(9)THC), 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.

KEYWORDS:

OSA; apnea; clinical trial; dronabinol; drug treatment; placebo-controlled; randomized

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