NCT03897062

Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

Terminated Phase 2 Last updated 15 February 2023

What this trial tests

Phase 2 trial testing Suvorexant 20 mg in Insomnia in 22 participants. Terminated before completion.

Timeline

26 August 2019

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	The Florey Institute of Neuroscience and Mental Health
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	22
Start date	26 August 2019
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across Australia

Drugs / interventions tested

• Suvorexant 20 mg — full drug profile →
• placebo

Conditions studied

• Insomnia — all drugs for Insomnia →
• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

The Florey Institute of Neuroscience and Mental Health

Who can join

Adults 18 to 75, any sex, with Insomnia or Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. It may also have a role in addictions as the orexins play a critical role in drug addiction and reward-related behaviours. Orexins appear to be involved in both alcohol withdrawal and in alcohol seeking triggered by external cues (eg contexts or stressors) through both OX1 and OX2 receptor signalling. Chief investigator, Professor Lawrence was the first to demonstrate a role for endogenous orexin signaling in alcohol-seeking. Alcohol is known to effect the sleep of healthy and alcohol dependent individuals with effects on daytime sleepiness, physiological functions during sleep, and the development of sleep disorders. There are various estimates of the co-occurrence of insomnia and alcohol use disorder ranging from 36-72%. In alcohol dependent individuals sleep is disturbed both while drinking and for months of abstinence and abstinent sleep disturbance is predictive of relapse.

This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients undergoing acute alcohol withdrawal and thereafter for six months. The study will also examine the effectiveness of suvorexant in reducing craving for alcohol and promoting duration of abstinence. This will be the first double blind controlled trial of suvorexant in the management of the alcohol withdrawal syndrome and maintenance of abstinence post withdrawal.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder.
   Burnette EM, Nieto SJ, Grodin EN, Meredith LR, et al · · 2022 · cited 119× · PMID 35133639 · DOI 10.1007/s40265-021-01670-3
2. Repurposing the dual orexin receptor antagonist suvorexant for the treatment of opioid use disorder: why sleep on this any longer?
   James MH, Fragale JE, Aurora RN, Cooperman NA, et al · · 2020 · cited 43× · PMID 31986520 · DOI 10.1038/s41386-020-0619-x
3. The Insomnia-Addiction Positive Feedback Loop: Role of the Orexin System.
   Fragale JE, James MH, Avila JA, Spaeth AM, et al · · 2021 · cited 35× · PMID 34052815 · DOI 10.1159/000514965
4. Orexin (hypocretin) and addiction.
   Mehr JB, Bilotti MM, James MH. · · 2021 · cited 33× · PMID 34642086 · DOI 10.1016/j.tins.2021.09.002
5. Alternative use of suvorexant (Belsomra^®) for the prevention of alcohol drinking and seeking in rats with a history of alcohol dependence.
   Flores-Ramirez FJ, Illenberger JM, Pascasio GE, Matzeu A, et al · · 2022 · cited 22× · PMID 36620860 · DOI 10.3389/fnbeh.2022.1085882
6. Opioid Use Disorder, Sleep Deficiency, and Ventilatory Control: Bidirectional Mechanisms and Therapeutic Targets.
   Eckert DJ, Yaggi HK. · · 2022 · cited 18× · PMID 35649170 · DOI 10.1164/rccm.202108-2014ci
7. Sleep Deficiency and Opioid Use Disorder: Trajectory, Mechanisms, and Interventions.
   Langstengel J, Yaggi HK. · · 2022 · cited 17× · PMID 35659031 · DOI 10.1016/j.ccm.2022.05.001
8. Current and potential pharmacological treatment options for insomnia in patients with alcohol use disorder in recovery.
   Roehrs TA, Auciello J, Tseng J, Whiteside G. · · 2020 · cited 14× · PMID 32543111 · DOI 10.1002/npr2.12117