Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Florey Institute of Neuroscience and Mental Health
• Collaborators: Melbourne Health; St Vincent's Hospital Melbourne
• Treatments: Ethanol; Suvorexant

Criteria

Inclusion Criteria:

• Over 18 years of age and not more than 75 years of age

• DSM-5 diagnosis of insomnia

• Alcohol dependent (SCID-5)

• Willing to comply with treatment and follow-up requirements of study

• Able to give informed consent

Exclusion Criteria:

• Consumes less than 6 standard drinks per day.

• Not alcohol dependent (SCID-5)

• Unstable major psychiatric disorder e.g. active psychosis, significant PTSD.

• Currently taking medication having major interaction with suvorexant

• Pregnant (urine βHCG positive) or not using adequate contraception.

• Breast feeding.

• Severe hepatic impairment (Liver enzyme levels >five times normal level)

• Severe renal impairment (urine creatinine clearance < 30ml/h)

• Severe medical disorder e.g. epilepsy, cardiovascular disorder

• Participating in another pharmacotherapy trial e.g. lorcaserin

• Highly dependent on medical care.

• Driver of any vehicle (car or commercial vehicle)

• Inability to take oral medication.

• No consent to participate in the study

• Known sensitivity to suvorexant.

• Less than 18 years of age

• Over 75 years of age.