Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence (NCT03897062) | Clinical Trial Compass
TerminatedPhase 2
Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
Stopped: Recruitment problems during covid lockdowns resulted in Merck ceasing supply of suvorexant/placebo
Australia22 participantsStarted 2019-08-26
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep measure
Timeframe: 7-10 days
Trial details
NCT IDNCT03897062
SponsorThe Florey Institute of Neuroscience and Mental Health