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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03897062
Registration number
NCT03897062
Ethics application status
Date submitted
26/03/2019
Date registered
1/04/2019
Date last updated
15/02/2023
Titles & IDs
Public title
Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
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Scientific title
A Placebo-controlled, Double -Blind Randomised Trial of Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
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Secondary ID [1]
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49730
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insomnia
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Alcohol Use Disorder
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Mental Health
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Addiction
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Suvorexant 20 mg
Other interventions - placebo
Active Comparator: Treatment group - Patients (n=64): 20mg tablets of suvorexant nocte daily for six months
Placebo Comparator: Placebo group - Placebo control group: Patients (n=64): 1 placebo tablet nocte daily for six months in addition to treatment as usual
Treatment: Drugs: Suvorexant 20 mg
Placebo controlled double blind suvorexant vs placebo
Other interventions: placebo
Placebo controlled double blind suvorexant vs placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Sleep measure
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Assessment method [1]
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Change in polysomnography sleep efficiency measure from baseline and at end of inpatient stay. Portable Polysomnography is multichannel recording of the electrophysiological markers of sleep. Polysomnography (PSG) records brain activity, eye movements and muscle tone to identify stages of sleep. Sleep efficiency measure is number of minutes of sleep divided by the number of minutes in bed {%}).
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Timepoint [1]
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7-10 days
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Secondary outcome [1]
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Sleep measure
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Assessment method [1]
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Changed ISI scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. The ISI is 7 questions (0-4) with a maximum score of 28 for severe insomnia. The investigators anticipate a change in total score.
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Timepoint [1]
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25 weeks
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Secondary outcome [2]
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Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
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Assessment method [2]
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Changed Pittsburgh Sleep Quality Index (PSQI) scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. The PSQI is a battery of 9 questions (scores 0-3). A total score of 5 or more indicates poor sleep. The investigators anticipate a change in total score.
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Timepoint [2]
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25 weeks
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Secondary outcome [3]
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Sleepiness measure
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Assessment method [3]
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Changed Epworth Sleepiness Scale scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. There are 8 questions with scores of 0-3, maximum score of 24 indicates excessive sleepiness. A change in total score is anticipated.
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Timepoint [3]
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25 weeks
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Secondary outcome [4]
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Abstinence measure
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Assessment method [4]
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Abstinence rates from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%)
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Timepoint [4]
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25 weeks
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Secondary outcome [5]
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Relapse measure
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Assessment method [5]
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Relapse to heavy drinking (>5 drinks/day) from baseline to 5 weeks, 9, 13, 17, 21, 25 weeks
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Timepoint [5]
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25 weeks
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Secondary outcome [6]
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Craving measure
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Assessment method [6]
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Change in alcohol craving measures using the Obsessive Compulsive Drinking Scale from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks. This scale is made up of 14 questions (0-4 range). The higher the total score, the greater the craving. The investigators anticipate a change in total score.
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Timepoint [6]
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25 weeks
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Secondary outcome [7]
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Liver function measure
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Assessment method [7]
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Liver function change [Aspartate aminotransferase (AST) and Gamma-glutamyltransferase (GGT) levels] from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%)
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Timepoint [7]
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25 weeks
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Secondary outcome [8]
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Urine drug screen
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Assessment method [8]
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Urine drug screens negative for drugs other than alcohol from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%)
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Timepoint [8]
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25 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 ßHCG 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/07/2022
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Sample size
Target
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3065 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Florey Institute of Neuroscience and Mental Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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St Vincent's Hospital Melbourne
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Melbourne Health
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03897062
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Trial related presentations / publications
Walker LC, Lawrence AJ. The Role of Orexins/Hypocretins in Alcohol Use and Abuse. Curr Top Behav Neurosci. 2017;33:221-246. doi: 10.1007/7854_2016_55.
Lawrence AJ, Cowen MS, Yang HJ, Chen F, Oldfield B. The orexin system regulates alcohol-seeking in rats. Br J Pharmacol. 2006 Jul;148(6):752-9. doi: 10.1038/sj.bjp.0706789. Epub 2006 Jun 5.
von der Goltz C, Koopmann A, Dinter C, Richter A, Grosshans M, Fink T, Wiedemann K, Kiefer F. Involvement of orexin in the regulation of stress, depression and reward in alcohol dependence. Horm Behav. 2011 Nov;60(5):644-50. doi: 10.1016/j.yhbeh.2011.08.017. Epub 2011 Sep 16.
Brower KJ. Insomnia, alcoholism and relapse. Sleep Med Rev. 2003 Dec;7(6):523-39. doi: 10.1016/s1087-0792(03)90005-0.
Roehrs T, Roth T. Sleep, sleepiness, and alcohol use. Alcohol Res Health. 2001;25(2):101-9.
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Public notes
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Contacts
Principal investigator
Name
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Andrew Lawrence
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Address
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Florey Institute of Neuroscience & Mental Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03897062
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