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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Placebo-controlled, Double -Blind Randomised Trial of Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
Secondary ID [1] 0 0
49730
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 0 0
Alcohol Use Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Addiction
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sleep measure
Timepoint [1] 0 0
7-10 days
Secondary outcome [1] 0 0
Sleep measure
Timepoint [1] 0 0
25 weeks
Secondary outcome [2] 0 0
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 0 0
25 weeks
Secondary outcome [3] 0 0
Sleepiness measure
Timepoint [3] 0 0
25 weeks
Secondary outcome [4] 0 0
Abstinence measure
Timepoint [4] 0 0
25 weeks
Secondary outcome [5] 0 0
Relapse measure
Timepoint [5] 0 0
25 weeks
Secondary outcome [6] 0 0
Craving measure
Timepoint [6] 0 0
25 weeks
Secondary outcome [7] 0 0
Liver function measure
Timepoint [7] 0 0
25 weeks
Secondary outcome [8] 0 0
Urine drug screen
Timepoint [8] 0 0
25 weeks

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2022
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Florey Institute of Neuroscience and Mental Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Melbourne Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03897062
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.
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Lawrence
Address 0 0
Florey Institute of Neuroscience & Mental Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03897062