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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03897062