Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001226493
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/09/2025
Date registered
Help: Date registered
5/11/2025
Date last updated
Help: Date last updated
5/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
5/11/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
An open label pilot trial of suvorexant for the management of comorbid insomnia and alcohol use disorder
Scientific title
SAILOR (SuvorexAnt for Insomnia and aLcohOl use disordeR): An open label pilot feasibility trial of suvorexant for the management of comorbid insomnia and alcohol use disorder
Additional trial identifiers [1] 314222 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SAILOR (SuvorexAnt for Insomnia and aLcohOl use disordeR)
Related trial records

Health condition
Health condition(s) studied:
Insomnia 337125 0
Alcohol Use Disorder 337126 0
Condition category
Condition code
Mental Health 333544 333544 0 0
Addiction
Neurological 335333 335333 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
An open label study investigating 20mg of suvorexant (oral tablet) once per evening, for 14 days. Intervention adherence will be assessed via pill count at Day 8 and Day 15.

An initial screening visit will be conducted, a maximum of 14 days prior to enrolment in the study. During the Screening visit, potentially eligible individuals will be asked to provide informed consent prior to undergoing a full eligibility assessment at an appointment with a trial physician and study researcher at the study site.
Intervention code [1] 330833 0
Treatment: Drugs
Description of the comparator or control
None, open label study with no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341128 0
Feasibility
Timepoint [1] 341128 0
Assessed at the conclusion of the study
Primary outcome [2] 342951 0
Feasibility
Timepoint [2] 342951 0
Assessed at the conclusion of the study
Secondary outcome [1] 446376 0
Tolerability
Timepoint [1] 446376 0
22 days post-intervention commencement follow-up relative to commencement of intervention. Assessed at baseline and day 22 (number of participants who did not complete the follow-up visit).
Secondary outcome [2] 446377 0
Time to last alcohol consumption
Timepoint [2] 446377 0
Daily from Baseline to end of treatment (day 15 post-intervention commencement).
Secondary outcome [3] 446378 0
Insomnia
Timepoint [3] 446378 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [4] 446381 0
Subjective measures of sleep
Timepoint [4] 446381 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [5] 451954 0
Alcohol craving
Timepoint [5] 451954 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [6] 451955 0
Psychosocial well-being
Timepoint [6] 451955 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [7] 453398 0
Tolerability
Timepoint [7] 453398 0
22 days post-intervention commencement follow-up relative to commencement of intervention. Assessed at baseline and day 22 (number of participants who did not complete the follow-up visit).
Secondary outcome [8] 453399 0
Insomnia
Timepoint [8] 453399 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [9] 453400 0
Insomnia
Timepoint [9] 453400 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [10] 453401 0
Insomnia
Timepoint [10] 453401 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [11] 453402 0
Insomnia
Timepoint [11] 453402 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [12] 453403 0
Subjective measures of sleep
Timepoint [12] 453403 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [13] 453404 0
Subjective measures of sleep
Timepoint [13] 453404 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [14] 453405 0
Alcohol craving
Timepoint [14] 453405 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [15] 453406 0
Psychological well-being
Timepoint [15] 453406 0
At Baseline to end of treatment (day 15 post intervention commencement).
Secondary outcome [16] 453407 0
Psychological well-being
Timepoint [16] 453407 0
At Baseline to end of treatment (day 15 post intervention commencement).

Eligibility
Key inclusion criteria
Moderate to severe Alcohol Use Disorder (AUD) within the past 12-months according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria.

Recent (within 10 days of screening) supervised alcohol detoxification (inpatient or otherwise).

At least 7 days and not more than 1 month since last alcoholic beverage intake at the time of study screening.

Meet study criteria for insomnia, defined as an Insomnia Severity Index (ISI) score of 15 or more.

Age 18-65 years at the time of enrolment.

Body mass index > 30 at the time of screening

Adequate cognition and English language skills to give valid consent and complete research interviews.

Stable housing.

Willingness to participate and give written informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Pregnancy or lactation (people of child-bearing capability will be advised to use reliable contraception during the study and a pregnancy test will be performed where necessary).

Current use of antihistamines, strong or moderate inhibitors of CYP3A liver enzymes, strong CYP3A inducers, or digoxin and/ or other medications that are contraindicated with suvorexant (listed in the Exclusionary Medications document).

Meeting DSM-5 criteria for any substance use disorder other than alcohol and/ or nicotine.

Clinically significant or unstable systemic medical condition (e.g., cancer, end stage liver disease) or psychiatric disorder (e.g. a current major depressive disorder – informed by the BDI, severe anxiety – informed by the BAI, active suicide risk – informed by the SIDAS) that, in the opinion of the investigator, precludes study participation.

Diagnosis of, or suspected sleep disorder other than insomnia (e.g. sleep apnoea defined by STOP-BANG score greater than or equal to 5, narcolepsy, restless legs syndrome)

Any alcohol pharmacotherapy within 30 days prior to start of study treatment.
Significant alcohol withdrawal [current Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) score greater than or equal to 10]

Severe hepatic or renal impairment [defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3× upper limit of normal (ULN), total bilirubin > 2× ULN, or creatinine > 1.5× ULN].

Shift-worker.

Inability to take oral medication.

Known sensitivity to suvorexant.

Currently participating in another clinical trial with an investigational drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2026
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 318739 0
Government body
Name [1] 318739 0
NHMRC Synergy grant
Country [1] 318739 0
Australia
Primary sponsor type
Government body
Name
Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 321177 0
None
Name [1] 321177 0
Address [1] 321177 0
Country [1] 321177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317352 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 317352 0
Ethics committee country [1] 317352 0
Australia
Date submitted for ethics approval [1] 317352 0
18/12/2024
Approval date [1] 317352 0
21/03/2025
Ethics approval number [1] 317352 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140774 0
A/Prof Shalini Arunogiri
Address 140774 0
Turning Point, level 1 110 Church St, Richmond VIC 3121
Country 140774 0
Australia
Phone 140774 0
+613 8413 8447
Fax 140774 0
Email 140774 0
[email protected]
Contact person for public queries
Name 140775 0
Sarah Catchlove
Address 140775 0
Turning Point, level 1 110 Church St, Richmond VIC 3121
Country 140775 0
Australia
Phone 140775 0
+61 3 8413 8413
Fax 140775 0
Email 140775 0
[email protected]
Contact person for scientific queries
Name 140776 0
Sarah Catchlove
Address 140776 0
Turning Point, level 1 110 Church St, Richmond VIC 3121
Country 140776 0
Australia
Phone 140776 0
+61 3 8413 8413
Fax 140776 0
Email 140776 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.