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Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897062
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
St Vincent's Hospital Melbourne
Melbourne Health
Information provided by (Responsible Party):
The Florey Institute of Neuroscience and Mental Health

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.


Condition or disease Intervention/treatment Phase
Insomnia Alcohol Use Disorder Drug: Suvorexant 20 mg Other: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A placebo-controlled, double-blind randomised trial
Masking: Single (Outcomes Assessor)
Masking Description: Patients will be treated from pre-packaged blinded treatment schedules.
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double -Blind Randomised Trial of Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Suvorexant

Arm Intervention/treatment
Active Comparator: Treatment group
Patients (n=64): 20mg tablets of suvorexant nocte daily for six months
Drug: Suvorexant 20 mg
Placebo controlled double blind suvorexant vs placebo

Placebo Comparator: Placebo group
Placebo control group: Patients (n=64): 1 placebo tablet nocte daily for six months in addition to treatment as usual
Other: placebo
Placebo controlled double blind suvorexant vs placebo




Primary Outcome Measures :
  1. Sleep measure [ Time Frame: 7-10 days ]
    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 {%}).


Secondary Outcome Measures :
  1. Sleep measure [ Time Frame: 25 weeks ]
    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.

  2. Sleep quality: Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 25 weeks ]
    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.

  3. Sleepiness measure [ Time Frame: 25 weeks ]
    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.

  4. Abstinence measure [ Time Frame: 25 weeks ]
    Abstinence rates from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%)

  5. Relapse measure [ Time Frame: 25 weeks ]
    Relapse to heavy drinking (>5 drinks/day) from baseline to 5 weeks, 9, 13, 17, 21, 25 weeks

  6. Craving measure [ Time Frame: 25 weeks ]
    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.

  7. Liver function measure [ Time Frame: 25 weeks ]
    Liver function change [Aspartate aminotransferase (AST) and Gamma-glutamyltransferase (GGT) levels] from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%)

  8. Urine drug screen [ Time Frame: 25 weeks ]
    Urine drug screens negative for drugs other than alcohol from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897062


Contacts
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Contact: Chief Investigator (03) 9231 2627 Yvonne.bonomo@svha.org.au
Contact: Chief Investigator (03) 90356692 Andrew.Lawrence@florey.edu.au

Locations
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Australia, Victoria
St Vincent's Hospital Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Yvonne Bonomo       Yvonne.BONOMO@svha.org.au   
Sponsors and Collaborators
The Florey Institute of Neuroscience and Mental Health
St Vincent's Hospital Melbourne
Melbourne Health
Investigators
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Principal Investigator: Andrew Lawrence Florey Institute of Neuroscience & Mental Health
Principal Investigator: Yvonne Bonomo St Vincent's Hospital Melbourne

Publications:
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Responsible Party: The Florey Institute of Neuroscience and Mental Health
ClinicalTrials.gov Identifier: NCT03897062    
Other Study ID Numbers: 49730
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by The Florey Institute of Neuroscience and Mental Health:
suvorexant
insomnia
alcohol use disorder
craving
withdrawal
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Disease
Alcoholism
Alcohol Drinking
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Neurologic Manifestations
Signs and Symptoms
Ethanol
Suvorexant
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action