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Melatonin Use for Sleep Problems in Alcohol Dependent Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03043443
Recruitment Status : Completed
First Posted : February 6, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health

Brief Summary:
A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment Melatonin or Placebo arms. All subjects will be assessed at baseline for demographics. Sleeping problems will be the primary outcome of the study, and it will be measured by the Pittsburgh sleep quality index (PSQI) scale.

Condition or disease Intervention/treatment Phase
Alcohol-Related Disorders Drug: Melatonin Drug: Placebo Phase 2

Detailed Description:
A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to either Melatonin or Placebo arms. All subjects will complete some forms on the REDCap system such as contact information list, concomitant medication, Time Line Follow Back (TLFB), Fagerstrom test for nicotine dependence (FTND), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), AUD criteria, and Alcohol use disorder identification test (AUDIT). Sleeping problems will be the primary outcome of the study, and it will be measured by the Pittsburgh sleep quality index (PSQI) scale where score 5 or more indicated a sleeping problem. Women in child-bearing period will be asked to do a urine pregnancy test to exclude pregnancy. After verifying eligibility, the participants will come to pick up the medication (Melatonin or placebo) blister together with a sleep hygiene document and will start taking the medication for 4 weeks. All subjects will then be followed-up at the end of 1 month of treatment and PSQI score will be measured. This step will be completed either online by sending an email link through or the participants can come to a personal visit to complete the second PSQI form. Also, this last visit/email will contain side effects questionnaire, TLFB, BDI, BAI. All the participants will be required to bring/send back the medication blister pack to do a pill count and check all the missing pills.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment Melatonin or Placebo arms.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin for Alcohol Use Disorder Patients With Sleeping Problems
Actual Study Start Date : January 25, 2017
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Placebo Comparator: Placebo
participants will receive placebo 1 capsule/day 1 hour before sleeping for 4 weeks
Drug: Placebo
Lactose containing pills
Other Name: Lactose pills

Active Comparator: Melatonin
participants will receive melatonin 1 capsule (5mg)/day 1 hour before sleeping for 4 weeks
Drug: Melatonin
Natural health product for sleep problems treatment
Other Name: melatonin 5 mg oral tablets




Primary Outcome Measures :
  1. PSQI score [ Time Frame: 1 month ]
    The primary outcome of the study is PSQI score. This will be analyzed by the difference in the global score before and after the use of melatonin versus placebo. Score > 5 indicates a sleep problem.


Secondary Outcome Measures :
  1. PSQI subscales [ Time Frame: 1 month ]

    Secondary outcome measures will include the subscales of PSQI: 1) subjective quality of sleep; 2) sleep onset latency; 3) sleep duration; 4) sleep efficiency; 5) presence of sleep disturbances; and 6) presence of daytime disturbances, as an indication of daytime alertness.

    As according to previous studies, melatonin showed a significant decrease in sleep onset latency and an improvement in daytime alertness.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 19 or older
  • AUD in any stage
  • Sleep problems in the past month
  • PSQI score > 5 at baseline
  • Participants must agree not to use other sleep aid during the study
  • Women capable of becoming pregnant must agree to use contraceptives during study

Exclusion Criteria:

  • Pregnancy, lactation or plans to become pregnant during the study timeline.
  • Use of other sleep aid in the past month (either prescribed or over the counter remedies)
  • Use of benzodiazepines and/or Z- drugs: (zaleplon, zolpidem and zopiclone) in the past month
  • Known allergy to melatonin
  • Participants taking immunosuppressive drugs.

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): NCT03043443


Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 1S8
Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Bernard LeFoll, MD Centre of addiction and mental health

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Responsible Party: Bernard Le Foll, Dr., Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03043443     History of Changes
Other Study ID Numbers: 099-2016
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bernard Le Foll, Centre for Addiction and Mental Health:
sleep
Alcohol dependence
Melatonin
Additional relevant MeSH terms:
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Melatonin
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents