Melatonin Use for Sleep Problems in Alcohol Dependent Patients

January 31, 2019 updated by: Bernard Le Foll, Centre for Addiction and Mental Health

Melatonin for Alcohol Use Disorder Patients With Sleeping Problems

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1S8
        • Centre for Addiction and Mental Health
      • Toronto, Ontario, Canada, M5S 2S1
        • Center for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • melatonin 5 mg oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Bernard LeFoll, MD, Centre of Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 25, 2017

Primary Completion (ACTUAL)

January 10, 2019

Study Completion (ACTUAL)

January 10, 2019

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (ESTIMATE)

February 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 099-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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