Skip to main content
OpenTrials
Completed

NCT Number: NCT03043443

Melatonin Use for Sleep Problems in Alcohol Dependent Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Addiction and Mental Health, Toronto, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

Natural health product for sleep problems treatment

Other names: melatonin 5 mg oral tablets

Placebo

Drug

Lactose containing pills

Other names: Lactose pills

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

Melatonin for Alcohol Use Disorder Patients With Sleeping Problems

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2017
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.