Melatonin Use for Sleep Problems in Alcohol Dependent Patients

• Status: Completed
• Trial end date: 2019-01-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Treatments: Ethanol; Melatonin

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.