- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03043443
Melatonin Use for Sleep Problems in Alcohol Dependent Patients
Melatonin for Alcohol Use Disorder Patients With Sleeping Problems
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Lactose containing pills
Other Names:
|
ACTIVE_COMPARATOR: Melatonin
participants will receive melatonin 1 capsule (5mg)/day 1 hour before sleeping for 4 weeks
|
Natural health product for sleep problems treatment
Other Names:
|
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
Investigators
- Principal Investigator: Bernard LeFoll, MD, Centre of Addiction and Mental Health
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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