Melatonin Use for Sleep Problems in Alcohol Dependent Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Melatonin for Alcohol Use Disorder Patients With Sleeping Problems

Conditions
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Alcohol-Related Disorders

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>participants will receive placebo 1 capsule/day 1 hour before sleeping for 4 weeks | Drug: Placebo<br>* Lactose containing pills<br>* Other names: Lactose pills;|
| Active Comparator: Melatonin<br>participants will receive melatonin 1 capsule (5mg)/day 1 hour before sleeping for 4 weeks | Drug: Melatonin<br>* Natural health product for sleep problems treatment<br>* Other names: melatonin 5 mg oral tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSQI score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, Alcohol dependence, Melatonin