Melatonin Use for Sleep Problems in Alcohol Dependent Patients

Alcohol-Related Disorders Clinical Trial

Official title:

Melatonin for Alcohol Use Disorder Patients With Sleeping Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043443
• Other study ID #: 099-2016
• Status: Completed
• Phase: Phase 2
• Start date: January 25, 2017
• Est. completion date: January 10, 2019

Study information

• Verified date: January 2019
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol-Related Disorders

Intervention

Drug:
• Melatonin
Natural health product for sleep problems treatment
• Placebo
Lactose containing pills

Locations

Country	Name	City	State
Canada	Center for Addiction and Mental Health	Toronto	Ontario
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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