Melatonin Use for Sleep Problems in Alcohol Dependent Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2019-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program

NCT02431728

Substance Withdrawal Syndrome

COMPLETED PHASE1/PHASE2

Treatment of Young Adults With Comorbid AUD/MDD: A Pilot Medication Trial

NCT02646449

Major Depressive Disorder Alcohol Use Disorder

COMPLETED PHASE2

A Placebo-Controlled Trial of Memantine for Alcohol Dependence

NCT00246415

Alcohol Dependence (Primary Condition) Alcohol Abuse

COMPLETED PHASE2

Reducing Alcohol Use in Depressed Patients

NCT00183079

Depression Alcohol Use

COMPLETED PHASE2

Modafinil for the Treatment of Alcohol Use Disorders

NCT03424681

Alcohol Use Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol-Related Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment Melatonin or Placebo arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

participants will receive placebo 1 capsule/day 1 hour before sleeping for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Lactose containing pills

Melatonin

participants will receive melatonin 1 capsule (5mg)/day 1 hour before sleeping for 4 weeks

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

Natural health product for sleep problems treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin

Natural health product for sleep problems treatment

Intervention Type DRUG

Placebo

Lactose containing pills

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

melatonin 5 mg oral tablets Lactose pills

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No