Melatonin Use for Sleep Problems in Alcohol Dependent Patients

NCT03043443 | Completed Phase 2

• 1 other identifier: 099-2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alcohol-Related Disorders

Keywords

sleep; Alcohol dependence; Melatonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PSQI subscales

  1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Melatonin

ACTIVE COMPARATOR

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

Drug: Melatonin

Interventions

Melatonin DRUG

Natural health product for sleep problems treatment

Also known as: melatonin 5 mg oral tablets

Melatonin

Placebo DRUG

Lactose containing pills

Also known as: Lactose pills

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (2)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 1S8, Canada

Location

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Alcohol-Related Disorders; Alcoholism

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bernard LeFoll, MD

  Centre of addiction and mental health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

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

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 6, 2017
• Study Start: January 25, 2017
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: February 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)