MedTrace Logo

Melatonin Use for Sleep Problems in Alcohol Dependent Patients

NCT03043443 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-02-04

No results posted yet for this study

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

Interventions

DRUG

Melatonin

Natural health product for sleep problems treatment

DRUG

Placebo

Lactose containing pills

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Bernard LeFoll, MD · Centre of addiction and mental health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-25
Primary Completion
2019-01-10
Completion
2019-01-10

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043443 on ClinicalTrials.gov