Alcohol-Related DisordersPhase 2NCT03043443
Melatonin Use for Sleep Problems in Alcohol Dependent Patients
A Phase 2 study testing Melatonin in people with Alcohol-Related Disorders, run by Centre for Addiction and Mental Health at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alcohol-Related Disorders
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Jan 2017to 10 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 1S8
Center for Addiction and Mental Health
Toronto, Ontario, M5S 2S1
About this study
Official title: Melatonin for Alcohol Use Disorder Patients With Sleeping Problems
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.
Read the detailed 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.
- Conditions
- Alcohol-Related Disorders
- Being tested
- Melatonin, Placebo
- Keywords
- sleep, Alcohol dependence, Melatonin
- Medical subject headings
- Alcohol-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called melatonin 5 mg oral tablets
Natural health product for sleep problems treatment
PlaceboDrug
Also called Lactose pills
Lactose containing pills
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | participants will receive placebo 1 capsule/day 1 hour before sleeping for 4 weeks Receives: Drug: Placebo |
| Melatonin | Active comparator | participants will receive melatonin 1 capsule (5mg)/day 1 hour before sleeping for 4 weeks Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start25 Jan 2017
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Bernard LeFoll, MD, Principal investigator, Centre of addiction and mental health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043443
- Sponsor's protocol ID
- 099-2016
- Status last verified
- Jan 2019
- First submitted
- 1 Feb 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin for Alcohol Use Disorder Patients With Sleeping Problems
- ClinicalTrials.gov ID
- NCT03043443
- Acronym / sponsor ID
- 099-2016
- Conditions
- Alcohol-Related Disorders
- Keywords
- sleep, Alcohol dependence, Melatonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment Melatonin or Placebo arms.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboparticipants will receive placebo 1 capsule/day 1 hour before sleeping for 4 weeks |
| Melatonin | Active comparator | Drug: Melatoninparticipants will receive melatonin 1 capsule (5mg)/day 1 hour before sleeping for 4 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: melatonin 5 mg oral tabletsNatural health product for sleep problems treatment | Drug | Melatonin |
| PlaceboAlso: Lactose pillsLactose containing pills | Drug | Placebo |
Primary outcome
PSQI score
Time frame: 1 month
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 secondary outcome
PSQI subscales
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard LeFoll, MD principal investigator
Centre of addiction and mental health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Alcohol-Related Disorders, run by Centre for Addiction and Mental Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQI score (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019; AzTrials last refreshed its copy on 26 Oct 2026.