Bright Light Therapy During Residential Alcohol Withdrawal
NCT ID: NCT06878287
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-05-31
2025-05-31
Brief Summary
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Detailed Description
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1. Active light therapy (10,000 Lux).
2. Placebo light therapy (with filter \<10 Lux). Every morning in the room (patient in a single room), at 8 am, for 30 min, for the entire duration of withdrawal, i.e. 13 days (start on D1) and stopped on D14.
No change in usual care apart from this intervention.
After checking the inclusion and non-inclusion criteria and obtaining consent, patients will be randomized (ratio 1:1) between the groups with active light therapy or placebo, by connecting to a randomization website (REDCap software) using a randomization list prepared in advance, balanced by block of randomly variable size
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group
Light therapy every morning (8 am-8.30 am)
Light exposure
30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking)
Control group
Dim-Light exposure every morning (8 am-8.30 am)
Placebo light
30 minutes exposure to the same device using a filter inactivating light intensity (\< 10 lux)
Interventions
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Light exposure
30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking)
Placebo light
30 minutes exposure to the same device using a filter inactivating light intensity (\< 10 lux)
Eligibility Criteria
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Inclusion Criteria
* Patients must be intreated for alcohol withdrawal, for at least two weeks
* Patients must report heavy drinking episodes in the past month
* Patients must be able to understand medical information and consent to the treatment
* Patients must be considering a goal of abstinence from alcohol
Exclusion Criteria
* Subjects who have already received light therapy in the last 6 months
* Lactating of pregnant women
* Psychiatric comorbidity requiring an intreatment, or risk of manic episode (subjects with depressive or anxious symptoms compatible with an out-treatment can be included)
* Substance Use Disorder other than alcohol and/or tobacco
* Severe cognitive impairment (MOCA \< 10)
* Patients being under legal protection measure
18 Years
65 Years
ALL
No
Sponsors
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Centre Hospitalier St Anne
OTHER
Responsible Party
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Principal Investigators
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Pierre Alexis GEOFFROY, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Group for Psychiatry and Neurosciences
Locations
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Adult Emergency Department - Bichât Hospital
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Michel LEJOYEUX, Psychiatrist
Role: primary
Other Identifiers
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D20-P49
Identifier Type: -
Identifier Source: org_study_id
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