Bright Light Therapy During Residential Alcohol Withdrawal

NCT ID: NCT06878287

Last Updated: 2025-03-14

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2025-05-31

Brief Summary

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This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.

Detailed Description

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All eligible patients will be offered and explained the study by a psychiatrist/addictologist during the consultation (or teleconsultation) to schedule a 14-day hospitalization for alcohol withdrawal (maximum 3 months before hospitalization). Patients will be randomized centrally to one of the following two treatment conditions (blind maintained by a nurse independent of the assessment), on day D0 of inpatient treatment for withdrawal (standardized withdrawal over 14 days with hydration, vitamin B1, benzodiazepines in gradual decrease before stopping and according to signs of withdrawal):

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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Alcohol Use Disorder Alcohol Withdrawal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

Light therapy every morning (8 am-8.30 am)

Group Type ACTIVE_COMPARATOR

Light exposure

Intervention Type OTHER

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)

Group Type PLACEBO_COMPARATOR

Placebo light

Intervention Type OTHER

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)

Intervention Type OTHER

Placebo light

30 minutes exposure to the same device using a filter inactivating light intensity (\< 10 lux)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients must be aged from 18 to 65 years old and have a diagnosis of Alcohol Use Disorder
* 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

* Ophthalmic pathology (cataract, macular degeneration, glaucoma, retinitis pigmentosa) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier St Anne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Alexis GEOFFROY, PhD

Role: CONTACT

+33140256048

Sibylle MAURIES, Ph

Role: CONTACT

+330140256272

Facility Contacts

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Michel LEJOYEUX, Psychiatrist

Role: primary

01 40 25 82 62

Other Identifiers

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D20-P49

Identifier Type: -

Identifier Source: org_study_id

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