Bright Light Therapy During Residential Alcohol Withdrawal (LUNA)

Centre Hospitalier St Anne

Status: Enrolling

Conditions: Alcohol Withdrawal; Alcohol Use Disorder

Treatments: Other: Light exposure; Other: Placebo light

Study type: Interventional

Funder types: Other

Identifiers

NCT06878287

D20-P49

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Experimental group

Active Comparator group

Description:

Light therapy every morning (8 am-8.30 am)

Treatment:

Other: Light exposure

Control group

Placebo Comparator group

Description:

Dim-Light exposure every morning (8 am-8.30 am)

Treatment:

Other: Placebo light