Bright Light Therapy During Residential Alcohol Withdrawal

Centre Hospitalier St Anne100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Alcohol Use Disorder Alcohol Withdrawal

Interventions

Light exposureOTHER

30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking)

Placebo lightOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Adult Emergency Department - Bichât Hospital

Paris, Île-de-France Region, France

RECRUITING

Outcomes

Primary Outcomes

Alcohol relapse or lapse

Assessment of alcohol intake at the follow-up visits using a Timeline Followback. Relapse : any heavy drinking day, i.e. 5 or more drinks/day for a man or 4 or more drinks/day for a woman, as defined by the NIAAA (2005) and the FDA (2015), and/or 14 drinks or more per week for at least 4 weeks. Lapse : any alcohol intake not meeting the criteria for relapse

Time frame: 4 and 12 weeks

Secondary Outcomes

Actigraphy

Wristwatch actigraph delivered at inclusion, which allows measurement of activity and sleep-wake parameters using an accelerometer worn on the wrist MotionWatch8 from CamNTech®

Time frame: 1 day and third week

Alcohol withdrawal severity

Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) : maximum and mean score on the first 5 days after admission

Time frame: 2 weeks

Circadian typology

Chronotype questionnaire (Horne \& Östberg) a

Time frame: At inclusion

Alcohol craving

Obsessive Compulsive Drinking Scale (OCDS)

Time frame: At inclusion, 1, 2, 4 and 12 weeks

Depressive and anxious symptomatology

* Montgomery-Åsberg Depression Rating Scale (MADRS) * Self-questionnaire : QIDS-SD16 and GAD-7

Time frame: At inclusion, 1, 2, 4 and 12 weeks

Suicidal risk

Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame: At inclusion, 1, 2, 4 and 12 weeks

Central Contacts

Pierre Alexis GEOFFROY, PhD

CONTACT

+33140256048 pierrealexis.geoffroy@aphp.fr

Sibylle MAURIES, Ph

CONTACT

+330140256272 sibylle.mauries@aphp.fr

Data from ClinicalTrials.gov

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