Bright Light Therapy During Residential Alcohol Withdrawal (LUNA)

Bright Light Therapy During Residential Alcohol Withdrawal : a Double Blind Randomized Placebo Controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder; Alcohol Withdrawal
• Intervention / Treatment: Other: Light exposure; Other: Placebo light

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Alexis GEOFFROY, PhD; Phone Number: +33140256048; Email: pierrealexis.geoffroy@aphp.fr
• Study Contact Backup: Name: Sibylle MAURIES, Ph; Phone Number: +330140256272; Email: sibylle.mauries@aphp.fr

Study Locations

• France
  • Île-de-France
    • Paris, Île-de-France, France, 75018
      • Recruiting
      • Adult Emergency Department - Bichât Hospital
      • Contact: Michel LEJOYEUX, Psychiatrist; Phone Number: 01 40 25 82 62

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental group; Light therapy every morning (8 am-8.30 am)	Other: Light exposure; 30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking)
Placebo Comparator: Control group; Dim-Light exposure every morning (8 am-8.30 am)	Other: Placebo light; 30 minutes exposure to the same device using a filter inactivating light intensity (< 10 lux)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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®	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	2 weeks
Circadian typology	Chronotype questionnaire (Horne & Östberg) a	At inclusion
Alcohol craving	Obsessive Compulsive Drinking Scale (OCDS)	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	At inclusion, 1, 2, 4 and 12 weeks
Suicidal risk	Columbia-Suicide Severity Rating Scale (C-SSRS)	At inclusion, 1, 2, 4 and 12 weeks
Cognitive impairment	Montreal Cognitive Assessment (MoCA) : three different versions	At inclusion, 2 and 12 weeks
Light therapy tolerance	Side effects questionnaire designed for a previous study	At 2 weeks
Polysomnography	Sleep recording at the sleep laboratory, measuring : Sleep stages; Total Sleep Time; Sleep Efficiency; Number of awakenings or arousals; Snoring; Apnea-Hypopnea Index (AHI); Periodic Limb Movements	1 week
Subjective quality of sleep	Pittsburgh Sleep Quality Index (PSQI)	12 weeks
Number of days with 2 drinks or more	% of days with 2 drinks or more at the follow-up visits	4, 12 weeks
Heavy drinking days	% of heavy drinking days at the follow-up visits	4, 12 weeks
Days with no drinking	% of days with no drinking at the follow-up visits	4, 12 weeks
Percent with complete abstinence	% of subjects with no drinking at the follow-up visits	4 and 12 weeks
Number of individuals in relapse	% of subjects meeting criteria for relapse at the follow-up visits	4 , 12 weeks
Sleep diary	sleep diary.give at the first appointment then fill in every day	From inclusion to third week
Circadian typology	seasonal profile (SPAQ)	one day
Actigraphy	Wristwatch actigraph delivered at inclusion, which allows measurement of activity and sleep-wake parameters using an accelerometer worn on the wrist ScanWatch from Withings®	one day to third week
Alcohol withdrawal severity	mean benzodiazepine dosage required by day during the 2 weeks of treatment	one day to 2 weeks
Subjective quality of sleep	Insomnia Severity Index (ISI)	one day, 2 day to12 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Principal Investigator: Pierre Alexis GEOFFROY, PhD, University Hospital Group for Psychiatry and Neurosciences

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: D20-P49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No