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NCT Number: NCT06878287

Bright Light Therapy During Residential Alcohol Withdrawal

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

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adult Emergency Department - Bichât Hospital

Paris, Île-de-France Region, 75018, France

Location status: Recruiting

Location contact

Michel LEJOYEUX, Psychiatrist

CONTACT

01 40 25 82 62

About this study

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):

  • Active light therapy (10,000 Lux).
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

light exposure

Other

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

Placebo Light

Other

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

Primary outcomes

  1. Alcohol relapse or lapse

    Time frame: 4 and 12 weeks

    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

Secondary outcomes

  1. Actigraphy

    Time frame: 1 day and third week

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

  2. Alcohol withdrawal severity

    Time frame: 2 weeks

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

  3. Circadian typology

    Time frame: At inclusion

    Chronotype questionnaire (Horne & Östberg) a

  4. Alcohol craving

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

    Obsessive Compulsive Drinking Scale (OCDS)

  5. Depressive and anxious symptomatology

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

    • Montgomery-Åsberg Depression Rating Scale (MADRS)
    • Self-questionnaire : QIDS-SD16 and GAD-7
  6. Suicidal risk

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

    Columbia-Suicide Severity Rating Scale (C-SSRS)

  7. Cognitive impairment

    Time frame: At inclusion, 2 and 12 weeks

    Montreal Cognitive Assessment (MoCA) : three different versions

  8. Light therapy tolerance

    Time frame: At 2 weeks

    Side effects questionnaire designed for a previous study

  9. Polysomnography

    Time frame: 1 week

    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
  10. Subjective quality of sleep

    Time frame: 12 weeks

    Pittsburgh Sleep Quality Index (PSQI)

  11. Number of days with 2 drinks or more

    Time frame: 4, 12 weeks

    % of days with 2 drinks or more at the follow-up visits

  12. Heavy drinking days

    Time frame: 4, 12 weeks

    % of heavy drinking days at the follow-up visits

  13. Days with no drinking

    Time frame: 4, 12 weeks

    % of days with no drinking at the follow-up visits

  14. Percent with complete abstinence

    Time frame: 4 and 12 weeks

    % of subjects with no drinking at the follow-up visits

  15. Number of individuals in relapse

    Time frame: 4 , 12 weeks

    % of subjects meeting criteria for relapse at the follow-up visits

  16. Sleep diary

    Time frame: From inclusion to third week

    sleep diary.give at the first appointment then fill in every day

  17. Circadian typology

    Time frame: one day

    seasonal profile (SPAQ)

  18. Actigraphy

    Time frame: one day to third week

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

  19. Alcohol withdrawal severity

    Time frame: one day to 2 weeks

    mean benzodiazepine dosage required by day during the 2 weeks of treatment

  20. Subjective quality of sleep

    Time frame: one day, 2 day to12 weeks

    Insomnia Severity Index (ISI)

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Alexis GEOFFROY, PhD

CONTACT

[email protected]

+33140256048

Sibylle MAURIES, Ph

CONTACT

[email protected]

+330140256272

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

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

Acronym: LUNA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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