An interventional study of Light exposure and Placebo light in Alcohol Use Disorder and Alcohol Withdrawal, sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Treatment
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):
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
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 100 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Centre Hospitalier St Anne is the lead sponsor of 99 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Light therapy every morning (8 am-8.30 am)
Other: Light exposure
Dim-Light exposure every morning (8 am-8.30 am)
Other: Placebo light
30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking)
30 minutes exposure to the same device using a filter inactivating light intensity (\< 10 lux)
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
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
Cognitive impairment
Montreal Cognitive Assessment (MoCA) : three different versions
Time frame: At inclusion, 2 and 12 weeks
Light therapy tolerance
Side effects questionnaire designed for a previous study
Time frame: 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
Time frame: 1 week
Subjective quality of sleep
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks
Number of days with 2 drinks or more
% of days with 2 drinks or more at the follow-up visits
Time frame: 4, 12 weeks
Heavy drinking days
% of heavy drinking days at the follow-up visits
Time frame: 4, 12 weeks
Days with no drinking
% of days with no drinking at the follow-up visits
Time frame: 4, 12 weeks
Percent with complete abstinence
% of subjects with no drinking at the follow-up visits
Time frame: 4 and 12 weeks
Number of individuals in relapse
% of subjects meeting criteria for relapse at the follow-up visits
Time frame: 4 , 12 weeks
Sleep diary
sleep diary.give at the first appointment then fill in every day
Time frame: From inclusion to third week
Circadian typology
seasonal profile (SPAQ)
Time frame: 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®
Time frame: one day to third week
Alcohol withdrawal severity
mean benzodiazepine dosage required by day during the 2 weeks of treatment
Time frame: one day to 2 weeks
Subjective quality of sleep
Insomnia Severity Index (ISI)
Time frame: one day, 2 day to12 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Centre Hospitalier St Anne