Adult Emergency Department - Bichât Hospital
Paris, Île-de-France Region, 75018, France
Location status: Recruiting
NCT Number: NCT06878287
This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Paris, Île-de-France Region, 75018, France
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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
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®
Time frame: 2 weeks
Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) : maximum and mean score on the first 5 days after admission
Time frame: At inclusion
Chronotype questionnaire (Horne & Östberg) a
Time frame: At inclusion, 1, 2, 4 and 12 weeks
Obsessive Compulsive Drinking Scale (OCDS)
Time frame: At inclusion, 1, 2, 4 and 12 weeks
Time frame: At inclusion, 1, 2, 4 and 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: At inclusion, 2 and 12 weeks
Montreal Cognitive Assessment (MoCA) : three different versions
Time frame: At 2 weeks
Side effects questionnaire designed for a previous study
Time frame: 1 week
Sleep recording at the sleep laboratory, measuring :
Time frame: 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4, 12 weeks
% of days with 2 drinks or more at the follow-up visits
Time frame: 4, 12 weeks
% of heavy drinking days at the follow-up visits
Time frame: 4, 12 weeks
% of days with no drinking at the follow-up visits
Time frame: 4 and 12 weeks
% of subjects with no drinking at the follow-up visits
Time frame: 4 , 12 weeks
% of subjects meeting criteria for relapse at the follow-up visits
Time frame: From inclusion to third week
sleep diary.give at the first appointment then fill in every day
Time frame: one day
seasonal profile (SPAQ)
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®
Time frame: one day to 2 weeks
mean benzodiazepine dosage required by day during the 2 weeks of treatment
Time frame: one day, 2 day to12 weeks
Insomnia Severity Index (ISI)
Contact information is provided by the study sponsor or research team.
Pierre Alexis GEOFFROY, PhD
CONTACT
Sibylle MAURIES, Ph
CONTACT
Centre Hospitalier St Anne
Other
Bright Light Therapy During Residential Alcohol Withdrawal : a Double Blind Randomized Placebo Controlled Study
Acronym: LUNA
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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