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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Active Comparator | Light therapy every morning (8 am-8.30 am) |
|
| Control group | Placebo Comparator | Dim-Light exposure every morning (8 am-8.30 am) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light exposure | Other | 30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Alexis GEOFFROY, PhD | Contact | +33140256048 | pierrealexis.geoffroy@aphp.fr | |
| Sibylle MAURIES, Ph | Contact | +330140256272 | sibylle.mauries@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Alexis GEOFFROY, PhD | University Hospital Group for Psychiatry and Neurosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adult Emergency Department - Bichât Hospital | Recruiting | Paris | Île-de-France Region | 75018 | France |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Placebo light | Other | 30 minutes exposure to the same device using a filter inactivating light intensity (< 10 lux) |
|
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 |
| 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 :
| 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 |