Alcohol Use Disorder, Alcohol Withdrawal
Conditions
Brief summary
This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.
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
Interventions
OTHERLight exposure
30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking)
OTHERPlacebo light
30 minutes exposure to the same device using a filter inactivating light intensity (\< 10 lux)
Sponsors
Centre Hospitalier St Anne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol relapse or lapse | 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
| Measure | Time frame | Description |
|---|---|---|
| Alcohol withdrawal severity | 2 weeks | Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) : maximum and mean score on the first 5 days after admission |
| Circadian typology | At inclusion | Chronotype questionnaire (Horne & Östberg) a |
| Alcohol craving | At inclusion, 1, 2, 4 and 12 weeks | Obsessive Compulsive Drinking Scale (OCDS) |
| Depressive and anxious symptomatology | At inclusion, 1, 2, 4 and 12 weeks | * Montgomery-Åsberg Depression Rating Scale (MADRS) * Self-questionnaire : QIDS-SD16 and GAD-7 |
| Suicidal risk | At inclusion, 1, 2, 4 and 12 weeks | Columbia-Suicide Severity Rating Scale (C-SSRS) |
| Cognitive impairment | At inclusion, 2 and 12 weeks | Montreal Cognitive Assessment (MoCA) : three different versions |
| Light therapy tolerance | At 2 weeks | Side effects questionnaire designed for a previous study |
| Actigraphy | 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® |
| Subjective quality of sleep | 12 weeks | Pittsburgh Sleep Quality Index (PSQI) |
| Number of days with 2 drinks or more | 4, 12 weeks | % of days with 2 drinks or more at the follow-up visits |
| Heavy drinking days | 4, 12 weeks | % of heavy drinking days at the follow-up visits |
| Days with no drinking | 4, 12 weeks | % of days with no drinking at the follow-up visits |
| Percent with complete abstinence | 4 and 12 weeks | % of subjects with no drinking at the follow-up visits |
| Number of individuals in relapse | 4 , 12 weeks | % of subjects meeting criteria for relapse at the follow-up visits |
| Sleep diary | From inclusion to third week | sleep diary.give at the first appointment then fill in every day |
| Polysomnography | 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 |
Countries
France
Contacts
Primary ContactPierre Alexis GEOFFROY, PhD
Backup ContactSibylle MAURIES, Ph
Outcome results
None listed