Bright Light Therapy During Residential Alcohol Withdrawal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Light exposure, Placebo light.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder, Alcohol Withdrawal. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bright Light Therapy During Residential Alcohol Withdrawal : a Double Blind Randomized Placebo Controlled Study
Overview
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
- Other Light exposure
30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking) - Other Placebo light
30 minutes exposure to the same device using a filter inactivating light intensity (\< 10 lux)
Primary outcome measures
- Alcohol relapse or lapse [Time frame: 4 and 12 weeks]
Secondary outcome measures (12)
- Actigraphy [Time frame: 1 day and third week]
- Alcohol withdrawal severity [Time frame: 2 weeks]
- Circadian typology [Time frame: At inclusion]
- Alcohol craving [Time frame: At inclusion, 1, 2, 4 and 12 weeks]
- Depressive and anxious symptomatology [Time frame: At inclusion, 1, 2, 4 and 12 weeks]
- Suicidal risk [Time frame: At inclusion, 1, 2, 4 and 12 weeks]
- Cognitive impairment [Time frame: At inclusion, 2 and 12 weeks]
- Light therapy tolerance [Time frame: At 2 weeks]
- Polysomnography [Time frame: 1 week]
- Subjective quality of sleep [Time frame: 12 weeks]
- Number of days with 2 drinks or more [Time frame: 4, 12 weeks]
- Heavy drinking days [Time frame: 4, 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Adult Emergency Department - Bichât Hospital — Paris
Identifiers
NCT: NCT06878287 · D20-P49